… · xls file · web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090...

1428

Click here to load reader

Upload: trandieu

Post on 26-May-2018

261 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LICENSE HOLDER

NDA/MAL/HDP/6348

NDA/MAL/HDP/6389 METRONIDAZOLE BP

NDA/MAL/HDP/6426

NDA/MAL/HDP/6456

NDA/MAL/HDP/6059 NEUROZONE

NDA/MAL/HDP/7362 TRAM-DOL-50

NDA/MAL/HDP/8249 PANZOL-D

NDA/MAL/HDP/8330 COART

NDA/MAL/HDP/8396 BACK-UP

NDA/MAL/HDP/8469 UNOSOURCE PHARMA LTD. METHICOWEL INJECTION

REGISTRATION NUMBER

LOCAL TECHNICAL REPRESENTATIVE

PRODUCT NAME AND BRAND

ABARIS HEALTHCARE PVT. LTD

ROYAL PHARMA 2011 LIMITED

COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP

ABARIS HEALTHCARE PVT. LTD

ROYAL PHARMA 2011 LIMITED

ABARIS HEALTHCARE PVT. LTD

ROYAL PHARMA 2011 LIMITED

SODIUM CHLORIDE INTRAVENOUS INFUSION BP

ABARIS HEALTHCARE PVT. LTD

ROYAL PHARMA 2011 LIMITED

GLUCOSE INTRAVENOUS INFUSION BP (5% W/V)

RESONANT PHARMACEUTICALS PVT LTD

PNR PHARMACEUTICALS LIMITED

RESONANT PHARMACEUTICALS PVT LTD

PNR PHARMACEUTICALS LIMITED

RESONANT PHARMACEUTICALS PVT LTD

PNR PHARMACEUTICALS LIMITED

RESONANT PHARMACEUTICALS

PNR PHARMACEUTICALS LIMITED

MARIE STOPES INTERNATIONAL

MARIE STOPES UGANDA LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 2: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6369 I CARE PHARMA LIMITED AIVEEN (U) LIMITED AIVXIM SUSPENSION

NDA/MAL/HDP/3011 GYNEST

NDA/MAL/HDP/7243 BAL PHARMA LIMITED HEALTHCARE LTD. EMTRIM

NDA/MAL/HDP/8135 BAL PHARMA LIMITED REGAMOL

NDA/MAL/HDP/8487 BAL PHARMA LIMITED HEALTHCARE LTD. EMTRIM FORTE

NDA/MAL/HDP/6629 NEBILET PLUS 5/25

NDA/MAL/HDP/6239 GSUNATE

NDA/MAL/HDP/7157 CIPLA LTD. LINEZOLID TABLETS 600MG

NDA/MAL/HDP/0816 BENLE CONSULT LIMITED GLIMEPIRIDE DENK 2

NDA/MAL/HDP/0821 BENLE CONSULT LIMITED GLIMEPIRIDE DENK 3

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

SHREEJI PHARMACEUTICALS LIMITED

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

QUALITY CHEMICALS LTD - HUMAN

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

Page 3: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6179 BENLE CONSULT LIMITED

NDA/MAL/HDP/6185 BENLE CONSULT LIMITED DOLOFORTE DENK

NDA/MAL/HDP/6811 BENLE CONSULT LIMITED COVALSAR- DENK 160/12.5

NDA/MAL/HDP/6813 BENLE CONSULT LIMITED COVALSAR- DENK 320/12.5

NDA/MAL/HDP/6814 BENLE CONSULT LIMITED COVALSAR- DENK 80/12.5

NDA/MAL/HDP/6833 BENLE CONSULT LIMITED

NDA/MAL/HDP/8145 BENLE CONSULT LIMITED DENK- AIR 10

NDA/MAL/HDP/8146 BENLE CONSULT LIMITED DENK- AIR JUNIOR 4

NDA/MAL/HDP/8147 BENLE CONSULT LIMITED DENK- AIR JUNIOR 5

DENK PHARMA GMBH & CO KG

ON.SETRON-DENK 4MG ODT

DENK PHARMA GMBH & CO KG

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

ON.SENTRON-DENK 8MG ODT

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

Page 4: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3589 DENK PHARMA GMBH & CO BENLE CONSULT LIMITED SIMVA-DENK 20

NDA/MAL/HDP/1447 VITONA PLUS

NDA/MAL/HDP/3781 ALZANTEL

NDA/MAL/HDP/3932 EPIRAX TABLETS

NDA/MAL/HDP/4401 EPICEPHIN

NDA/MAL/HDP/4413 EPICEPHIN

NDA/MAL/HDP/4417 EPICEPHIN

NDA/MAL/HDP/4419 EPIGONAL 75

NDA/MAL/HDP/4774 FERROFOL VIT-Z

NDA/MAL/HDP/5279 DOSIN

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 5: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6075 OLOHISTINE

NDA/MAL/HDP/6078 TIMOLOL MALEATE

NDA/MAL/HDP/2144 EPICOTIL

NDA/MAL/HDP/2322 TREFLUCAN

NDA/MAL/HDP/3245 NYSTATIN ORAL DROPS

NDA/MAL/HDP/3379 EPIFASI

NDA/MAL/HDP/3502

NDA/MAL/HDP/7686 OPTGENT

NDA/MAL/HDP/8197 AMIKACIN

NDA/MAL/HDP/6236 FREMOL ADVANCE

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

HYDROCORTISONE SODIUM SUCCINATE

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

MOONLINK PHARMACEUTICALS LTD

PLANET PHARMACEUTICALS UGANDA LTD

Page 6: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8314 ZIFAM PINNACLE PTY. LTD. CIPROZIF – 500

NDA/MAL/HDP/4407

NDA/MAL/HDP/2884 ERIS LTD HYCAMTIN

NDA/MAL/HDP/6192 GLAXOSMITHKLINE LIMITED ERIS LTD ENO FRUIT SALT ORANGE

NDA/MAL/HDP/2826 GLAXO SMITH KLINE LTD ERIS LTD PIRITON SYRUP

NDA/MAL/HDP/6116 BENLE CONSULT LIMITED ZOLEDRO-DENK 4MG/5ML

NDA/MAL/HDP/6117 BENLE CONSULT LIMITED GRAN-DENK

NDA/MAL/HDP/4052 HETERO DRUGS LTD EFAVIRENZ

NDA/MAL/HDP/7078 HEXIDINE®

NDA/MAL/HDP/0929 IPCA LABORATORIES LTD DUOQUIN

NDA/MAL/HDP/0248 EAGLEVET UGANDA LIMITED PANTONEX DR-40

BOOTS PHARMACEUTICALS LIMITED

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

SUXAMETHONIUM CHLORIDE- FRESENIUS

NOVARTIS PHARMA SERVICES INC

DENK PHARMA GMBH & CO KG

DENK PHARMA GMBH & CO KG

ABACUS PHARMA (AFRICA) LIMITED

IPCA HEALTH PRODUCTS LTD

METRO PHARMACEUTICALS LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

Page 7: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1747 IPCA LABORATORIES LTD PRESARTAN H 50

NDA/MAL/HDP/2130 IPCA LABORATORIES ZERODOL-LA

NDA/MAL/HDP/2271 EAGLEVET UGANDA LIMITED

NDA/MAL/HDP/3202 IPCA LABORATORIES LTD PRESARTAN-50

NDA/MAL/HDP/6507 IPCA LABORATORIES LTD ZITRAM P

NDA/MAL/HDP/0526 LEBEN LABORATORIES LTD AMILEB- 25

NDA/MAL/HDP/4057 LAMPY

NDA/MAL/HDP/4379 SINURHON

NDA/MAL/HDP/5381 ADIFLAM GEL

NDA/MAL/HDP/5454 MOXILEB

NDA/MAL/HDP/6118 L-TRIM DS

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

ARTEMETHER 20MG/LUMEFANTRINE 120MG

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

Page 8: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6374 PREDLEB-5 DT

NDA/MAL/HDP/7708 LAMPYKLOX CAPSULES

NDA/MAL/HDP/5066 M.J.BIOPHARM PVT LTD TATA UGANDA LIMITED

NDA/MAL/HDP/3175 M.J.BIOPHARM PVT LTD TATA UGANDA LIMITED SPACOVIN

NDA/MAL/HDP/7422 CODAL-SYNTO LTD RENE PHARMACY LTD SYNTOCLAV 625MG

NDA/MAL/HDP/7597 CODAL-SYNTO LTD RENE PHARMACY LTD SYNTOCLAV

NDA/MAL/HDP/8472 CODAL-SYNTO LTD RENE PHARMACY LTD SYNTOCLAV 375MG

NDA/MAL/HDP/0741 MEDOCHEMIE LTD MEDOCIPRIN

NDA/MAL/HDP/5293 MSD (PTY) LIMITED SA ELOCOM LOTION

NDA/MAL/HDP/5256 MSD (PTY) LIMITED SA DIPROFOS INJECTION

LEBEN LABORATORIES PVT. LTD., INDIA

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

DEXAMETHASONE SODIUM PHOSPHATE

BOOTS PHARMACEUTICALS LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 9: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1853 MSD (PTY) LIMITED SA AERIUS ORAL SOLUTION

NDA/MAL/HDP/7012 KIMSY MEDS LTD MYHEP DVIR

NDA/MAL/HDP/8504 KIMSY MEDS LTD LEDVIR

NDA/MAL/HDP/6119 SUPER CV

NDA/MAL/HDP/6144 NIKO

NDA/MAL/HDP/6166 GMICIN

NDA/MAL/HDP/7231 LIGNAT 2%

NDA/MAL/HDP/8221 NEMADOL

NDA/MAL/HDP/6037 AVIT

NDA/MAL/HDP/6595 MOLURAV

NDA/MAL/HDP/2558 RENE INDUSTRIES LTD MYCOREN SUSPENSION

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

RAVIAN LIFE SCIENCE PVT. LTD

ROYAL PHARMA 2011 LIMITED

RENE INDUSTRIES LIMITED

Page 10: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2576 RENE INDUSTRIES LTD RENEQUINE TABLETS

NDA/MAL/HDP/2680 RENE INDUSTRIES LIMITED AMPIREN CAPSULES

NDA/MAL/HDP/2681 RENE INDUSTRIES LIMITED AMOXIREN

NDA/MAL/HDP/2683 RENE INDUSTRIES LTD VITAMIN C

NDA/MAL/HDP/2685 RENE INDUSTRIES LTD RENEDOL(SUSPENSION)

NDA/MAL/HDP/3474 RENE INDUSTRIES LIMITED AMCLOREN DRY SYRUP

NDA/MAL/HDP/3478 RENE INDUSTRIES LIMITED DICLOREN

NDA/MAL/HDP/3582 RENE INDUSTRIES LIMITED SULPHADIMIDINE

NDA/MAL/HDP/3677 RENE INDUSTRIES LTD IBUREN

NDA/MAL/HDP/1666 SANOFI AVENTIS AMARYL 1

NDA/MAL/HDP/6788 ROYAL VIT G

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

LABOREX UGANDA LIMITED

SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 11: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6108 TREVOX 750

NDA/MAL/HDP/6109 MEXLO

NDA/MAL/HDP/6111 MOTIFAST

NDA/MAL/HDP/6112 SULTOLIN

NDA/MAL/HDP/6139 SERVIN CAPSULE

NDA/MAL/HDP/6182 ALARID

NDA/MAL/HDP/6623 REFINAC SR

NDA/MAL/HDP/6624 CIPROKEN

NDA/MAL/HDP/0075 SYNRIAM

NDA/MAL/HDP/3999 PANSEC DR

NDA/MAL/HDP/5167 BRUSTAN TABLETS

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD.PABNA UNIT

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD.PABNA UNIT

GAMA PHARMACEUTICALS (U) LIMITED

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

Page 12: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5479 RANFERON 12 CAPSULES

NDA/MAL/HDP/6360 ETOCOXX 90MG

NDA/MAL/HDP/6368 ETOCOXX 120MG

NDA/MAL/HDP/1009 BUPITROY 0.5%

NDA/MAL/HDP/0920 BUPITROY HEAVY

NDA/MAL/HDP/0725 SPASMOTROY 40

NDA/MAL/HDP/4958 BENZOSED

NDA/MAL/HDP/5316 DYNAPAR

NDA/MAL/HDP/5318 DYNAPAR AQ (1ML)

NDA/MAL/HDP/5319 DYNAPAR SR

NDA/MAL/HDP/8343 XYKAA EXTEND 1000

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

Page 13: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6122 ROCUTROY

NDA/MAL/HDP/1102 MATRIX UGANDA LTD OVUREX

NDA/MAL/HDP/1683 VOREN PLUS

NDA/MAL/HDP/8205 ANLODIN

NDA/MAL/HDP/0152 RYCARDON 150

NDA/MAL/HDP/0153 RYCARDON 300

NDA/MAL/HDP/0127 CORYCARDON

NDA/MAL/HDP/0128 CORYCARDON

NDA/MAL/HDP/0152 RYCARDON 150

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

ROYAL PHARMA 2011 LIMITED

Y.S.P INDUSTRIES (M) SDN BHD

ROYAL PHARMA 2011 LIMITED

Y.S.P INDUSTRIES (M) SDN BHD

ROYAL PHARMA 2011 LIMITED

DELORBIS PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

DELORBIS PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

DELORBIS PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

DELORBIS PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

DELORBIS PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

Page 14: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0153 RYCARDON 300

NDA/MAL/HDP/2394 MERCK SHARP & DOHME BV STOCRIN

NDA/MAL/HDP/1869 MERCK SHARP & DOHME BV STOCRIN 200

NDA/MAL/HDP/2037 MERCK SHARP & DOHME BV STOCRIN 50

NDA/MAL/HDP/8488 ZIM LABORATORIES LTD CEFRAZ 200

NDA/MAL/HDP/6405 ZIM LABORATORIES LTD CLOPRAZ

NDA/MAL/HDP/6407 ZIM LABORATORIES LTD ZIMCOX 200

NDA/MAL/HDP/6444 ZIM LABORATORIES LTD CEFRAZ 100

NDA/MAL/HDP/7029 ZIM LABORATORIES LTD LIPIZAR 20

NDA/MAL/HDP/8653 LEFLOXIN 500

DELORBIS PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

PSA INTERNATIONAL (EXPORT DIVISION OF PSA CHEMICALS AND PHARMACEUTICALS PVT. LTD)

ROYAL PHARMA 2011 LIMITED

Page 15: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5497 ABACUS PHARMA (A) LTD. EXPEN

NDA/MAL/HDP/8108 ORS

NDA/MAL/HDP/4358 LIOTON

NDA/MAL/HDP/2395 FASTUM GEL

NDA/MAL/HDP/3504 BIFRIL

NDA/MAL/HDP/7288

NDA/MAL/HDP/7656 SPASMOMEN

NDA/MAL/HDP/0348 XBETA

NDA/MAL/HDP/1122 ABCHLOR EAR DROPS

NDA/MAL/HDP/0558 ABGENTA EYE DROPS

ABACUS PHARMA (AFRICA) LIMITED

MEDIPHARM INDUSTRIES LTD

MEDIPHARM SALES LIMITED

A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

A.MENARINI INDUSTRIE FARMACEUTICHE S.R.I

STAR PHARMACEUTICALS LTD

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

KETESSE FILM COATED TABLETS

A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

Page 16: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1368 D5

NDA/MAL/HDP/0889 DNS

NDA/MAL/HDP/1370

NDA/MAL/HDP/4784 D50

NDA/MAL/HDP/4910 FLUZOL

NDA/MAL/HDP/6820 ABBORI EAR DROPS

NDA/MAL/HDP/7674 ABLEVOX

NDA/MAL/HDP/8359 ASUNATE 120

NDA/MAL/HDP/6812 NOFLOX

NDA/MAL/HDP/3866 RL

NDA/MAL/HDP/4702 ABTOL 20%W/V

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

STERILIZED WATER FOR INJECTION

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

Page 17: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4703 ABGYL

NDA/MAL/HDP/3411 ABNAL NASAL DROPS

NDA/MAL/HDP/6815 ABCROM EYE DROPS

NDA/MAL/HDP/0077 X-SONE

NDA/MAL/HDP/0002 X-SONE-N

NDA/MAL/HDP/0080 ABWATER

NDA/MAL/HDP/0619 D10

NDA/MAL/HDP/0491 ABCHLOR EYE DROPS

NDA/MAL/HDP/0633 CIPROCIN

NDA/MAL/HDP/0638 ABLOL-5 EYE DROPS

NDA/MAL/HDP/4030 XBETA- N

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

Page 18: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4394 NS

NDA/MAL/HDP/4796

NDA/MAL/HDP/1849 CIFIN

NDA/MAL/HDP/7154

NDA/MAL/HDP/5311 DUPHASTON TABLETS

NDA/MAL/HDP/8234 INFUVAC 2015

NDA/MAL/HDP/8491 MERCK (PTY) LTD CETROTIDE 0.25MG

NDA/MAL/HDP/3831 ABBVIE (PTY) LTD ALUVIA

NDA/MAL/HDP/1661 ABBVIE (PTY) LTD ALUVIA 100/25

NDA/MAL/HDP/2087 ABBVIE LOGISTICS BV NORVIR

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

DARROWS SOLUTION (HALF STRENGTH)

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABARIS HEALTHCARE PVT. LTD

ROYAL PHARMA 2011 LIMITED

CIPROFLOXACIN HYDROCHLORIDE

ABBOTT HEALTHCARE PRODUCTS B.V.

STAR PHARMACEUTICALS LTD

ABBOT LABORATORIES S.A. (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

MEDICAL ACCESS (UGANDA) LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

Page 19: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6243 ABBVIE (PTY) LTD SURVANTA

NDA/MAL/HDP/0120 TARAKA 240/4

NDA/MAL/HDP/4736 ACINO PHARMA AG MEPHAQUIN LACTAB

NDA/MAL/HDP/3005 ACINO PHARMA AG OLFEN-100 SR DEPOCAPS

NDA/MAL/HDP/3686 ACINO PHARMA AG NEURORUBINE

NDA/MAL/HDP/8241 ACINO PHARMA AG CLOPACIN

NDA/MAL/HDP/3804 ACINO PHARMA AG NEURORUBINE

NDA/MAL/HDP/4626 ACINO PHARMA AG GASEC-20

NDA/MAL/HDP/2774 ACINO PHARMA AG BACTIFLOX NEO 500

NDA/MAL/HDP/3532 ACINO PHARMA AG SIMEPAR CAPSULES

NDA/MAL/HDP/0005 ALPRAZEC 0.25

UNITED HEALTHCARE DISTRIBUTORS LTD

ABOTT LABORATORIES S.A (PTY) LIMITED

LABOREX UGANDA LIMITED

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

STALLION LABORATORIES PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

Page 20: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4875 PHARM ACCESS AFRICA LTD MISOCLEAR

NDA/MAL/HDP/0008 OMEPRIC

NDA/MAL/HDP/0351 MANKIND PHARM LTD TATA UGANDA LIMITED DEPREGDINA

NDA/MAL/HDP/0010 02-LON

NDA/MAL/HDP/8328 AZITHROCIN

NDA/MAL/HDP/7344 ACULIFE HEALTHCARE SUPER MEDIC LTD HEPANIR

NDA/MAL/HDP/0058 NIRMA LIMITED. SUPER MEDIC LTD WATER FOR INJECTION B.P.

NDA/MAL/HDP/4398 SUPER MEDIC LTD SODIUM CHLORIDE

NDA/MAL/HDP/4955 NIRMA LIMITED. SUPER MEDIC LTD

NDA/MAL/HDP/5110 NIRMA LIMITED. SUPER MEDIC LTD GLUCOSE INFUSION BP

NDA/MAL/HDP/5214 NIRMA LIMITED. SUPER MEDIC LTD NIRMET

MARIE STOPES UGANDA LIMITED

STALLION LABORATORIES PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

STALLION LABORATORIES PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

RESONANT PHARMACEUTICALS

PNR PHARMACEUTICALS LIMITED

NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARE

COMPOUND SODIUM LACTATE INFU.

Page 21: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5427 NIRMA LIMITED. SUPER MEDIC LTD NIRCIP

NDA/MAL/HDP/3208 NIRMA LIMITED. SUPER MEDIC LTD NIRFOL 1%

NDA/MAL/HDP/7189 ACULIFE HEALTHCARE SUPER MEDIC LTD MERONIR

NDA/MAL/HDP/7255 ACULIFE HEALTHCARE SUPER MEDIC LTD NIRIXONE

NDA/MAL/HDP/8317 ACULIFE HEALTHCARE SUPER MEDIC LTD MERONIR 500

NDA/MAL/HDP/8318 ACULIFE HEALTHCARE SUPER MEDIC LTD B-CANE HEAVY

NDA/MAL/HDP/4356 ADCOCK INGRAM LIMITED FRESHEN

NDA/MAL/HDP/6079 ADCOCK INGRAM LIMITED ALLERGEX

NDA/MAL/HDP/6758 ADCOCK INGRAM LIMITED ADCO-NAPAMOL

NDA/MAL/HDP/6759 ADCOCK INGRAM LIMITED BETAPYN

NDA/MAL/HDP/6763 ADCOCK INGRAM LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

COMPRAL HEADACHE TABLETS

Page 22: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0496 ADCOCK INGRAM LIMITED MYPRODOL

NDA/MAL/HDP/0713 BENLE CONSULT LIMITED PANTO-DENK 20

NDA/MAL/HDP/0715 BENLE CONSULT LIMITED PANTO-DENK 40

NDA/MAL/HDP/6060 TAMUXXAIR

NDA/MAL/HDP/1805 MSD (PTY) LIMITED SA JANUMET

NDA/MAL/HDP/1873 MSD (PTY) LIMITED SA JANUMET

NDA/MAL/HDP/6783 ABBVIE (PTY) LTD FORANE

NDA/MAL/HDP/2453 ABBVIE (PTY) LTD NORVIR

NDA/MAL/HDP/3506 ABBVIE (PTY) LTD ULTANE

NDA/MAL/HDP/3760

NDA/MAL/HDP/4701 MEBRONE 100 TABLETS

UGANDA HEALTH MARKETING GROUP LIMITED

DENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES.

SURGIPHARM (U) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

MEDICAL ACCESS (UGANDA) LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

COMPOUND MAGNESIUM TRISILICATE

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

Page 23: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4928 FOLIC ACID TABLETS

NDA/MAL/HDP/4971 FRUSEMIDE TABLETS

NDA/MAL/HDP/2243 SIMDOL TABLETS

NDA/MAL/HDP/3021 AGOG PHARMA LTD GLIBENCLAMIDE TABLETS

NDA/MAL/HDP/3035 AGOG PHARMA LTD AGOFORTE TONIC

NDA/MAL/HDP/3037 AGOG PHARMA LIMITED AGOVIT SYRUP

NDA/MAL/HDP/3040 AGOG PHARMA LTD AGODOX

NDA/MAL/HDP/3048 AGOG PHARMA LIMITED TRIMAGO-DS TABLETS

NDA/MAL/HDP/3057 AGOG PHARMA LIMITED COLD-A-GO CAPSULES

NDA/MAL/HDP/3060 AGOG PHARMA LIMITED KETOS TABLET

NDA/MAL/HDP/3067 AGOG PHARMA LIMITED PROMAGO SYRUP

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 24: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3072 AGOG PHARMA LIMITED AGOMOL TABLETS(THANE)

NDA/MAL/HDP/3085 AGOG PHARMA LIMITED AGOCOLD TABLETS

NDA/MAL/HDP/3031 AGOG PHARMA LTD AGOMETHASONE

NDA/MAL/HDP/3063 AGOG PHARMA LIMITED AGODIC-50

NDA/MAL/HDP/1247 AGOG PHARMA LTD PROCIP

NDA/MAL/HDP/1087 AGOG PHARMA LIMITED AGOCYCLINE

NDA/MAL/HDP/3023 AGOG PHARMA LTD AGOTRAX

NDA/MAL/HDP/1136 AGOG PHARMA LTD. AGOSCAB APPLICATION

NDA/MAL/HDP/1139 AGOG PHARMA LTD. AGOVATE

NDA/MAL/HDP/1056 AGOG PHARMA LTD. AGOVATE-N OINTMENT

NDA/MAL/HDP/1049 AGOG PHARMA LTD. AGOVATE

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 25: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1140 AGOG PHARMA LTD. AGOVATE-N

NDA/MAL/HDP/1598 AGOG PHARMA LTD AGOCIM 400

NDA/MAL/HDP/1474 AGOG PHARMA LTD AGODIC

NDA/MAL/HDP/0670 AGOG PHARMA LTD FLUNAZ-200

NDA/MAL/HDP/0677 AGOG PHARMA LTD DOPAMET

NDA/MAL/HDP/1123 AGOG PHARMA LIMITED AGOPAR

NDA/MAL/HDP/0463 AGOG PHARMA LTD TOPHEN

NDA/MAL/HDP/1242 AGOG PHARMA LTD TOPHEN-100

NDA/MAL/HDP/1476 AGOG PHARMA LTD SEPTOL

NDA/MAL/HDP/0694 AGOG PHARMA LTD. DT ZINC-20 TABLETS

NDA/MAL/HDP/1660 AGOG PHARMA LIMITED AGOCIM-200

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 26: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1786 AGOG PHARMA LTD AGONAC TABLETS (THANE)

NDA/MAL/HDP/2075 AGOG PHARMA LTD AGOPRED

NDA/MAL/HDP/2076 AGOG PHARMA LTD AGOMIDE

NDA/MAL/HDP/2098 AGOG PHARMA LTD AGO QUININE

NDA/MAL/HDP/2320 AGOG PHARMA LTD ERO-125

NDA/MAL/HDP/2995 AGOG PHARMA LTD GALLOP

NDA/MAL/HDP/3367 AGOG PHARMA LIMITED AGOMOL SUSPENSION

NDA/MAL/HDP/3378 AGOG PHARMA LTD CHLOZINE TABLETS

NDA/MAL/HDP/3383 AGOG PHARMA LTD ZEPIN

NDA/MAL/HDP/3634 AGOG PHARMA LTD AGOPLUS

NDA/MAL/HDP/0105 AGOG PHARMA LIMITED AGOSPRIN TABLETS

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 27: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1100 AGOG PHARMA LTD AGOVIR SKIN CREAM

NDA/MAL/HDP/0635 AGOG PHARMA LIMITED AGO-AMIN

NDA/MAL/HDP/0088 AGOG PHARMA LTD D-LYTE CO-PACK

NDA/MAL/HDP/1427 AGOG PHARMA LTD. TENA-50

NDA/MAL/HDP/1054 AGOG PHARMA LIMITED AZ-250

NDA/MAL/HDP/0835 AGOG PHARMA LTD. AGOBIS

NDA/MAL/HDP/1138 AGOG PHARMA LTD AGO-CALAMINE

NDA/MAL/HDP/1616 AGOG PHARMA LIMITED CEZIN

NDA/MAL/HDP/1124 AGOG PHARMA LTD AGO SCRUB

NDA/MAL/HDP/1142 AGOG PHARMA LTD CANDIZOL

NDA/MAL/HDP/0007 AGOG PHARMA LTD PROCIP SYRUP

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 28: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0674 AGOG PHARMA LTD AGODAPS-100

NDA/MAL/HDP/0688 AGOG PHARMA LTD HBB

NDA/MAL/HDP/0422 AGOG PHARMA LTD PARAFLAM

NDA/MAL/HDP/0679 AGOG PHARMA MEFENA-250 CAPSULES

NDA/MAL/HDP/1052 AGOG PHARMA LTD MICLOGEN

NDA/MAL/HDP/1566 AGOG PHARMA LIMITED VITAVIT

NDA/MAL/HDP/0689 AGOG PHARMA LTD AGONAL

NDA/MAL/HDP/1103 AGOG PHARMA LTD AGOCIN CREAM

NDA/MAL/HDP/0902 AGOG PHARMA LTD AGOPINE SR

NDA/MAL/HDP/0672 AGOG PHARMA LIMITED AGONOR TABLETS

NDA/MAL/HDP/0045 AGOG PHARMA LTD AGOMOL

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 29: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1544 AGOG PHARMA LTD

NDA/MAL/HDP/1079 AGOG PHARMA LIMITED AGOG-QUINE SYRUP

NDA/MAL/HDP/0022 AGOG PHARMA LTD QUININE SULPHATE

NDA/MAL/HDP/0101 AGOG PHARMA LIMITED

NDA/MAL/HDP/0423 AGOG PHARMA LIMITED AGOTRAM

NDA/MAL/HDP/1265 AGOG PHARMA LTD COMBIPLEX

NDA/MAL/HDP/3746 AGOG PHARMA LIMITED BENDRO

NDA/MAL/HDP/3748 AGOG PHARMA LIMITED AGOSPIRIN

NDA/MAL/HDP/3773 AGOG PHARMA LTD AGOBUTOL-4

NDA/MAL/HDP/3794 AGOG PHARMA LTD AGOMET-200 (THANE)

NDA/MAL/HDP/3860 AGOG PHARMA LIMITED AGOLAC

GITTOES PHARMACEUTICALS LIMITED

PROMETHAZINE HYDROCHLORIDE B.P

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AGOTETRA CAPSULES (THANE)

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 30: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3991 AGOG PHARMA LIMITED AGOFULVIN

NDA/MAL/HDP/3996 AGOG PHARMA LIMITED AGOTOIN TABLETS

NDA/MAL/HDP/3998 AGOG PHARMA LIMITED AGOKOFF SYRUP

NDA/MAL/HDP/4001 AGOG PHARMA LIMITED AGOCOLD PLUS SYRUP

NDA/MAL/HDP/4002 AGOG PHARMA LIMITED AGOCID

NDA/MAL/HDP/4064 AGOG PHARMA LTD. TERAFINE

NDA/MAL/HDP/4188 AGOG PHARMA LIMITED AGOPRAZ

NDA/MAL/HDP/4329 AGOG PHARMA LIMITED AGO-CPM

NDA/MAL/HDP/4406 AGOG PHARMA SATISFIL -100

NDA/MAL/HDP/4526 AGOG PHARMA LIMITED AZ-500

NDA/MAL/HDP/4598 AGOG PHARMA LTD AZ-250

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 31: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4605 AGOG PHARMA LIMITED AGODRYL SYRUP

NDA/MAL/HDP/4751 AGOG PHARMA LTD FEROL

NDA/MAL/HDP/4766 AGOBEN SUSPENSION

NDA/MAL/HDP/4769 AGOG PHARMA LTD AGOBEX

NDA/MAL/HDP/4805 AGOG PHARMA LTD AGOFEN

NDA/MAL/HDP/4806 AGOG PHARMA LTD AGOFER

NDA/MAL/HDP/4807 AGOG PHARMA LTD AGOFORMIN

NDA/MAL/HDP/4809 AGOG PHARMA LTD AGOCORT

NDA/MAL/HDP/4811 AGOG PHARMA LTD AGOGYL

NDA/MAL/HDP/4812 AGOG PHARMA LTD AGOMETROL SUSPENSION

NDA/MAL/HDP/4813 AGOG PHARMA LTD

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AGOMETROL TABLETS (THANE)

Page 32: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4836 AGOG PHARMA LIMITED METRON

NDA/MAL/HDP/4903 AGOG PHARMA LTD. CMT-TABLETS

NDA/MAL/HDP/4924 AGOG PHARMA LIMITED MULTIVIT TABLET

NDA/MAL/HDP/4940 AGOG PHARMA LTD FOLON

NDA/MAL/HDP/5115 AGOG PHARMA LTD. INDOS-25(THANE)

NDA/MAL/HDP/5188 AGOG PHARMA LTD. ITRAZ CAPSULES

NDA/MAL/HDP/5272 AGOG PHARMA LTD DIX

NDA/MAL/HDP/5302 AGOG PHARMA LTD IBUGO-COMBI

NDA/MAL/HDP/5305 AGOG PHARMA LIMITED IBUGO

NDA/MAL/HDP/5419 AGOG PHARMA LIMITED AGO-CPM

NDA/MAL/HDP/5429 AGOG PHARMA LIMITED CIPRO-500

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 33: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5435 AGOG PHARMA LTD PIC

NDA/MAL/HDP/5464 AGOG PHARMA LIMITED CO-METHER

NDA/MAL/HDP/5482 AGOG PHARMA LTD AGOLIN

NDA/MAL/HDP/5495 AGOG PHARMA LTD AGOCAL TABLETS

NDA/MAL/HDP/6041 AGOG PHARMA LTD CANDIZOL

NDA/MAL/HDP/6142 AGOG PHARMA LIMITED AGOCARB

NDA/MAL/HDP/6190 AGOG PHARMA LTD D-LYTE

NDA/MAL/HDP/6213 AGOG PHARMA LTD AGOXIN 250 DT

NDA/MAL/HDP/1748 AGOG PHARMA LIMITED AZ-500

NDA/MAL/HDP/1782 AGOG PHARMA LTD CO-METHER

NDA/MAL/HDP/1809 AGOG PHARMA LIMITED AGOVIT-6

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 34: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1810 AGOG PHARMA LIMITED AGOTRI

NDA/MAL/HDP/1895 AGOG PHARMA LTD TRIMAGO (PAEDIATRIC)

NDA/MAL/HDP/1900 AGOG PHARMA LTD AGOM 20

NDA/MAL/HDP/1997 AGOG PHARMA LTD TENA-100

NDA/MAL/HDP/2007 AGOG PHARMA LIMITED B-COX TABLETS

NDA/MAL/HDP/2019 AGOG PHARMA LIMITED AGOHAL

NDA/MAL/HDP/2031 AGOG PHARMA LTD. AGOZID TABLETS

NDA/MAL/HDP/2095 AGOG PHARMA LIMITED AGOMOL

NDA/MAL/HDP/2282 AGOG PHARMA LTD PROPAN

NDA/MAL/HDP/2335 AGOG PHARMA LTD. AGOBEN TABLETS(THANE)

NDA/MAL/HDP/2349 AGOG PHARMA LTD D-LYTE

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 35: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2571 AGOG PHARMA LTD CO-METHER

NDA/MAL/HDP/2594 AGOG PHARMA LTD FEF

NDA/MAL/HDP/2946 AGOG PHARMA LTD

NDA/MAL/HDP/2947 AGOG PHARMA LTD TRIMAGO TABLETS

NDA/MAL/HDP/3003 AGOG PHARMA LTD AGOVIR

NDA/MAL/HDP/3013 AGOG PHARMA LTD AGOZOLE

NDA/MAL/HDP/3029 AGOG PHARMA LIMITED AGOZOLE SUSPENSION

NDA/MAL/HDP/3064 AGOG PHARMA LTD TIN-TIN TABLETS

NDA/MAL/HDP/3069 AGOG PHARMA LTD AGOMOVE CAPSULES

NDA/MAL/HDP/3219 AGOG PHARMA LIMITED

NDA/MAL/HDP/3246 AGOG PHARMA LTD

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

TRIMAGO ORAL SUSPENSION(THANE)

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AGOPHENOL ORAL SUSPENSION

GITTOES PHARMACEUTICALS LIMITED

COMPOUND MAGNESIUM TRISILICATE

Page 36: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3255 AGOG PHARMA LTD SATISFIL-50

NDA/MAL/HDP/3315 AGOG PHARMA LTD ERO-250 TABLETS

NDA/MAL/HDP/3377 AGOG PHARMA LTD AMILINE

NDA/MAL/HDP/3382 AGOG PHARMA LTD AGOFEN SUSPENSION

NDA/MAL/HDP/3391 AGOG PHARMA LTD CEZIN TABLET

NDA/MAL/HDP/3451 AGOG PHARMA LIMITED

NDA/MAL/HDP/3647 AGOG PHARMA LTD

NDA/MAL/HDP/6631 AGOG PHARMA LTD AGOBURN

NDA/MAL/HDP/8151 AGOG PHARMA LTD AGO-C (THANE)

NDA/MAL/HDP/8154 AGOG PHARMA LTD AGOGCORT

NDA/MAL/HDP/8157 AGOG PHARMA LTD D LYTE- PLAIN

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AGOPHENOL CAPSULES (THANE0

GITTOES PHARMACEUTICALS LIMITED

NYSTAGO ORAL SUSPENSION

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 37: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8178 AGOG PHARMA LTD NYSTAGO TABLETS

NDA/MAL/HDP/3790 AGOG PHARMA AGOFLOX-P

NDA/MAL/HDP/3985 AGOG PHARMA LTD AGOMYCIN SUSPENSION

NDA/MAL/HDP/7241 EXPHAR SA. GENTASOL

NDA/MAL/HDP/4995 ROYAL GROUP

NDA/MAL/HDP/1078 MICRO LABS LTD LEVOBACT INFUSION

NDA/MAL/HDP/0575 MICRO LABS LTD MICROMOX

NDA/MAL/HDP/5073 CADILA HEALTHCARE LTD DEXONA EYE/EAR DROP

NDA/MAL/HDP/6082 EXPHAR SA CROMSOL

NDA/MAL/HDP/6354 EXPHAR SA. TIMOSOL ®

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

SURGIPHARM (U) LIMITED

HARLEYS UGANDA LIMITED

GENTABACT EYE/EAR DROPS

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

ABACUS PHARMA (AFRICA) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 38: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6537 EXPHAR SA CARBOSOL

NDA/MAL/HDP/6202 KIMSY MEDS LTD SALPRAZ 20

NDA/MAL/HDP/7707 KIMSY MEDS LTD ZOLIGLIT 15

NDA/MAL/HDP/8128 KIMSY MEDS LTD ATOREG 10

NDA/MAL/HDP/8132 KIMSY MEDS LTD ZOLIGLIT 30

NDA/MAL/HDP/8134 KIMSY MEDS LTD SALPRAZ 40

NDA/MAL/HDP/8129 KIMSY MEDS LTD ATOREG 20

NDA/MAL/HDP/0941 AJANTA PHARMA LTD ZAHA

NDA/MAL/HDP/3899 AJANTA PHARMA LTD FEDATE SYRUP

NDA/MAL/HDP/4713 AJANTA PHARMA LTD MEFLAM

SURGIPHARM (U) LIMITED

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 39: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1901 AJANTA PHARMA LTD 31-0 IBUMOL

NDA/MAL/HDP/6617 AJANTA PHARMA LTD APFLU

NDA/MAL/HDP/8353 AJANTA PHARMA LIMITED NURIFER CAPSULES

NDA/MAL/HDP/2552 AJANTA PHARMA LTD CAROFIT

NDA/MAL/HDP/8346 AJANTA PHARMA LIMITED ADERAN 8

NDA/MAL/HDP/0959 AJANTA PHARMA LTD 31-0

NDA/MAL/HDP/1615 AJANTA PHARMA LTD APCALIS SX

NDA/MAL/HDP/3874 AJANTA PHARMA LTD 31-0 RIDMAL 40/320

NDA/MAL/HDP/2040 AJANTA PHARMA LTD ARTEFAN 20/120

NDA/MAL/HDP/3515 AJANTA PHARMA LTD ARTEFAN 40/240

NDA/MAL/HDP/3653 AJANTA PHARMA LTD ARTEFAN

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ARTEFAN DISPERSIBLE 20/120

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 40: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8078 AJANTA PHARMA LTD APMOD 100/270

NDA/MAL/HDP/1796 AJANTA PHARMA LTD ZAHA 250

NDA/MAL/HDP/2005 AJANTA PHARMA LTD KAMAGRA-100

NDA/MAL/HDP/2272 AJANTA PHARMA LTD CLARANTA -500

NDA/MAL/HDP/4325 AJANTA PHARMA LTD 31-0 ACTINAC 100

NDA/MAL/HDP/4365 AJANTA PHARMA LTD ACTINAC PLUS

NDA/MAL/HDP/7355 AJANTA PHARMA LIMITED ARTEFAN SUSPENSION

NDA/MAL/HDP/3827 AJANTA PHARMA LTD ATORFIT-10

NDA/MAL/HDP/4801 AJANTA PHARMA LTD DAZEL KIT

NDA/MAL/HDP/1478 AJANTA PHARMA LTD KAMAGRA

NDA/MAL/HDP/3551 AJANTA PHARMA LTD ZAHA-500MG

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 41: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0964 AJANTA PHARMA LTD APMOD 25 / 67.5

NDA/MAL/HDP/0963 AJANTA PHARMA LTD APMOD

NDA/MAL/HDP/0928 AJANTA PHARMA LTD INSTACLOP 75

NDA/MAL/HDP/5379 AJANTA PHARMA LTD ZOLANAS-30

NDA/MAL/HDP/3702 AJANTA PHARMA LTD ATORFIT-20

NDA/MAL/HDP/6612 AJANTA PHARMA LIMITED APRAZOLE PLUS-20

NDA/MAL/HDP/7735 AJANTA PHARMA LIMITED IBUMOL 400

NDA/MAL/HDP/6090 UNOSOURCE PHARMA LTD PROSTAR 200

NDA/MAL/HDP/8321 UNOSOURCE PHARMA LTD. PROSTER- 200 CAPSULES

NDA/MAL/HDP/6209 UNOSOURCE PHARMA LTD RESPIWEL 4

NDA/MAL/HDP/6440 UNOSOURCE PHARMA LTD. CEFIWEL 400

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 42: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7912 UNOSOURCE PHARMA LTD. GLIMEWEL M-1

NDA/MAL/HDP/8107 UNOSOURCE PHARMA LTD. WELRAB 20

NDA/MAL/HDP/8640 UNOSOURCE PHARMA LTD. CORTUM 250

NDA/MAL/HDP/0030 UNOSOURCE PHARMA LTD TRADMIN

NDA/MAL/HDP/6165 UNOSOURCE PHARMA LTD. CEFTRISONE - 1000

NDA/MAL/HDP/6167 UNOSOURCE PHARMA LTD. AKUROSE

NDA/MAL/HDP/7692 UNOSOURCE PHARMA LTD. CEFECTRON-S 1.5 G

NDA/MAL/HDP/7740 UNOSOURCE PHARMA LTD. METHICOWEL 1500

NDA/MAL/HDP/7745 UNOSOURCE PHARMA LTD. TAZOGARD

NDA/MAL/HDP/7747 UNOSOURCE PHARMA LTD. THERMODOL

NDA/MAL/HDP/7695 UNOSOURCE PHARMA LTD. CORTUM 500

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ESCORTS PHARMACEUTICALS LIMITED

Page 43: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8106 UNOSOURCE PHARMA LTD. PLENMOXI

NDA/MAL/HDP/4318 UNOSOURCE PHARMA LTD. AKUGABALIN

NDA/MAL/HDP/6086 UNOSOURCE PHARMA LTD ACEWEL-P

NDA/MAL/HDP/6141 UNOSOURCE PHARMA LTD ACEWEL

NDA/MAL/HDP/6141 UNOSOURCE PHARMA LTD ACEWEL

NDA/MAL/HDP/8356 UNOSOURCE PHARMA LTD LORFACT-D

NDA/MAL/HDP/7751 UNOSOURCE PHARMA LTD. UNODEX COUGH SYRUP

NDA/MAL/HDP/8648 UNOSOURCE PHARMA LTD. UNODEX PLUS

NDA/MAL/HDP/6181 UNOSOURCE PHARMA LTD. AZINOWEL-500

NDA/MAL/HDP/6622 UNOSOURCE PHARMA LTD. CEFIWEL-100 DT

NDA/MAL/HDP/6647 UNOSOURCE PHARMA LTD. JOYCLAV -625

ABACUS PHARMA (AFRICA) LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ESCORTS PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ESCORTS PHARMACEUTICALS LIMITED

Page 44: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6656 UNOSOURCE PHARMA LTD. PLENMOXI

NDA/MAL/HDP/6669 UNOSOURCE PHARMA LTD. SUPER WELGRA -100

NDA/MAL/HDP/7098 UNOSOURCE PHARMA LTD. ACEFORCE SP

NDA/MAL/HDP/7123 UNOSOURCE PHARMA LTD. MARTINEZ 10

NDA/MAL/HDP/8105 UNOSOURCE PHARMA LTD. XERIN

NDA/MAL/HDP/2416 IDA KIMSY MEDS LTD

NDA/MAL/HDP/2768 ECONOPRED PLUS

NDA/MAL/HDP/0572 S.A.ALCON COUVREUR N.V AZARGA

NDA/MAL/HDP/1738 ALCON PHARMACEUTICALS TEARS NATURALE II

NDA/MAL/HDP/1864 ALCON PHARMACEUTICALS PATANOL

NDA/MAL/HDP/2050 ALCON PHARMACEUTICALS ISOPTO CARPINE 2%

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

SODIUM STIBOGLUCONATE INJECTION

ALCON PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

Page 45: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2545 ALCON PHARMACEUTICALS TOBREX

NDA/MAL/HDP/2974 ALCON PHARMACEUTICALS TRAVATAN

NDA/MAL/HDP/3331 ALCON PHARMACEUTICALS BETOPTIC

NDA/MAL/HDP/3718 ISOPTO ATROPINE 1%

NDA/MAL/HDP/4321 ALCON CUSI S.A CUSIMOLOL 0.5%

NDA/MAL/HDP/4326 ALCON CUSI S.A CUSICROM 4% EYE DROPS

NDA/MAL/HDP/2961 ALCON CUSI S.A

NDA/MAL/HDP/7706 CACEF 200

NDA/MAL/HDP/1080 ZOCEF 250 TABLETS

NDA/MAL/HDP/3948 TAXIM-O

NDA/MAL/HDP/4361 TAXIM-O

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

ALCON PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

OFTALMOLOSA CUSI ERYTHROMYCIN 0.5%

CACHET PHARMACEUTICALS PVT LIMITED

ASTRA PHARMA (U) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

Page 46: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4577 MAGTAM

NDA/MAL/HDP/4677 ZOCEF

NDA/MAL/HDP/4678 ZOCEF-500

NDA/MAL/HDP/2640 RENE PHARMACY LTD

NDA/MAL/HDP/3616 ZAXTER

NDA/MAL/HDP/3685 AIVEEN (U) LIMITED ODICEF

NDA/MAL/HDP/0521 PAN 40

NDA/MAL/HDP/1954 RAPEED-20

NDA/MAL/HDP/8485 TRIAXON

NDA/MAL/HDP/2120 MEGAPIME

NDA/MAL/HDP/8495 CACEF 50

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

CIRON DRUGS & PHARMACEUTICALS PVT LTD

BENZYL BENZOATE APPLICATION

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

GALPHAR LABORATORIES LTD

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

CACHET PHARMACEUTICALS PVT LIMITED

ASTRA PHARMA (U) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CACHET PHARMACEUTICALS PRIVATE LIMITED

ASTRA PHARMA (U) LIMITED

Page 47: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4556 CLAVAM 375

NDA/MAL/HDP/4568 CLAVAM 625

NDA/MAL/HDP/4573 CLAVAM DT 228.5MG

NDA/MAL/HDP/4581 CLAVAM 1000

NDA/MAL/HDP/6496 NEUROKEM 150

NDA/MAL/HDP/1568 CLAVAM

NDA/MAL/HDP/8334 PRIDE INTERNATIONAL S-AUGPRO

NDA/MAL/HDP/4745 PIPZO

NDA/MAL/HDP/6228 ACINET

NDA/MAL/HDP/2602 CLAVAM BID

NDA/MAL/HDP/3310 GEMFOS

NDA/MAL/HDP/6322 CLAVACE 1000 MG

NDA/MAL/HDP/8248 CLAVACE SUSPENSION

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

ROYAL PHARMA 2011 LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CACHET PHAMACUITICALS PVT LTD

ASTRA PHARMA (U) LIMITED

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CACHET PHARMACEUTICALS PVT LIMITED

VRUSHIK INVESTMENT LIMITED

CACHET PHARMACEUTICALS PVT LIMITED

ASTRA PHARMA (U) LIMITED

Page 48: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8344 CELZA DRY SYRUP

NDA/MAL/HDP/8345 CELZA 500

NDA/MAL/HDP/1345 SWICH-200

NDA/MAL/HDP/1187 GALPHA LABORATORIES LTD AIVEEN (U) LIMITED KEFTAZ-1000

NDA/MAL/HDP/0117 ZOCEF 1.5G

NDA/MAL/HDP/0118 ZOCEF 750MG

NDA/MAL/HDP/1088 GALPHA LABORATORIES LTD AIVEEN (U) LIMITED RESTUM

NDA/MAL/HDP/8087

NDA/MAL/HDP/8088

NDA/MAL/HDP/1632 CLAVAM 1.2G

NDA/MAL/HDP/7491 DENK PHARMA GMBH & CO BENLE CONSULT LIMITED CIPRO-DENK 750

NDA/MAL/HDP/2212 DENK PHARMA BENLE CONSULT LIMITED CIPRO-DENK 500

NDA/MAL/HDP/2698 CADILA HEALTHCARE LTD AZICIN-500

CACHET PHARMACEUTICALS PRIVATE LIMITED

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PRIVATE LIMITED

ASTRA PHARMA (U) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ONDEM INJECTION 4MG/2ML

ALKEM LABORATORIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ONDEM INJECTION 8MG/4ML

: ALKEM LABORATORIES LIMITED√

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 49: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8490 ALTHEA PHARMA PVT LTD. SODIUM CHLORIDE

NDA/MAL/HDP/0866 LIZOLID

NDA/MAL/HDP/4099 GLEVO I.V

NDA/MAL/HDP/7212 PHARMALGAN

NDA/MAL/HDP/1741 NEOPRED-P

NDA/MAL/HDP/1751 OPTIFUCIN

NDA/MAL/HDP/1754 APIMOL

NDA/MAL/HDP/1756 APRICROM

NDA/MAL/HDP/1758 APICORT

NDA/MAL/HDP/1762 APITROPIN

NDA/MAL/HDP/1745 APIGEN

NDA/MAL/HDP/1750 APIFLOX

NDA/MAL/HDP/1760 NEODEX

JOINT MEDICAL STORE (UPMB - UCMB)

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

PHARMACO DISTRIBUTION (PTY) LTD

ECHO PHARMACY (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMMAN PHARMACEUTICAL INDUSTRIES

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 50: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3798 NEUROTON TABLET

NDA/MAL/HDP/1225 MOSEDIN PLUS SR

NDA/MAL/HDP/1227 FUNGISAFE

NDA/MAL/HDP/1176 FUNGISAFE

NDA/MAL/HDP/6191 KAPRON AMPOULE

NDA/MAL/HDP/0186 BBC SPRAY

NDA/MAL/HDP/0192 AMOCOMB CREAM

NDA/MAL/HDP/1638 FLADAZOLE

NDA/MAL/HDP/0187 KAPRON TABLET

NDA/MAL/HDP/1863 ORACURE GEL

NDA/MAL/HDP/3098 MOSEDIN

AMOUN PHARMACEUTICAL COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICAL COMPANY

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICALS COMPANY

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICALS COMPANY

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICALS COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICALS COMPANY

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICAL COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICAL COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICALS COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICAL COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 51: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0227 CYRINOL SYRUP

NDA/MAL/HDP/3459 ENEMAX

NDA/MAL/HDP/3609 ANTINAL

NDA/MAL/HDP/3770 XITHRONE

NDA/MAL/HDP/3778 XITHRONE

NDA/MAL/HDP/3650 ANTINAL

NDA/MAL/HDP/4000 APIDONE SYRUP

NDA/MAL/HDP/8090 RENE PHARMACY LTD GENTAMYCIN INJECTION

NDA/MAL/HDP/0773 RENE PHARMACY LTD ARTEMETHER INJECTION

NDA/MAL/HDP/1448 RENE PHARMACY LTD VITAMIN B INJECTION

NDA/MAL/HDP/5382 RENE PHARMACY LTD DICLOFENAC SODIUM

AMOUM PHARMACEUTICALS LTD

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICALS COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICALS COMPANY

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICALS COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICALS COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

AMOUN PHARMACEUTICALS COMPANY

BOOTS PHARMACEUTICALS LIMITED

AMOUN PHARMACEUTICAL COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

HEBEI NOVASCON TRADING CO. LTD

HEBEI NOVASCON TRADING CO. LTD

HEBEI NOVASCON TRADING CO. LTD

HEBEI NOVASCON TRADING CO. LTD

Page 52: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4017 ZOCIN CAPSULES

NDA/MAL/HDP/2307 ZOCIN SUSPENSION

NDA/MAL/HDP/3076 ARISTO TELVAS 40

NDA/MAL/HDP/1208 VISCO LIQUID

NDA/MAL/HDP/2956 TRANLOK 500

NDA/MAL/HDP/0430 ARISTO ACECLO PLUS

NDA/MAL/HDP/0326 OSTEBON

NDA/MAL/HDP/4528 PIOSAFE MF 15/500

NDA/MAL/HDP/3147 ARISTO TELVAS-H 40/12.5

NDA/MAL/HDP/0593 PANTOP-D

NDA/MAL/HDP/1728 DELISPRIN 75MG

THE ARAB P'CAL MANUFACTIRING CO.

GOODMAN INTERNATIONAL LTD

THE ARAB P'CAL MANUFACTIRING CO.

GOODMAN INTERNATIONAL LTD

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

Page 53: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6772 PIOSAFE 30

NDA/MAL/HDP/6773 ACECLO

NDA/MAL/HDP/3815 QURE 500

NDA/MAL/HDP/4519 S-AMLOSAFE 5

NDA/MAL/HDP/4522 S-AMLOSAFE 2.5

NDA/MAL/HDP/3580 FEXOFEN-120

NDA/MAL/HDP/3588 FEXOFEN-180

NDA/MAL/HDP/0584 TRIGLIMIPREX 1

NDA/MAL/HDP/0589 TRIGLIMIPREX 2

NDA/MAL/HDP/0595 ORNOF

NDA/MAL/HDP/0582 ACECLO SERA

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

Page 54: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1463 ARISTOZYME LIQUID

NDA/MAL/HDP/0429 FLEXON MR

NDA/MAL/HDP/1464 ORNIDA

NDA/MAL/HDP/1042 ARISTO TELVAS-H 80/12.5

NDA/MAL/HDP/2170 ALSARTAN-AM

NDA/MAL/HDP/0460 AMBRODIL

NDA/MAL/HDP/4523 BIGOMET SR 500

NDA/MAL/HDP/2077 AMBRODIL

NDA/MAL/HDP/3070 AMBRODIL

NDA/MAL/HDP/3083 ARISTO TELVAS 80

NDA/MAL/HDP/0600 DENK PHARM GMBH&CO.KG BENLE CONSULT LIMITED CARVEDI-DENK 6.25

ARISTO PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

ARISTO PHARMACEUTICALS PVT LTD

NORVIK ENTERPRISES LIMITED

Page 55: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0605 DENK PHARM GMBH&CO.KG BENLE CONSULT LIMITED CARVEDI-DENK 25

NDA/MAL/HDP/0609 BENLE CONSULT LIMITED CLOPI-DENK 75

NDA/MAL/HDP/2593 E DENK OHG BENLE CONSULT LIMITED ATENOLOL DENK 50

NDA/MAL/HDP/1481 ASTRA PHARMA (U) LIMITED ASTROGYL

NDA/MAL/HDP/1614 ASTAGRA-50

NDA/MAL/HDP/1808 ASTRA PHARMA (U) LIMITED ASTACID

NDA/MAL/HDP/2115 ASTRA PHARMA (U) LIMITED ASTRIM

NDA/MAL/HDP/2962 ASTRA PHARMA (U) LIMITED ASTIDIN

NDA/MAL/HDP/2936 FEMIN-P

NDA/MAL/HDP/3493 ASVIR

NDA/MAL/HDP/3505 ASFLIC

DENK PHARMA GMBH & CO KG

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

Page 56: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3518 ASFLOX

NDA/MAL/HDP/3660 ASTRA PHARMA (U) PVT LTD ASTAGRA

NDA/MAL/HDP/1645 ASTRA PHARMA (U) LIMITED ASTAZOLE

NDA/MAL/HDP/0508 ASTRA PHARMA (U) LIMITED ASTARGAN

NDA/MAL/HDP/3652 BENDAS-400

NDA/MAL/HDP/0025 AMLOAS-5

NDA/MAL/HDP/0026 AMLOAS-10

NDA/MAL/HDP/1346 ASTRA PHARMA LTD ASIX

NDA/MAL/HDP/0385 ASFORMIN

NDA/MAL/HDP/0792 ASTRA PHARMA (U) LIMITED AS-V

NDA/MAL/HDP/0332 ROSUVAX 20

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

Page 57: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0289 ASTRA PHARMA (U) LIMITED TETRAS

NDA/MAL/HDP/3878 ASTRA PHARMA (U) LTD ASTIDIN 400

NDA/MAL/HDP/4021 AZY-500

NDA/MAL/HDP/4295 ASTRAFLAM TABLETS

NDA/MAL/HDP/4571 ASTRA PHARMA (U) LIMITED ASPICLOX

NDA/MAL/HDP/4662 ASDOL

NDA/MAL/HDP/4870 FLUCAS

NDA/MAL/HDP/4873 FLUCAS

NDA/MAL/HDP/4883 ASTRA PHARMA (U) LIMITED ASFEN-FC

NDA/MAL/HDP/4884 ASTRA PHARMA (U) LIMITED ASFULVIN-500

NDA/MAL/HDP/4888 ASTRA PHARMA (U) LIMITED ASOMYCIN

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

Page 58: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5494 ASTRA PHARMA (U) LIMITED ASMOX

NDA/MAL/HDP/2549 AZY-250

NDA/MAL/HDP/2991 LIPOR

NDA/MAL/HDP/3161 ASTRA PHARMA (U) LIMITED ASCILLIN

NDA/MAL/HDP/3345 PAINOL-P

NDA/MAL/HDP/3401 ASTRA PHARMA (U) LIMITED ASCODYL

NDA/MAL/HDP/3570 ASTRA PHARMA (U) LIMITED ASTRIM-960

NDA/MAL/HDP/3675 ASCOPAN

NDA/MAL/HDP/0096 LIPOR

NDA/MAL/HDP/0099 CARBAS

NDA/MAL/HDP/0093 LORAS

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMACY (U) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

Page 59: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0982 ASMETO-10

NDA/MAL/HDP/0169 ROSUVAX 10

NDA/MAL/HDP/1833 ASMOX

NDA/MAL/HDP/2934 ASTRA LIFE CARE PVT LTD ASTOLON

NDA/MAL/HDP/3895 ASNOR

NDA/MAL/HDP/3900 ASTIBA-500

NDA/MAL/HDP/4022 ASTRA PHARMA (U) LIMITED ASPI-M

NDA/MAL/HDP/4881 ASDOXIN

NDA/MAL/HDP/4881 ASDOXIN

NDA/MAL/HDP/1832 DICLOAS

NDA/MAL/HDP/2317 ASTRA PHARMA (U) LIMITED ASMOL

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA UGANDA LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA UGANDA LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

Page 60: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3366 DIAS

NDA/MAL/HDP/2086 BENDAS

NDA/MAL/HDP/3056 ASTRA PHARMA (U) LIMITED ASCAF

NDA/MAL/HDP/3923 AXASONE

NDA/MAL/HDP/3560 DERMIZOL

NDA/MAL/HDP/6509 ASPYROX

NDA/MAL/HDP/6881 ASTRALEVOFLOXA

NDA/MAL/HDP/8283 ASTRA PHARMA (U) LIMITED QUINAS

NDA/MAL/HDP/3921 ASTRA PHARMA (U) PVT LTD AS-B

NDA/MAL/HDP/1228 LUMETHER

NDA/MAL/HDP/0028 HYPERLOK-50

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA UGANDA LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA UGANDA LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFECARE (INDIA) PVT. LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFECARE (INDIA) PVT. LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA LIFECARE (INDIA) PVT. LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

Page 61: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0029 HYPERLOK-100

NDA/MAL/HDP/0900 LAPSONE

NDA/MAL/HDP/0336 AS-DP TABLETS

NDA/MAL/HDP/1010 ASDOPA TABLETS

NDA/MAL/HDP/0330 ASBUTOL-4

NDA/MAL/HDP/2939 ASTODIUM

NDA/MAL/HDP/3911 ASID

NDA/MAL/HDP/4367 ASTRA ZENECA MACNAUGHTON LIMITED ATACAND 8MG

NDA/MAL/HDP/4411 ASTRA ZENECA MACNAUGHTON LIMITED ATACAND PLUS

NDA/MAL/HDP/5143 ASTRA ZENECA MACNAUGHTON LIMITED BETALOC ZOK - 25MG

NDA/MAL/HDP/5147 ASTRA ZENECA MACNAUGHTON LIMITED BETALOC ZOK - 50MG

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA LIFE CARE (INDIA) PVT LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA UGANDA LTD

ASTRA PHARMA (U) LIMITED

Page 62: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1211 ASTRA ZENECA MACNAUGHTON LIMITED BRILINTA

NDA/MAL/HDP/5146 ASTRA ZENECA MACNAUGHTON LIMITED BETALOC ZOK - 100MG

NDA/MAL/HDP/5496 ASTRA ZENECA MACNAUGHTON LIMITED ATACAND 16MG

NDA/MAL/HDP/2353 ASTRA ZENECA MACNAUGHTON LIMITED NEXIUM

NDA/MAL/HDP/2233 ASTRAZENECA MACNAUGHTON LIMITED PULMICORT NEBULISER

NDA/MAL/HDP/2705 ASTRAZENECA MACNAUGHTON LIMITED PULMICORT NEBULISER

NDA/MAL/HDP/1415 ASTRA ZENECA MACNAUGHTON LIMITED ATACAND

NDA/MAL/HDP/1392 ASTRA ZENECA MACNAUGHTON LIMITED ZOLADEX

NDA/MAL/HDP/1931 ASTRAZENECA MACNAUGHTON LIMITED ZOLADEX LA

NDA/MAL/HDP/5363 ASTRA ZENECA MACNAUGHTON LIMITED CASODEX 50MG

NDA/MAL/HDP/0946 ASTRAZENECA MACNAUGHTON LIMITED TENORETIC

Page 63: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1828 ASTRAZENECA MACNAUGHTON LIMITED TENORET

NDA/MAL/HDP/2772 ASTRAZENECA MACNAUGHTON LIMITED TENORMIN

NDA/MAL/HDP/3376 ASTRAZENECA MACNAUGHTON LIMITED TENORMIN

NDA/MAL/HDP/1395 ASTRA ZENECA AB MACNAUGHTON LIMITED NEXIUM 40MG IV

NDA/MAL/HDP/0858 ASTRAZENECA MACNAUGHTON LIMITED PLENDIL

NDA/MAL/HDP/1397 ASTRAZENECA MACNAUGHTON LIMITED PLENDIL

NDA/MAL/HDP/1793 MACNAUNGHTON LIMITED MACNAUGHTON LIMITED SYMBICORT TURBUHALER

NDA/MAL/HDP/2350 ASTRA ZENECA AB MACNAUGHTON LIMITED PULMICORT TURBUHALER

NDA/MAL/HDP/2615 ASTRA ZENECA AB MACNAUGHTON LIMITED SYMBICORT TURBUHALER

NDA/MAL/HDP/0360 ASTRA ZENECA AB MACNAUGHTON LIMITED NEXIUM 20MG

NDA/MAL/HDP/1803 ASTRA ZENECA AB MACNAUGHTON LIMITED NEXIUM 40MG

Page 64: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1452 ASTRA ZENECA MACNAUGHTON LIMITED ZESTORETIC

NDA/MAL/HDP/5362 ASTRA ZENECA MACNAUGHTON LIMITED CASODEX 150MG

NDA/MAL/HDP/0418 ASTRA ZENECA MACNAUGHTON LIMITED KOMBIGLYZE XR 5MG/1000

NDA/MAL/HDP/0419 ASTRAZENECA MACNAUGHTON LIMITED

NDA/MAL/HDP/1575 ASTRAZENECA MACNAUGHTON LIMITED ZESTRIL

NDA/MAL/HDP/1576 ASTRAZENECA MACNAUGHTON LIMITED ZESTRIL

NDA/MAL/HDP/4360 ASTRAZENECA MACNAUGHTON LIMITED ZESTRIL

NDA/MAL/HDP/1781 ASTRAZENECA MACNAUGHTON LIMITED ARIMIDEX

NDA/MAL/HDP/4190 ASTRAZENECA MACNAUGHTON LIMITED NOLVADEX

NDA/MAL/HDP/4943 ASTRAZENECA MACNAUGHTON LIMITED NOLVADEX

NDA/MAL/HDP/3867 ROYAL GROUP BETADERM OINTMENT

KOMBIGLYZE XR 2.5MG/1000MG

ABACUS PHARMA (AFRICA) LIMITED

Page 65: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2502 ROYAL GROUP PROBETA N EYE DROP

NDA/MAL/HDP/2979 ROYAL GROUP BETADERM N CREAM

NDA/MAL/HDP/3177 ROYAL GROUP BETADERM CREAM

NDA/MAL/HDP/5287 AUROBINDO PHARMA LTD

NDA/MAL/HDP/6299 AUROBINDO PHARMA LTD OLANGEM 5

NDA/MAL/HDP/6301 AUROBINDO PHARMA LTD OLANGEM 10

NDA/MAL/HDP/6457 AUROBINDO PHARMA LTD MOXIWAR 400

NDA/MAL/HDP/6470 AUROBINDO PHARMA LTD MF-DAY 1000

NDA/MAL/HDP/6630 AUROBINDO PHARMA LTD TOPRAZ 20

NDA/MAL/HDP/8189 AUROBINDO PHARMA LTD

NDA/MAL/HDP/0071 AUROBINDO PHARMA LTD SUMAFIX 100

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

ABACAVIR SULPHATE TABLETS

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 66: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3731 AUROBINDO PHARMA LTD EFAVIRENZ 50MG

NDA/MAL/HDP/5275 AUROBINDO PHARMA LTD EFAVIRENZ

NDA/MAL/HDP/1937 AUROBINDO PHARMA LTD EFAVIRENZ

NDA/MAL/HDP/8159 LOPINAVIR + RITONAVIR

NDA/MAL/HDP/2938 AUROBINDO PHARMA LTD CLOXIL-250 CAPSULES

NDA/MAL/HDP/7828 DIZTROL 24

NDA/MAL/HDP/0213 AUROPODOX 200

NDA/MAL/HDP/2337 AUROBINDO PHARMA LTD AUROXETIL-500

NDA/MAL/HDP/2582 AUROXETIL-250

NDA/MAL/HDP/3543 AUROBINDO PHARMA LTD DROX 250

NDA/MAL/HDP/3593 AUROBINDO PHARMA LTD DROX 500

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AUROBINDO PHARMA LIMITED (UNIT III)

GITTOES PHARMACEUTICALS LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROBINDO PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROBINDO PHARMA LTD (UNIT VI)

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROBINDOM PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 67: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1112 AUROBINDO PHARMA LTD ZIDOVUDINE CAPSULES

NDA/MAL/HDP/4686

NDA/MAL/HDP/4397 AUROBINDO PHARMA LTD BISODAC-HF 2.5

NDA/MAL/HDP/4446 AUROBINDO PHARMA LTD HI-ALFA 2.5

NDA/MAL/HDP/5224 AUROBINDO PHARMA LTD

NDA/MAL/HDP/8190 AUROBINDO PHARMA LTD LAMIVUDINE TABLETS

NDA/MAL/HDP/0331 LEVOKILZ 500

NDA/MAL/HDP/4410 M-KAST 4

NDA/MAL/HDP/4412 M-KAST 5

NDA/MAL/HDP/3908 AUROBINDO PHARMA ZIDOVUDINE

NDA/MAL/HDP/3912 AUROBINDO PHARMA LTD

GITTOES PHARMACEUTICALS LIMITED

AUROBINDOM PHARMA LIMITED

GITTOES PHARMACEUTICALS LIMITED

ZIDOVUDINE ORAL SOLUTION USP

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE

GITTOES PHARMACEUTICALS LIMITED

AUROBINDO PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROBINDO PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROBINDO PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE

Page 68: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5281 AUROBINDO PHARMA LTD

NDA/MAL/HDP/8188 AUROBINDO PHARMA LTD

NDA/MAL/HDP/4039 AUROBINDO PHARMA LTD EFAVIRENZ

NDA/MAL/HDP/4175 AUROBINDO PHARMA LTD KOACT 156.25

NDA/MAL/HDP/2339 AUROBINDO PHARMA LTD KOACT-375

NDA/MAL/HDP/2342 AUROBINDO PHARMA LTD KOACT-625

NDA/MAL/HDP/2703 AUROBINDO PHARMA LTD KOACT 312.50

NDA/MAL/HDP/1631 AUROBINDO PHARMA LTD

NDA/MAL/HDP/2346 AUROBINDO PHARMA LTD

NDA/MAL/HDP/3322 AUROBINDO PHARMA LTD NEVIRAPINE

NDA/MAL/HDP/3397 AUROBINDO PHARMA LTD

GITTOES PHARMACEUTICALS LIMITED

EFAVIRENZ+EMTRICITABINE+TENOFOVIR DISOPROXIL

GITTOES PHARMACEUTICALS LIMITED

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

GITTOES PHARMACEUTICALS LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

NEVIRAPINE ORAL SUSPENSION

GITTOES PHARMACEUTICALS LIMITED

ABACAVIR SULFATE ORAL SOLUTION

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

TENOFOVIR DISOPROXIL FUMARATE

Page 69: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4068

NDA/MAL/HDP/4570 AUROBINDO PHARMA LTD NEVIRAPINE

NDA/MAL/HDP/5369 AUROBINDO PHARMA LTD LAMIVUDINE

NDA/MAL/HDP/5431 AUROBINDO PHARMA LTD ZIDOVUDINE

NDA/MAL/HDP/2132 AUROBINDO PHARMA LTD LOPINAVIR/ RITONAVIR

NDA/MAL/HDP/2327 AUROBINDO PHARMA LTD ABACAVIR SULPHATE

NDA/MAL/HDP/3127 AUROBINDO PHARMA LTD

NDA/MAL/HDP/8191 AUROBINDO PHARMA LTD

NDA/MAL/HDP/3941 AUROBINDO PHARMA LTD AUROZIL 500

NDA/MAL/HDP/3942 AUROBINDO PHARMA LTD AUROZIL 250

NDA/MAL/HDP/1125 AUROBINDO PHARMA LTD AUROXONE 1000

AUROBINDO PHARMA LIMITED

GITTOES PHARMACEUTICALS LIMITED

LAMIVUDINE/ZIDOVUDINE/EFAVIRENZ

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

DIDANOSINE DELAYED - RELEAS

GITTOES PHARMACEUTICALS LIMITED

DIDANOSINE DELAYED-RELEASE

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 70: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1037 AUROBINDO PHARMA LTD LAMIVUDINE + TENOFOVIR

NDA/MAL/HDP/0004 AUROBINDO PHARMA LTD INRAB 20

NDA/MAL/HDP/1868 AUROBINDO PHARMA LTD ZIDOVUDINE

NDA/MAL/HDP/8355 ONECLAPZ 75

NDA/MAL/HDP/8476 AURODANZ 8

NDA/MAL/HDP/5376 AUROBINDO PHARMA LTD

NDA/MAL/HDP/4468 AUROBINDO PHARMA LTD TOPRAZ 40

NDA/MAL/HDP/7373 SUPER MEDIC LTD FUSIGO CREAM

NDA/MAL/HDP/7374 SUPER MEDIC LTD FUSIGO-HC CREAM

NDA/MAL/HDP/7450 SUPER MEDIC LTD DOLOACT GEL

GITTOES PHARMACEUTICALS LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

AUROBINDOM PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROBINDO PHARMA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

LAMIVUDINE & ZIDOVUDINE

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AUROCHEM LABORATORIES(INDIA) PVT LTD

AUROCHEM LABORATORIES(INDIA) PVT LTD

AUROCHEM LABORATORIES(INDIA) PVT LTD

Page 71: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7482 SUPER MEDIC LTD FUSIGO-B CREAM

NDA/MAL/HDP/7589 SUPER MEDIC LTD LACX SYRUP

NDA/MAL/HDP/8243 SUPER MEDIC LTD

NDA/MAL/HDP/7452 SUPER MEDIC LTD XTRADERM CREAM

NDA/MAL/HDP/7586 SUPER MEDIC LTD CLEAR-T GEL

NDA/MAL/HDP/7365 SUPER MEDIC LTD DOLOACT MR

NDA/MAL/HDP/0594 AUROLAB AUROVISC-2ML PFS

NDA/MAL/HDP/6062 AUROLAB OFPRED

NDA/MAL/HDP/6223 AUROLAB AUROPROST- RT

NDA/MAL/HDP/0592 AUROLAB AUROCHROME

NDA/MAL/HDP/1341 AUROLAB G-FLOX

AUROCHEM LABORATORIES(INDIA) PVT LTD

AUROCHEM LABORATORIES(INDIA) PVT LTD

AUROCHEM LABORATORIES(INDIA) PVT LTD

TRANEXAMIC ACID + MEFENAMIC ACID

AUROCHEM LABORATORIES(INDIA) PVT LTD

AUROCHEM LABORATORIES(INDIA) PVT LTD

AUROCHEM PHAMACEAUTICALS (1) LTD)

SWASTIK PHARMACEUTICAL LTD

SWASTIK PHARMACEUTICAL LTD

SWASTIK PHARMACEUTICAL LTD

SWASTIK PHARMACEUTICAL LTD

SWASTIK PHARMACEUTICAL LTD

Page 72: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0588 AUROLAB AUROFORT

NDA/MAL/HDP/4390 AUROLAB AUROCOL

NDA/MAL/HDP/4279 AUROLAB AUROTIM

NDA/MAL/HDP/0753 AUROBINDO PHARMA LTD MEROGRAM 500

NDA/MAL/HDP/7378 ERTAPIK

NDA/MAL/HDP/8500 INEMPLUS 500

NDA/MAL/HDP/0749 AUROBINDO PHARMA LTD MEROGRAM 1000

NDA/MAL/HDP/4909 AXA PARENTERALS LTD AXAGYL

NDA/MAL/HDP/2114 AXA PARENTERALS LTD AXA-LEVO

NDA/MAL/HDP/6512 AXA PARENTERALS LTD AXACIP

NDA/MAL/HDP/7446 AXA PARENTERALS LTD CIPLUME

SWASTIK PHARMACEUTICAL LTD

SWASTIK PHARMACEUTICAL LTD

SWASTIK PHARMACEUTICAL LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AURONEXT PHARMA PRIVATE LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

AURONEXT PHARMA PRIVATE LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 73: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7906 AXA PARENTERALS LTD IVMOL

NDA/MAL/HDP/8245 AXA PARENTERALS LTD

NDA/MAL/HDP/0514 MANKIND PHARM LTD TATA UGANDA LIMITED CEFAKIND-500

NDA/MAL/HDP/0519 MANKIND PHARM LTD TATA UGANDA LIMITED CEFAKIND-250

NDA/MAL/HDP/3148 BAYER AG ALKA-SELTZER

NDA/MAL/HDP/2167 BAYER AG MYCOSPOR SOLUTION

NDA/MAL/HDP/3714 BAYER EAST AFRICA LTD ADALAT LA

NDA/MAL/HDP/8007 BAYER AG ADALAT RETARD

NDA/MAL/HDP/1487 BAYER PHARMA AG

NDA/MAL/HDP/4755 BAYER SCHERING AG ADVANTAN CREAM

NDA/MAL/HDP/2943 SCHERING N.V.SA... SCHERIPROCT OINTMENT

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

MOXIFLOXACIN HYDROCHLORIDE

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SCHERIPROCT SUPPOSITORIES

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 74: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2993 SCHERING N.V.SA... TRAVOCORT

NDA/MAL/HDP/6690 SCHERING N.V.SA... ADVANTAN OINTMENT

NDA/MAL/HDP/6740 SCHERING N.V.SA... TRAVOGEN CREAM

NDA/MAL/HDP/0175 BAYER SCHERING PHARMA XARELTO 10MG

NDA/MAL/HDP/1529 BAYER PHARMA AG PROVIRON

NDA/MAL/HDP/1433 BAYER PHARMA AG NORISTERAT

NDA/MAL/HDP/1491 BAYER PHARMA AG BILTRICIDE TABLETS

NDA/MAL/HDP/3768 BAYER PHARMA AG NIMOTOP 30MG

NDA/MAL/HDP/3789 BAYER PHARMA AG LEVITRA

NDA/MAL/HDP/3802 BAYER PHARMA AG LEVITRA 10MG

NDA/MAL/HDP/3846 BAYER PHARMA AG LEVITRA

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 75: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4750 BAYER AG CIPROBAY I.V

NDA/MAL/HDP/4753 BAYER AG CIPROBAY 750

NDA/MAL/HDP/4754 BAYER PHARMA CIPROBAY XR

NDA/MAL/HDP/5469 BAYER PHARMA AG NIMOTOP

NDA/MAL/HDP/2063 BAYER PHARMA AG MICROGYNON FE

NDA/MAL/HDP/2149 BAYER PHARMA AG PRIMOLUT DEPOT

NDA/MAL/HDP/2219 BAYER PHARMA AG PRIMOLUT N

NDA/MAL/HDP/3568 BAYER PHARMA AG MYCOSPOR CREAM

NDA/MAL/HDP/0748 BAYER PHARMA XARELTO 15MG

NDA/MAL/HDP/0750 BAYER PHARMA XARELTO 20MG

NDA/MAL/HDP/5634 BAYER AG CIPROBAY

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 76: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8142 BAYER EAST AFRICA LTD XARELTO

NDA/MAL/HDP/5021 COMBINATION 3

NDA/MAL/HDP/0411 BAYER PHARMA AG JADELLA SINE

NDA/MAL/HDP/2070 BAYER PHARMA AG MIRENA

NDA/MAL/HDP/2306 BAYER PHARMA AG MICROLUT

NDA/MAL/HDP/3901 MICROGYNON ED FE

NDA/MAL/HDP/2330 NOVARTIS PHARMA AG COARTEM

NDA/MAL/HDP/5342 BELL'S MUSCLE RUB

NDA/MAL/HDP/3495

NDA/MAL/HDP/6625 NEBILET PLUS 5/12.5

SURGIPHARM (U) LIMITED

BAYER SCHERING PHARMA FRANCE

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

BAYER SCHERING PHARMA FRANCE

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

BELL SONS & CO.(DRUGGISTS) LTD

ECHO PHARMACY (U) LIMITED

BELL SONS & CO.(DRUGGISTS) LTD

ECHO PHARMACY (U) LIMITED

MENTHODEX COUGH MIXTURE

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 77: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6620 NEBILET 5MG

NDA/MAL/HDP/4965 BETAFEN SYRUP

NDA/MAL/HDP/8211 MUCO-ASTHALIN SYRUP

NDA/MAL/HDP/5134

NDA/MAL/HDP/5134

NDA/MAL/HDP/6756

NDA/MAL/HDP/5136

NDA/MAL/HDP/5154 BETASIL PAEDIATRIC SYRUP

NDA/MAL/HDP/5154 BETASIL PAEDIATRIC SYRUP

NDA/MAL/HDP/1839 FEVEREX

NDA/MAL/HDP/1413 PODINE MOUTH WASH

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

SHELYS PHARMACEUTICALS LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

GOODMORNING COUGH TABLETS

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

GOODMORNING COUGH TABLETS

BETA HEALTH CARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

FEVERIX TOTO SUSPENSION

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

GOODMORNING LUNG TONIC

BETA HEALTH CARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTH CARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

Page 78: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2509 OPELE LOTION

NDA/MAL/HDP/0492 KIMSY MEDS LTD ZOLFIN

NDA/MAL/HDP/0466 KIMSY MEDS LTD ALPHIN DS

NDA/MAL/HDP/0462 KIMSY MEDS LTD DECOMIT 50 HFA

NDA/MAL/HDP/0465 KIMSY MEDS LTD DECOMIT 100 HFA

NDA/MAL/HDP/0498 KIMSY MEDS LTD EVO 500

NDA/MAL/HDP/0494 KIMSY MEDS LTD INFORMET 500

NDA/MAL/HDP/0461 KIMSY MEDS LTD BEXITROL-F HFA 25/125

NDA/MAL/HDP/5485 KIMSY MEDS LTD AZMASOL HFA

NDA/MAL/HDP/4092 FLORANORM

NDA/MAL/HDP/7907 HUCOG 5000 HP

NDA/MAL/HDP/7090 ENDOPROST

NDA/MAL/HDP/1571 RHOCLONE

BETA HEALTH CARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BEXIMCO PHARMACEUTICALS LTD

BEXIMCO PHARMACEUTICALS LTD

BEXIMCO PHARMACEUTICALS LTD

BEXIMCO PHARMACEUTICALS LTD

BEXIMCO PHARMACEUTICALS LTDBEXIMCO PHARMACEUTICALS LIMITED

BEXIMCO PHARMACEUTICALS LTD

BEXIMCO PHARMACEUTICALS LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LTD

BHARAT SERUMS AND VACCINES LTD

GITTOES PHARMACEUTICALS LIMITED

Page 79: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0590 ASNA ANTIVENOM C

NDA/MAL/HDP/0570 TETGLOB 250 I.U

NDA/MAL/HDP/0553 EQUIRAB

NDA/MAL/HDP/4404 FOLIGRAF

NDA/MAL/HDP/6040 U-TRYP

NDA/MAL/HDP/6137 LUPRODEX

NDA/MAL/HDP/3711 POLY-MXB

NDA/MAL/HDP/2696 AMPHOTRET

NDA/MAL/HDP/8162 TATA UGANDA LIMITED HUMOG 75 HP

NDA/MAL/HDP/8043 DAFRA PHARMA GMBH RABEZOL

NDA/MAL/HDP/4611 DAFRA PHARMA LTD DAFRACLAV

NDA/MAL/HDP/4820 IDA KIMSY MEDS LTD

NDA/MAL/HDP/4824 MISSION PHARMA A/S

NDA/MAL/HDP/1026 BIOCON LTD INSUGEN R (REGULAR)

BHARAT SERUMS AND VACCINES LTD

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LTD

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LTD

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

BHARAT SERUMS AND VACCINES LTD

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITED

FERROUS SULPHATE+FOLIC ACID

JOINT MEDICAL STORE (UPMB - UCMB)

FERROUS SULPHATE+FOLIC ACID

ABACUS PHARMA (AFRICA) LIMITED

Page 80: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1027 BIOCON LTD INSUGEN-N (NPH)

NDA/MAL/HDP/1028 BIOCON LTD

NDA/MAL/HDP/0487 BIOCON LTD BASALOG

NDA/MAL/HDP/0481 BIOCON LTD ERYPRO SAFE 4000

NDA/MAL/HDP/6145 KIMSY MEDS LTD ENDULIN SELECT

NDA/MAL/HDP/6147 KIMSY MEDS LTD ENDULIN VAIL

NDA/MAL/HDP/6047 KIMSY MEDS LTD HERTRAZ 150

NDA/MAL/HDP/8244 KIMSY MEDS LTD HERTRAZ 440

NDA/MAL/HDP/0271 BIOLOGICAL E. LTD BETT

NDA/MAL/HDP/0271 BIOLOGICAL E. LTD

NDA/MAL/HDP/0271 BIOLOGICAL E. LTD

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

INSUGEN -30/70 (BIPHASIC)

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

TETANUS VACCINE ADSORBED

GITTOES PHARMACEUTICALS LIMITED

TETANUS VACCINE ADSORBED

Page 81: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2083 BIOLOGICAL E. LTD BEVAC

NDA/MAL/HDP/6245 BIOLOGICAL E. LTD COSCOPIN LINCTUS

NDA/MAL/HDP/8156 TATA (U) LTD

NDA/MAL/HDP/0367 BG-ZOLE -400

NDA/MAL/HDP/1220 BLISS GVS PHARMA LIMITED LONART

NDA/MAL/HDP/0363 BLISS GVS PHARMA LIMITED AGYCIN

NDA/MAL/HDP/0366 BLISS GVS PHARMA LIMITED AGYCIN 500

NDA/MAL/HDP/1065 BLISS GVS PHARMA LIMITED SLIPIZEM-5

NDA/MAL/HDP/1312 SLIPIZEM- 2.5

NDA/MAL/HDP/1260 BLISS GVS PHARMA LIMITED DIABETA

NDA/MAL/HDP/0663 BLISS GVS PHARMA LIMITED GLYCERIN

NDA/MAL/HDP/1215 BLISS GVS PHARMA LIMITED

GITTOES PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

GYNANFORT VAGINAL PESSARY

Page 82: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3982 BLISS GVS PHARMA LIMITED LONART SUPPOSITORY

NDA/MAL/HDP/2907 BLISS GVS PHARMA LIMITED LONART

NDA/MAL/HDP/2951 LONART FORTE TABLETS

NDA/MAL/HDP/2980 BLISS GVS PHARMA LIMITED LONART TABLETS

NDA/MAL/HDP/3528 LONART-DISPERSABLE

NDA/MAL/HDP/3123 BLISS GVS PHARMA LIMITED RECTOL 250 SUPPOSITORY

NDA/MAL/HDP/3736 PHARMAVET LTD RECTOL 125 SUPPOSITORY

NDA/MAL/HDP/0662 PHARMAVET LTD RECTIN 100

NDA/MAL/HDP/3803 BLISS GVS PHARMA LIMITED DICLODYNE SUPPOSITORY

NDA/MAL/HDP/4839 PHARMAVET LTD ANOMEX

NDA/MAL/HDP/5169 BLISS GVS PHARMA LIMITED GVGYL SUPPOSITORY

NDA/MAL/HDP/6176 BLISS GVS PHARMA LIMITED G-GLUTAMIN PLUS

NDA/MAL/HDP/1925 G - ALFENAC- P

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

Page 83: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2390 BLISS GVS PHARMA LIMITED P-ALAXIN

NDA/MAL/HDP/2450 BLISS GVS PHARMA LIMITED TODAY PESSARY

NDA/MAL/HDP/2809 BLISS GVS PHARMA LIMITED MAITRI

NDA/MAL/HDP/3340 BLISS GVS PHARMA LIMITED POVED

NDA/MAL/HDP/3600 BLISS GVS PHARMA LIMITED P-ALAXIN TABLETS

NDA/MAL/HDP/8637 AGYCIN

NDA/MAL/HDP/1218 BLISS GVS PHARMA LIMITED GSUNATE-50

NDA/MAL/HDP/1552

NDA/MAL/HDP/1806 BLUMOX P

NDA/MAL/HDP/2617

NDA/MAL/HDP/6679 WOMIBAN TABLETS

NDA/MAL/HDP/4715 MEFTAL FORTE

NDA/MAL/HDP/4717 MEFTAL-SPAS

NDA/MAL/HDP/1821 MEFTAL 500 TABLETS

NDA/MAL/HDP/2653 SONADERM-GM

NDA/MAL/HDP/3385 MEFTAL-P-SUSPENSION

NDA/MAL/HDP/8443 EKON-D TABLETS

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

BLISS GVS PHARMA LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

BLUE CROSS LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUDROX TABLETS, DISPERSIBLE

BLUE CROSS LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUE CROSS LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUDROX TABLETS DISPERSABLE

BLUE CROSS LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUE CROSS LABARATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUE CROSS LABARATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUE CROSS LABORATORIES LTD

STAR PHARMACEUTICALS LTD

BLUE CROSS LABORATORIES LTD

STAR PHARMACEUTICALS LTD

BLUE CROSS LABORATORIES LTD

STAR PHARMACEUTICALS LTD

BLUE CROSS LABORATORIES LTD

STAR PHARMACEUTICALS LTD

Page 84: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6678 TUSQ-DX

NDA/MAL/HDP/6753 TUSQ X SYRUP

NDA/MAL/HDP/2852 LEK-500

NDA/MAL/HDP/6431 BRAWN LABORATORIES LTD HEALTHCARE LTD. BRUMOX 125

NDA/MAL/HDP/6433 BRAWN LABORATORIES LTD HEALTHCARE LTD. FICYC CREAM

NDA/MAL/HDP/6435 BRAWN LABORATORIES LTD HEALTHCARE LTD. FIMABUTE 200

NDA/MAL/HDP/6447 BRAWN LABORATORIES LTD HEALTHCARE LTD. AZIBRU 500

NDA/MAL/HDP/6455 BRAWN LABORATORIES LTD HEALTHCARE LTD. FICYC TABLETS

NDA/MAL/HDP/6857 BRAWN LABORATORIES LTD HEALTHCARE LTD. BRUCIPRO TABLETS

NDA/MAL/HDP/6862 BRAWN LABORATORIES LTD HEALTHCARE LTD. DITS GEL

NDA/MAL/HDP/6865 BRAWN LABORATORIES LTD HEALTHCARE LTD. DITS INJECTION

NDA/MAL/HDP/6870 BRAWN LABORATORIES LTD HEALTHCARE LTD. HYDROSONE 100MG

NDA/MAL/HDP/6872 BRAWN LABORATORIES LTD HEALTHCARE LTD.

NDA/MAL/HDP/6874 BRAWN LABORATORIES LTD HEALTHCARE LTD. CEZIN TABLETS

NDA/MAL/HDP/6875 BRAWN LABORATORIES LTD HEALTHCARE LTD. BRUMOX-250 CAPSULES

NDA/MAL/HDP/8206 BRAWN LABORATORIES LTD HEALTHCARE LTD. BRULEXIN

NDA/MAL/HDP/0892 ASTRA ZENECA MACNAUGHTON LIMITED ONGLYZA

BLUE CROSS LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUE CROSS LABARATORIES LIMITED

STAR PHARMACEUTICALS LTD

BLUE CROSS LABORATORIES LTD

STAR PHARMACEUTICALS LTD

NETRACORTIL EYE/EAR SUSPENSION

Page 85: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6218 ASTRA ZENECA MACNAUGHTON LIMITED FORXIGA

NDA/MAL/HDP/0904 ASTRA ZENECA MACNAUGHTON LIMITED ONGLYZA

NDA/MAL/HDP/8324 LOOBID TABLETS

NDA/MAL/HDP/6230 EMITINO

NDA/MAL/HDP/6700 ARTIMED

NDA/MAL/HDP/6703 CACHCOLD PLUS

NDA/MAL/HDP/6704 CACHET

NDA/MAL/HDP/6705 CACHEWORM

NDA/MAL/HDP/6706 CACH-E-WORM

NDA/MAL/HDP/6707 CACHFER

NDA/MAL/HDP/6711 CACHPAR

NDA/MAL/HDP/6712 CACID-O

NDA/MAL/HDP/6713 CAMET

NDA/MAL/HDP/6715 CAZITHRO

NDA/MAL/HDP/6717 CAZITHRO

NDA/MAL/HDP/6718 CETPRO

CACHET PHARMACEUTICALS PRIVATE LIMITED

ASTRA PHARMA (U) LIMITED

CACHET PHAMACUITICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHAMACUITICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

Page 86: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6734 EASCOF

NDA/MAL/HDP/6765 IBUCACH 200

NDA/MAL/HDP/6793 NEST

NDA/MAL/HDP/7357 PAMAGIN-C SYRUP

NDA/MAL/HDP/8264 CACHET PHARMA PVT LTD EMITINO ORAL SOLUTION

NDA/MAL/HDP/4545 CACH-ART 20/120

NDA/MAL/HDP/6244 CABALIN

NDA/MAL/HDP/6701 CACH-ART DS

NDA/MAL/HDP/6709 CACHPAR

NDA/MAL/HDP/7105 TRAMACETAL TABLETS

NDA/MAL/HDP/8644 LOOBID SUSPENSION

NDA/MAL/HDP/8665 PAMAGIN-C

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

VRUSHIK INVESTMENT LIMITED

ASTRA PHARMA (U) LIMITED

CACHET PHAMACUITICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHAMACUITICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LIMITED

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

CACHET PHARMACEUTICALS PVT LTD

VRUSHIK INVESTMENT LIMITED

Page 87: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6737 ESENVIT

NDA/MAL/HDP/0780 CADILA HEALTHCARE LTD ATORVA TABLETS

NDA/MAL/HDP/1148 CADILA HEALTHCARE LTD ODIMONT

NDA/MAL/HDP/0937 VALAZYD H 92.5

NDA/MAL/HDP/4067 CATENOL-50 TABLETS

NDA/MAL/HDP/4170 CADILA HEALTHCARE LTD TRAMAZAC

NDA/MAL/HDP/4594 CADILA HEALTHCARE LTD TINIBA-500 TABLETS

NDA/MAL/HDP/5148 CADILA HEALTHCARE LTD BETANASE TABLETS

NDA/MAL/HDP/5405 CADILA HEALTHCARE LTD OLANDUS

NDA/MAL/HDP/1929 CADILA HEALTHCARE LTD ARTORVA 40

NDA/MAL/HDP/2816 CATENOL-100 TABLETS

NDA/MAL/HDP/3105 DEPIN-E RETARD

CACHET PHARMACEUTICALS PVT LTD

ASTRA PHARMA (U) LIMITED

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 88: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3569 CARBADAC-200

NDA/MAL/HDP/2567 CIPROBID-500

NDA/MAL/HDP/1681 CADILA HEALTHCARE LTD LOSACAR 25

NDA/MAL/HDP/2868 CADILA HEALTHCARE LTD LOSACAR 50

NDA/MAL/HDP/2941 CADILA HEALTHCARE LTD ATORVA 20

NDA/MAL/HDP/4169 CADILA HEALTHCARE LTD FLUCOZYD-200

NDA/MAL/HDP/5074 CADILA HEALTH CARE LTD DEXONA INJECTION

NDA/MAL/HDP/5075 CADILA HEALTHCARE LTD DEXONA TABLETS

NDA/MAL/HDP/0400 IBSOL 1.2

NDA/MAL/HDP/1297 OLMY 40

NDA/MAL/HDP/4364 VOMIZ OD 8

NDA/MAL/HDP/1908 CADILA HEALTHCARE LTD OLMY 20

NDA/MAL/HDP/2220 CADILA HEALTHCARE LTD AMLODAC 5

NDA/MAL/HDP/2879 CADILA HEALTHCARE LTD OFLIN-200

NDA/MAL/HDP/3044 CADILA HEALTHCARE LTD PIRICAM-20 CAPSULES

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTHCARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 89: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3249 CADILA HEALTHCARE LTD LOSACAR-H

NDA/MAL/HDP/0245 CADILA HEALTHCARE LTD EUGLIM 4

NDA/MAL/HDP/4132 ZYCEL

NDA/MAL/HDP/3356 ZYCEL-100 CAPSULES

NDA/MAL/HDP/2377 R-LOCK TABLETS

NDA/MAL/HDP/8233 CADILA HEALTHCARE LTD COLSTIM

NDA/MAL/HDP/0733 ZYNAC

NDA/MAL/HDP/1147 CADILA HEALTHCARE LTD VALAZYD

NDA/MAL/HDP/3739 CADILA HEALTH CARE LTD ALDREN

NDA/MAL/HDP/3743 CADILA HEALTH CARE LTD CARVIL 3.125

NDA/MAL/HDP/0630 NEO LORIDIN

NDA/MAL/HDP/0823 TRAP TABLETS

NDA/MAL/HDP/2467 CADILA HEALTHCARE LTD NOKLOT

NDA/MAL/HDP/2702 EUGLIM 2

NDA/MAL/HDP/3015 CADILA HEALTHCARE LTD PENEGRA-50 TABLETS

NDA/MAL/HDP/3663 CADILA HEALTHCARE LTD AMLODAC 10

NDA/MAL/HDP/3704 CADILA HEALTHCARE LTD PENEGRA 100

NDA/MAL/HDP/0756 TOLFREE 100

NDA/MAL/HDP/0757 TOLFREE 150

NDA/MAL/HDP/2183 CADILA HEALTHCARE LTD OCID I.V.

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITED

Page 90: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2699 CADILA HEALTHCARE LTD CARVIL 12.5

NDA/MAL/HDP/4621 CARVIL 6.25

NDA/MAL/HDP/1468 CADILA HEALTHCARE LTD OCID CAPSULES

NDA/MAL/HDP/1519 CADILA HEALTHCARE LTD FORMONIDE 400

NDA/MAL/HDP/0700 CADILA HEALTHCARE LTD VAXIRAB N

NDA/MAL/HDP/5051 DERIHALER

NDA/MAL/HDP/2187 VOMIZ

NDA/MAL/HDP/2431 FORMONIDE 200

NDA/MAL/HDP/2432 CADILA HEALTH CARE LTD FORMONIDE 100

NDA/MAL/HDP/2565 CADILA HEALTHCARE LTD TRAMAZAC INJECTION

NDA/MAL/HDP/2919 CADILA HEALTHCARE LTD ODIMONT 5

NDA/MAL/HDP/8641 TELI H

NDA/MAL/HDP/0988 CADITOR 20

NDA/MAL/HDP/0984 CADILA PHARMACEUTICALS JOVAN T20

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTHCARE LIMITED SARKHEJ

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

Page 91: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2071 CEFAMOR DRY SYRUP

NDA/MAL/HDP/2751 CADILA PHARMACEUTICALS FLUDAC CAPSULES

NDA/MAL/HDP/7342 CADILA PHARMACEUTICALS ZEALARGY

NDA/MAL/HDP/2093 TRIGAN-D TABLET

NDA/MAL/HDP/5233 ENVAS 10 MG TABLETS

NDA/MAL/HDP/5234 ENVAS 5MG TABLETS

NDA/MAL/HDP/8312 CADILA PHARMACEUTICALS TRICORT 40

NDA/MAL/HDP/1635

NDA/MAL/HDP/1445 AXONE 1000

NDA/MAL/HDP/0585 CADILA PHARMACEUTICALS DOMPERON

NDA/MAL/HDP/0668 CADILA PHARMACEUTICALS TELI 40

NDA/MAL/HDP/3779 LOSIUM 50

NDA/MAL/HDP/4015 TAMBAC 50

NDA/MAL/HDP/5300 CADILA PHARMACEUTICALS DOLAC

NDA/MAL/HDP/5619 RABELOC 20

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

ORITAXIM 1000MG INJECTION

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

Page 92: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1941 CADILA PHARMACEUTICALS RABELOC IV

NDA/MAL/HDP/2765 CADILA PHARMACEUTICALS HAEM F

NDA/MAL/HDP/3571 CADILA PHARMACEUTICALS CADIPHEN EXPECTORANT

NDA/MAL/HDP/6843 FYTOBACT

NDA/MAL/HDP/0587 CADIGREL

NDA/MAL/HDP/0130 TRIGAN -D

NDA/MAL/HDP/0586 CADILA PHARMACEUTICALS ONSETT

NDA/MAL/HDP/0676 CADILA PHARMACEUTICALS ONSETT 4

NDA/MAL/HDP/3902 NODON

NDA/MAL/HDP/6845 FYTOBACT 2G

NDA/MAL/HDP/8123 CADILA PHARMACEUTICALS MYCIDAC- C

NDA/MAL/HDP/6716 CATAFLAM 50

NDA/MAL/HDP/0576 GLAXO SMITH KLINE LTD ERIS LTD DUODART

NDA/MAL/HDP/1264

NDA/MAL/HDP/4867 MICONA ORAL GEL

NDA/MAL/HDP/1976 OROGEL

NDA/MAL/HDP/2415 SOLINA TABLETS

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

KARURI PHARMACEUTICALS LTD.

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

CENTAUR DRUG HOUSE PVT LIMITED

GITTOES PHARMACEUTICALS LIMITED

OCUCYCLINE EYE OINTMENT

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

Page 93: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2802 TASOL

NDA/MAL/HDP/2942 ARGISSEPT CREAM

NDA/MAL/HDP/2141 INFLAZONE

NDA/MAL/HDP/3754 SINAREST PD NASAL DROPS

NDA/MAL/HDP/2982 NEURO-FORTE TABLETS

NDA/MAL/HDP/3574 METOZ 2.5 TABLET

NDA/MAL/HDP/3581 METOZ 5

NDA/MAL/HDP/2940 BENZOX 5 GEL

NDA/MAL/HDP/2018 ORAXIN SYRUP

NDA/MAL/HDP/4182 SINAREST- FORTE

NDA/MAL/HDP/5122 KOFAREST SYRUP

NDA/MAL/HDP/4118 OCUREST-AH

NDA/MAL/HDP/3357 ESOREST 20

NDA/MAL/HDP/3364 ESOREST 40

NDA/MAL/HDP/8242 IDA FOUNDATION KIMSY MEDS LTD

NDA/MAL/HDP/3800 COLDAREST

CENTAUR DRUG HOUSE PVT LIMITED

GITTOES PHARMACEUTICALS LIMITED

CENTAUR DRUG HOUSE PRIVATE LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR DRUG HOUSE PRIVATE LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR DRUG HOUSE PRIVATE LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PRIVATE LIMITED

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PRIVATE LIMITED

GITTOES PHARMACEUTICALS LIMITED

CENTAUR DRUG HOUSE PRIVATE LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

TETRACYCLINE HYDROCHLORIDE

CENTAUR DRUG HOUSE PVT LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 94: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5228 DICLOGENTA

NDA/MAL/HDP/5415 SINAREST

NDA/MAL/HDP/1589 CENTACID SUSPENSION

NDA/MAL/HDP/1591 CENTIPAR ELIXIR

NDA/MAL/HDP/4023 SINAREST LINCTUS

NDA/MAL/HDP/4101 AMLOTRUST 5

NDA/MAL/HDP/5185 HB FORTE

NDA/MAL/HDP/2717 OCUMYCIN EYE OINTMENT

NDA/MAL/HDP/2920 TRANSLIPO -C CREAM

NDA/MAL/HDP/3977 NO-SPA

NDA/MAL/HDP/4082 SANOFI AVENTIS NO-SPA FORTE

NDA/MAL/HDP/2569 SANOFI AVENTIS NO-SPA

NDA/MAL/HDP/3191 CIPLA LTD ERECTO -100

NDA/MAL/HDP/3193 CIPLA LTD ERECTO- 50

NDA/MAL/HDP/3220 CIPLA LTD PYLO KIT

NDA/MAL/HDP/8466 CIPLA LIMITED LUMARTEM HS 80

NDA/MAL/HDP/6183 CIPLA LTD.. PRAZIQUANTEL TABLETS

NDA/MAL/HDP/4880 CIPLA LTD MISOPROST 200

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CENTAUR DRUG HOUSE PVT LIMITED

GITTOES PHARMACEUTICALS LIMITED

CENTAUR PHARMACEUTICALS LTD

GITTOES PHARMACEUTICALS LIMITED

CHINOIN PHARMACEUTICALS AND CHEMICAL WORKS, CO. LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

Page 95: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1399 CIPLA LTD. ASTHALIN

NDA/MAL/HDP/2175 CIPLA LTD PARAFIZZ

NDA/MAL/HDP/5374 CIPLA LIMITED. LAMIVIR ORAL SOLUTION

NDA/MAL/HDP/3062 CIPLA

NDA/MAL/HDP/2188 CIPLA LTD PREDNISOLONE

NDA/MAL/HDP/2262 CIPLA LTD

NDA/MAL/HDP/2603 CIPLA LTD VIRADAY

NDA/MAL/HDP/4899 CIPLA LIMITED CLOSERINE

NDA/MAL/HDP/2507 CIPLA LTD EXERMET 1000

NDA/MAL/HDP/5389 CIPLA LTD LUMARTEM

NDA/MAL/HDP/6061 CIPLA LTD.. NASEHALER

NDA/MAL/HDP/8250 CIPLA LTD LUMARTEM DT

NDA/MAL/HDP/1156 CIPLA LTD FUNGICIP

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

LAMIVUDINE,ZIDOVUDINE, NEVIRAPINE

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

TENOFOVIR DISOPROXIL FUMARATE

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

Page 96: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6173 CIPLA LTD.. MONTAIR 5

NDA/MAL/HDP/0608 CIPLA LTD

NDA/MAL/HDP/4376 CIPLA LTD.

NDA/MAL/HDP/5360 CIPLA LIMITED MOXICIP 400

NDA/MAL/HDP/3480 CIPLA LTD HYOSPAN

NDA/MAL/HDP/6652 CIPLA LTD.

NDA/MAL/HDP/6655 CIPLA LTD. ATORLIP-20

NDA/MAL/HDP/2497 CIPLA LTD NEVIMUNE

NDA/MAL/HDP/3286 CIPLA LIMITED LOMAC-20

NDA/MAL/HDP/1777 CIPLA LTD NUZAC 20

NDA/MAL/HDP/2983 CIPLA LTD. FORCAN-200

NDA/MAL/HDP/8093 CIPLA LTD DUOVIR-N

NDA/MAL/HDP/5457 CIPLA LIMITED FALCIMON 100/270 B/L

NDA/MAL/HDP/5458 CIPLA LTD FALCIMON 50/135 B/L

NDA/MAL/HDP/2402 IDA FOUNDATION KIMSY MEDS LTD PRAZIQUANTEL

NDA/MAL/HDP/3553 CIPLA LTD. FALCIMON 25/67.5 B/L

NDA/MAL/HDP/1384 CIPLA LTD

NDA/MAL/HDP/1381 CIPLA LTD

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

LOPINAVIR AND RITONAVIR TABLETS 200MG/50MG

QUALITY CHEMICALS LTD - HUMAN

EFAVIRENZ+LAMIVUDINE & TENOFOVIR TABLETS

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

LAMIVUDINE +TENOFOVIR DISOPROXIL FUMARATE

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANCIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

LAMIVUDINE AND ZIDOVUDINE TABLETS

QUALITY CHEMICALS LTD - HUMAN

LAMIVUDINE,/ ZIDOVUDINE TABLETS

Page 97: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4647 CIPLA LTD.. LEVOLIN

NDA/MAL/HDP/5202 CIPLA LIMITED HYDROCORT INJECTION

NDA/MAL/HDP/5371 CIPLA LIMITED. LAMIVUDINE

NDA/MAL/HDP/5478 CIPLA LTD BECLATE-50

NDA/MAL/HDP/5480 CIPLA LTD BECLATE NASAL SPRAY

NDA/MAL/HDP/2092 CIPLA LTD DUOVIR-N

NDA/MAL/HDP/2671 CIPLA LTD.. DUOLIN RESPULES

NDA/MAL/HDP/2910 CIPLA LTD TENVIR EM

NDA/MAL/HDP/3041 CIPLA LTD LEVOFLOXACIN

NDA/MAL/HDP/3049 CIPLA LTD.. EFAVIRENZ

NDA/MAL/HDP/3088 CIPLA LTD PILL 72

NDA/MAL/HDP/3228 CIPLA LTD ENTOSEC

NDA/MAL/HDP/3441 CIPLA LTD LEVOFLOXACIN

NDA/MAL/HDP/3548 CIPLA LTD BECLATE 200

NDA/MAL/HDP/3558 CIPLA LTD SEROFLO-250

NDA/MAL/HDP/3684 CIPLA LTD I-PILL

NDA/MAL/HDP/8021 CIPLA LIMITED LAMIVIR-150 TABLETS

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

Page 98: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8022 CIPLA LTD.

NDA/MAL/HDP/5252 CIPLA LIMITED. ENCLEX-40

NDA/MAL/HDP/1698 CIPLA LTD AZEE-500

NDA/MAL/HDP/2966 CIPLA LTD TENVIR

NDA/MAL/HDP/8032 CIPLA LTD.

NDA/MAL/HDP/8229 CIPLA LTD.

NDA/MAL/HDP/3141 CIPLA LTD. AMLOPRESS-5

NDA/MAL/HDP/3182 CIPLA LTD TADACIP 20

NDA/MAL/HDP/3215 CIPLA LTD SEROFLO-125MG

NDA/MAL/HDP/3920 CIPLA LTD PHOTERICIN B

NDA/MAL/HDP/3326 CIPLA LTD AMICIP

NDA/MAL/HDP/1255 CIPLA LTD NIFELAT RETARD

NDA/MAL/HDP/3055 CIPLA LTD. ABACAVIR SULFATE

NDA/MAL/HDP/6657 CIPLA LTD. METFORMIN

NDA/MAL/HDP/4351 CIPLA LTD ABACAVIR SULFATE

NDA/MAL/HDP/0189 CIPLA LTD NEVIMUNE TABLETS

NDA/MAL/HDP/4869 CIPLA LIMITED. MICOGEL CREAM

NDA/MAL/HDP/3084 CIPLA LIMITED NEVIRAPINE

NDA/MAL/HDP/3212 CIPLA LTD. CLOPIVAS 75MG

NDA/MAL/HDP/2679 CIPLA LTD. ALERID SYRUP

NDA/MAL/HDP/1360 CIPLA LTD ABAMUNE-L BABY

NDA/MAL/HDP/5236 CIPLA LTD.

QUALITY CHEMICALS LTD - HUMAN

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

ABACAVIR SULFATE/LAMIVUDINE

QUALITY CHEMICALS LTD - HUMAN

ABACAVIR SULFATE + LAMIVUDINE

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

ETHIONAMIDE TABLETS USP

Page 99: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3491 CIPLA LTD. BENDEX-400

NDA/MAL/HDP/1907 CIPLA LTD ABACAVIR

NDA/MAL/HDP/3968 CIPLA LTD NORLUT-N

NDA/MAL/HDP/3972 CIPLA LTD. FERTOMID-50

NDA/MAL/HDP/1525 CIPLA LTD BENDEX

NDA/MAL/HDP/2527 ACIVIR CREAM

NDA/MAL/HDP/0196 DUOVIR

NDA/MAL/HDP/0198 CIPLA LIMITED

NDA/MAL/HDP/1811 CIPLA LTD DUOVIR TABLETS

NDA/MAL/HDP/0480 TRIODAY

NDA/MAL/HDP/5372 CIPLA LTD DUOMUNE

NDA/MAL/HDP/0197 CIPLA LTD EFAVIR-600

NDA/MAL/HDP/1906

NDA/MAL/HDP/7162 TEXAVIR

NDA/MAL/HDP/7274 ZENTAIR 0.5MG

NDA/MAL/HDP/7663 ZENTAIR

NDA/MAL/HDP/7449

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMANQUALITY CHEMICALS LTD - HUMAN

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

QUALITY CHEMICALS LTD - HUMAN

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

NEVIRAPINE TABLETS 200 MG

QUALITY CHEMICALS LTD - HUMAN

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

EFAVIRENZ TABLETS 600MG

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

LAMIVUDINE/ TENOFOVIR DF 300/300MG

Page 100: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7617

NDA/MAL/HDP/6999

NDA/MAL/HDP/5067 RENE PHARMACY LTD LUFENAC

NDA/MAL/HDP/5380 RENE PHARMACY LTD CIROZEP

NDA/MAL/HDP/1171 RENE PHARMACY LTD BETNEW EYE / EAR DROP

NDA/MAL/HDP/1172 RENE PHARMACY LTD

NDA/MAL/HDP/1167 RENE PHARMACY LTD

NDA/MAL/HDP/2923 RENE PHARMACY LTD COLD PLUS SYRUP

NDA/MAL/HDP/6548 CIROPAIN GEL

NDA/MAL/HDP/8201 RENE PHARMACY LTD CENTROZINE

NDA/MAL/HDP/8210 RENE PHARMACY LTD

NDA/MAL/HDP/1069 RENE PHARMACY LTD K-ONE INJECTION

NDA/MAL/HDP/3873 RENE PHARMACY LTD

NDA/MAL/HDP/3938 RENE PHARMACY LTD ADRENALINE INJECTION

NDA/MAL/HDP/4737 RENE PHARMACY LTD CICOL DROPS

NDA/MAL/HDP/4737 CICOL DROPS

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600 MG/300 MG /300 MG

CIRON DRUGS & PHARMACEUTICAL PVT LTD

ROYAL PHARMA 2011 LIMITED

NYSTATIN ORAL SUSPENSION

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

LIDOCAINE HYDROCHLORIDE

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

METOCLOPRAMIDE INJECTION

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICAL PVT LTD

ROYAL PHARMA 2011 LIMITED

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICALS PVT LTD

HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CHLORPROMAZINE INJECTION B.P

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

Page 101: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4783 RENE PHARMACY LTD CYPOTIN

NDA/MAL/HDP/4783 CYPOTIN

NDA/MAL/HDP/3635 RENE PHARMACY LTD CIROGAN

NDA/MAL/HDP/8209 RENE PHARMACY LTD

NDA/MAL/HDP/3485 RENE PHARMACY LTD ERGOMETRINE

NDA/MAL/HDP/3594 RENE PHARMACY LTD

NDA/MAL/HDP/1432 RENE PHARMACY LTD

NDA/MAL/HDP/4587 RENE PHARMACY LTD CIRATRO

NDA/MAL/HDP/4979 RENE PHARMACY LTD FUROSEMIDE

NDA/MAL/HDP/5013 RENE PHARMACY LTD

NDA/MAL/HDP/3584 RENE PHARMACY LTD

NDA/MAL/HDP/8208 RENE PHARMACY LTD

NDA/MAL/HDP/6246 RENE PHARMACY LTD LUTHER

NDA/MAL/HDP/6660 CLARIS INJECTABLES LTD KETAJEX

NDA/MAL/HDP/1520 CLARIS INJECTABLES LTD FLUCANOL

NDA/MAL/HDP/5438 CLARIS INJECTABLES LTD TAMIN

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICAL PVT LTD

THIOPENTAL SODIUM INJECTION

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICALS PVT LTD

STERILE QUININE DIHYDROCHLORIDE

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CHLORAMPHENICOL EAR DROPS

CIRON DRUGS AND PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CIRON DRUGS & PHARMACEUTICALS PVT LTD

GENTAMYCIN EYE/EAR DROPS

CIRON DRUGS & PHARMACEUTICALS PVT LTD

CHLORAMPHENICOL EYE DROPS

CIRON DRUGS & PHARMACEUTICAL PVT LTD

CHLORAMPHENICOL SODIUM SUCCINATE

CIRON DRUGS & PHARMACEUTICALS PVT LTD

REDDYS PHARMA LIMITEDREDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

Page 102: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2045 CLARIS INJECTABLES LTD BUPICAN

NDA/MAL/HDP/3396 CLARIS INJECTABLES LTD BUPICAN HEAVY

NDA/MAL/HDP/3797 CLARIS INJECTABLES LTD PROVIVE 1%

NDA/MAL/HDP/6124 CLARIS LIFE SCIENCES LTD SPIVA

NDA/MAL/HDP/6063 CLARIS LIFESCIENCE LTD ANSED

NDA/MAL/HDP/6140 CLARIS OTSUKA LIMITED KIDROLYTE

NDA/MAL/HDP/0945 ZOFEX

NDA/MAL/HDP/2749 CLARIS LIFESCIENCE LTD HESTAR-200 PENTASTARCH

NDA/MAL/HDP/3701 ASTRA ZENECA MACNAUGHTON LIMITED DIPRIVAN

NDA/MAL/HDP/3713 ASTRA ZENECA MACNAUGHTON LIMITED DIPRIVAN

NDA/MAL/HDP/6914 I CARE PHARMA LIMITED PANZOLE TABLETS

NDA/MAL/HDP/6924 I CARE PHARMA LIMITED AIVEEN (U) LIMITED NAC MR

NDA/MAL/HDP/6422 AIVEEN (U) LIMITED EMADON

NDA/MAL/HDP/1911 COSMOS LTD

NDA/MAL/HDP/8180 COSMOS LTD COSMOL TABLETS 500MG

NDA/MAL/HDP/1011 COSMOS LTD DABORAL SYRUP

REDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

CLARIS LIFE SCIENCES LIMITED

REDDYS PHARMA LIMITED

REDDYS PHARMA LIMITED

AIVEEN (U) LTD - WILSON ROAD

INTERNATIONAL ORGANIZATION FOR MIGRATION

ASTRA PHARMA (U) LIMITED

CODIENE PHOSPHATE TABLETS BP 30

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

Page 103: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0784 COSMOS LTD HEMOSAN

NDA/MAL/HDP/0746 COSMOS LTD DTS-Z KIT

NDA/MAL/HDP/0879 COSMOS LTD.

NDA/MAL/HDP/1007 COSMOS LTD

NDA/MAL/HDP/4710 COSMOS LTD

NDA/MAL/HDP/1254 COSMOS LTD COSATRIM TABLETS

NDA/MAL/HDP/0948 COSMOS LTD

NDA/MAL/HDP/0141 COSMOS LTD NYCOSTAT SUSPENSION

NDA/MAL/HDP/0296 COSMOS LTD PRAZITEL TABLETS

NDA/MAL/HDP/1565 COSMOS LTD SALBUT SYRUP 2MG/5ML

NDA/MAL/HDP/3752 COSMOS LTD PAINOTAB 200

NDA/MAL/HDP/3837 COSMOS LTD NITROFURANTOIN

NDA/MAL/HDP/3904 COSMOS LTD NYCOSTAT PESSARIES

NDA/MAL/HDP/4144 COSMOS LTD NYCOSTAT OINTMENT

NDA/MAL/HDP/4400 COSMOS LTD

NDA/MAL/HDP/4544 COSMOS LTD SALBUT TABLET 4MG

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

TRIBEES FORTE FILM COATED TABLETS

ASTRA PHARMA (U) LIMITED

ZINCOS DISPERSIBLE TABLETS 20MG

ASTRA PHARMA (U) LIMITED

MEDOPRESS TABLETS 250MG

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

LORHISTINA SYRUP 5MG/5ML

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ORAL REHYDRATION SALT (DTS)

ASTRA PHARMA (U) LIMITED

Page 104: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4974 COSMOS LTD

NDA/MAL/HDP/5042 COSMOS LTD COSATRIM DS TABLETS

NDA/MAL/HDP/5099 COSMOS LTD GLUCOMET

NDA/MAL/HDP/5200 COSMOS LTD

NDA/MAL/HDP/1856 COSMOS LTD

NDA/MAL/HDP/2374 COSMOS LTD PYRAZINAMIDE TABLETS

NDA/MAL/HDP/2385 COSMOS LIMITED COZEPAM 5MG

NDA/MAL/HDP/2555 COSMOS LTD

NDA/MAL/HDP/3516 COSMOS LTD

NDA/MAL/HDP/6698 COSMOS LTD ALBUZOL 400MG TABLETS

NDA/MAL/HDP/8297 COSMOS LTD ISONIAZIDE TABLETS

NDA/MAL/HDP/2101 COSMOS LTD CARDISPRIN

NDA/MAL/HDP/2319 COSMOS LTD COSMOL

NDA/MAL/HDP/0424 COSMOS LTD

NDA/MAL/HDP/0278 COSMOS LTD

NDA/MAL/HDP/4148 COSMOS LIMITED AMITRIPTYLINE TABLETS

NDA/MAL/HDP/4982 COSMOS LTD COSMAG TABLETS

ASTRA PHARMA (U) LIMITED

FRUSEMIDE TABLETS BP 40MG

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

HYDRALAZINE TABLETS B.P 25MG.

ASTRA PHARMA (U) LIMITED

PROPRANOLOL TABLETS B.P. 40MG

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

PHENOBARBITONE TABLETS BP 30MG

ASTRA PHARMA (U) LIMITED

BENZHEXOL TABLETS BP 5MG

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

CHLORPROMAZINE TABLETS B.P 25MG

ASTRA PHARMA (U) LIMITED

CHLORPROMAZINE TABLETS B.P 100MG

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

Page 105: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5164 COSMOS LTD BROMSAL EXPECTORANT

NDA/MAL/HDP/5259 COSMOS LTD CARDINOL TABLET

NDA/MAL/HDP/5334 COSMOS LTD ETHAM-400

NDA/MAL/HDP/1730 COSMOS LTD ZITHROX

NDA/MAL/HDP/2009 COSMOS LTD ZITHROX

NDA/MAL/HDP/2043 COSMOS LTD DIASTOP TABLETS

NDA/MAL/HDP/2046 COSMOS LTD LORHISTINA

NDA/MAL/HDP/2085 COSMOS LTD

NDA/MAL/HDP/2460 COSMOS LTD BENZHEXOL TABLETS 2MG

NDA/MAL/HDP/3073 COSMOS LTD CARDINOL TABLET

NDA/MAL/HDP/3178 COSMOS LTD BENDURIC TABLETS

NDA/MAL/HDP/3374 COSMOS LIMITED ZITHROX 250MG

NDA/MAL/HDP/3610 COSMOS LTD

NDA/MAL/HDP/6728 COSMOS LTD CIPROCOS-500 TABLETS

NDA/MAL/HDP/6729 COSMOS LTD COSCOF 'C' LINCTUS

NDA/MAL/HDP/6732 COSMOS LTD

NDA/MAL/HDP/6762 COSMOS LTD FLUCOLD CAPSULES

NDA/MAL/HDP/8009 COSMOS LTD. GRISO-500

NDA/MAL/HDP/8010 COSMOS LTD. METROZOLE TABLETS

NDA/MAL/HDP/1924 ASTRA PHARMA (U) LIMITED AMPICILLIN SODIUM

NDA/MAL/HDP/0266 ASTRA PHARMA (UK) LTD

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

CHLORHEXIDINE GLUCONATE SOLUTION

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

PROMETHAZINE TABLETS BP 25MG

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

COSCOF EXPECTORANT ORIGINAL

ASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITEDASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

BENZATHINE PENICILLIN INJECTION

Page 106: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3817 ROYAL PHARMA

NDA/MAL/HDP/4241

NDA/MAL/HDP/4969 BENZATHINE PENICILLIN

NDA/MAL/HDP/5644

NDA/MAL/HDP/2223 ROYAL PHARMA

NDA/MAL/HDP/2796 ASTRA PHARMA (UK) LTD

NDA/MAL/HDP/3270 ASTRA PHARMA (UK) LTD

NDA/MAL/HDP/3328

NDA/MAL/HDP/3522

NDA/MAL/HDP/3618 ASTRA PHARMA (U) LIMITED CLOXACILLIN SODIUM

NDA/MAL/HDP/3717 CEFTRIAXONE SODIUM

NDA/MAL/HDP/2725 ASTRA PHARMA (U) LTD

NDA/MAL/HDP/4781 CYANO PHARMA(P) RENE PHARMACY LTD CYANO IRON TABLETS

NDA/MAL/HDP/5072 CYANO PHARMA(P) RENE PHARMACY LTD DEXAMETHASONE TABLETS

NDA/MAL/HDP/3526 CYANO PHARMA(P) RENE PHARMACY LTD PROMETHAZINE TABLETS

NDA/MAL/HDP/1867 RENE PHARMACY(R) LTD.. RENE PHARMACY LTD LEVATEX TABLETS

NDA/MAL/HDP/2061 RENE PHARMACY(R) LTD.. RENE PHARMACY LTD ADSOCARB TABLETS

NDA/MAL/HDP/2806 RENE INDUSTRIES LIMITED RENE PHARMACY LTD

NDA/MAL/HDP/8124 RENE PHARMACY(R) LTD.. RENE PHARMACY LTD CODEINE PHOSPHATE

ROYAL PHARMA 2011 LIMITED

BENZYLPENICILLIN INJECTION

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AMPICILLIN SODIUM FOR INJECTION BP

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

FORTIFIED PROCAINE PENICILLIN

ROYAL PHARMA 2011 LIMITED

BENZATHINE PENICILLIN INJECTION

ASTRA PHARMA (U) LIMITED

BENZYLPENICILLIN INJECTION

ASTRA PHARMA (U) LIMITED

FORTIFIED PROCAINE PENICILLIN

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

BENZYLPENICILLIN INJECTION

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

CLOXACILLIN SODIUM FOR INJECTION

ASTRA PHARMA (U) LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

ASTRA PHARMA (U) LIMITED

STREPTOMYCIN SULPHATE FOR INJECTION

PHENOBARBITONE TABLETS

Page 107: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1466 KIMSY MEDS LTD METADOR

NDA/MAL/HDP/1055 KIMSY MEDS LTD ROZITTA 40

NDA/MAL/HDP/4078 KIMSY MEDS LTD EPIGAB

NDA/MAL/HDP/4945 KIMSY MEDS LTD FORMIT

NDA/MAL/HDP/5046 KIMSY MEDS LTD GIZLAN PLUS 150/12.5

NDA/MAL/HDP/5049 KIMSY MEDS LTD GIZLAN PLUS 300/12.5

NDA/MAL/HDP/5093 KIMSY MEDS LTD LIPODAR 10

NDA/MAL/HDP/5350 KIMSY MEDS LTD CEPHADAR FORTE

NDA/MAL/HDP/5351 KIMSY MEDS LTD CEPHADAR

NDA/MAL/HDP/6188 KIMSY MEDS LTD GIZLAN 150

NDA/MAL/HDP/3500 KIMSY MEDS LTD GIZLAN 300

NDA/MAL/HDP/2437 KIMSY MEDS LTD RISDONE

NDA/MAL/HDP/2295 KIMSY MEDS LTD ROZITTA 10

NDA/MAL/HDP/2299 KIMSY MEDS LTD ROZITTA 20

NDA/MAL/HDP/3724 KIMSY MEDS LTD EPIGAB

NDA/MAL/HDP/8125 KIMSY MEDS LTD MATADOR

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD

Page 108: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4657 KIMSY MEDS LTD VOLAR 300MG

NDA/MAL/HDP/4660 KIMSY MEDS LTD RISDONE 2MG

NDA/MAL/HDP/4663 KIMSY MEDS LTD LORATAN

NDA/MAL/HDP/4669 KIMSY MEDS LTD

NDA/MAL/HDP/4675 KIMSY MEDS LTD DICLOGESIC RETARD 100

NDA/MAL/HDP/4704 KIMSY MEDS LTD DICLOGESIC 12.5

NDA/MAL/HDP/4705 KIMSY MEDS LTD DICLOGESIC-50

NDA/MAL/HDP/4759 KIMSY MEDS LTD CIPRODAR

NDA/MAL/HDP/4795 KIMSY MEDS LTD DAROXIME

NDA/MAL/HDP/4895 KIMSY MEDS LTD CLOMIFERT

NDA/MAL/HDP/4948 KIMSY MEDS LTD FORMIT 1000

NDA/MAL/HDP/4950 KIMSY MEDS LTD FORMIT 500

NDA/MAL/HDP/1618 KIMSY MEDS LTD AMOXYDAR

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DICLOGESIC 100MG SUPPOSITORIES

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

Page 109: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3897 KIMSY MEDS LTD CLAVODAR

NDA/MAL/HDP/4666 KIMSY MEDS LTD ANTIPLEX

NDA/MAL/HDP/4804 KIMSY MEDS LTD CLAVODAR

NDA/MAL/HDP/5321 KIMSY MEDS LTD IBUGESIC COLD & SINUS

NDA/MAL/HDP/3125 KIMSY MEDS LTD AMLODAR 5

NDA/MAL/HDP/2734 KIMSY MEDS LTD AMLODAR-10

NDA/MAL/HDP/2686 KIMSY MEDS LTD AMOXYDAR FORTE

NDA/MAL/HDP/2129 KIMSY MEDS LTD CLAVODAR

NDA/MAL/HDP/2960 KIMSY MEDS LTD CLAVODAR

NDA/MAL/HDP/1792 KIMSY MEDS LTD LIPODAR

NDA/MAL/HDP/3139 KIMSY MEDS LTD OMEDAR

NDA/MAL/HDP/0119 DAWA LIMITED SUPER MEDIC LTD DACOLD

NDA/MAL/HDP/1105 DAWA LIMITED SUPER MEDIC LTD DERMAZINE PLUS

NDA/MAL/HDP/2297 DAWA LIMITED SUPER MEDIC LTD SABULIN SYRUP

NDA/MAL/HDP/2387 DAWA LIMITED SUPER MEDIC LTD VERMOUT

NDA/MAL/HDP/1168 DAWA LIMITED SUPER MEDIC LTD DAWA-CORT CREAM

NDA/MAL/HDP/0124 DAWA LIMITED SUPER MEDIC LTD AMPECIN

NDA/MAL/HDP/0126 DAWA LIMITED SUPER MEDIC LTD WHITFIELD'S

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD

Page 110: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1015 DAWA LIMITED SUPER MEDIC LTD ORACEF

NDA/MAL/HDP/0550 DAWA LIMITED SUPER MEDIC LTD DA-ZEPAM

NDA/MAL/HDP/1185 DAWA LIMITED SUPER MEDIC LTD DACOF DRY

NDA/MAL/HDP/1186 DAWA LIMITED SUPER MEDIC LTD DACOF EXPECTORANT

NDA/MAL/HDP/1082 DAWA LIMITED SUPER MEDIC LTD DACOF PAEDIATRIC

NDA/MAL/HDP/0467 SUPER MEDIC LTD CURAMOL PLUS

NDA/MAL/HDP/0318 DAWA LIMITED SUPER MEDIC LTD SABULIN

NDA/MAL/HDP/1184 DAWA LIMITED SUPER MEDIC LTD DACOF MUCOLYTIC

NDA/MAL/HDP/0125 DAWA LIMITED SUPER MEDIC LTD SULPHUR OINTMENT

NDA/MAL/HDP/3966 DAWA LIMITED SUPER MEDIC LTD ASCORBIC ACID TABLETS

NDA/MAL/HDP/4800 DAWA LIMITED SUPER MEDIC LTD DAWAVITE SYRUP

NDA/MAL/HDP/4872 DAWA LIMITED SUPER MEDIC LTD MICLOCIN CREAM

NDA/MAL/HDP/3687 DAWA LIMITED SUPER MEDIC LTD DAWA-PROM

NDA/MAL/HDP/3466 DAWA LIMITED SUPER MEDIC LTD DAWASEC

NDA/MAL/HDP/3657 DAWA LIMITED SUPER MEDIC LTD DAWASTIN

NDA/MAL/HDP/6686 DAWA LIMITED SUPER MEDIC LTD DAWASOLONE

NDA/MAL/HDP/6761 ADCOCK INGRAM LIMITED DAWANOL TABLETS

NDA/MAL/HDP/7329 DAWA LIMITED SUPER MEDIC LTD ACEPAR- MR

NDA/MAL/HDP/1367 DAWA LIMITED SUPER MEDIC LTD ACEPAR

NDA/MAL/HDP/1084 DAWA LIMITED SUPER MEDIC LTD DAWA-CPM

NDA/MAL/HDP/0542 DAWA LIMITED SUPER MEDIC LTD PHENBITAL

DAWA PHARMACEUTICALS LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

Page 111: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4104 DAWA LIMITED SUPER MEDIC LTD DAWA-PROM

NDA/MAL/HDP/4335 DAWA LIMITED SUPER MEDIC LTD CURAMOL SUSPENSION

NDA/MAL/HDP/4629 DAWA LIMITED SUPER MEDIC LTD ORACEF

NDA/MAL/HDP/3101 DAWA LIMITED SUPER MEDIC LTD DACOLD SYRUP

NDA/MAL/HDP/8235 DAWA LIMITED SUPER MEDIC LTD ACEPAR

NDA/MAL/HDP/8434 DAWA LIMITED SUPER MEDIC LTD DACINAZOLE

NDA/MAL/HDP/0693 DAWA LIMITED SUPER MEDIC LTD MOXACIL -250

NDA/MAL/HDP/0221 DAWA LIMITED SUPER MEDIC LTD AMPICLO-DAWA

NDA/MAL/HDP/0283 DAWA LIMITED SUPER MEDIC LTD AMPICLO-DAWA

NDA/MAL/HDP/1109 DAWA LIMITED SUPER MEDIC LTD DAWA-CPM

NDA/MAL/HDP/1111 DAWA LIMITED SUPER MEDIC LTD FAST-ACT GEL

NDA/MAL/HDP/0139 SUPER MEDIC LTD MOXAFORTE

NDA/MAL/HDP/2269 DAWA LIMITED SUPER MEDIC LTD DAWAMOX

NDA/MAL/HDP/1508 DAWA LIMITED SUPER MEDIC LTD WOMNIL

NDA/MAL/HDP/2893 DAWA LIMITED SUPER MEDIC LTD STOPACID SUSPENSION

NDA/MAL/HDP/3808 NORVATIS PHARMA AG

NDA/MAL/HDP/2783 NOVARTIS PHARMA AG

NDA/MAL/HDP/3163 NORVATIS PHARMA AG

NDA/MAL/HDP/2239 NOVARTIS PHARMA AG

ANGLIAN NUTRITION PRODUCTS COMPANY

SURGIPHARM (U) LIMITED

VOLTAREN SUPPOSITORIES 12.5MG

SURGIPHARM (U) LIMITED

VOLTAREN SUPPOSITORIES 25MG

SURGIPHARM (U) LIMITED

VOLTAREN SUPPOSITORIES 50MG

SURGIPHARM (U) LIMITED

TEGRETOL ORAL SUSPENSION

Page 112: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4315 BENLE CONSULT LIMITED DESLORA-DENK 5

NDA/MAL/HDP/4322 BENLE CONSULT LIMITED VALSAR-DENK 160

NDA/MAL/HDP/4332 BENLE CONSULT LIMITED VALSAR-DENK 320

NDA/MAL/HDP/4337 BENLE CONSULT LIMITED VALSAR-DENK 80

NDA/MAL/HDP/2650 DENK PHARMA BENLE CONSULT LIMITED VIT-B-DENK

NDA/MAL/HDP/3583 DENK PHARMA GMBH & CO BENLE CONSULT LIMITED SIMVA-DENK 40

NDA/MAL/HDP/4147 ERIS LTD BENLE CONSULT LIMITED NIFEDI-DENK 20 RETARD

NDA/MAL/HDP/2296 ERIS LTD BENLE CONSULT LIMITED RANI-DENK 150

NDA/MAL/HDP/1492 ERIS LTD BENLE CONSULT LIMITED DICLO-DENK 75 INJECTION

NDA/MAL/HDP/0754 BENLE CONSULT LIMITED TORAS DENK 10

NDA/MAL/HDP/1219 BENLE CONSULT LIMITED TORAS-DENK 5

NDA/MAL/HDP/3728 ERIS LTD BENLE CONSULT LIMITED DICLO-DENK 50

NDA/MAL/HDP/4317 BENLE CONSULT LIMITED COLOSAR-DENK 50/12.5

NDA/MAL/HDP/4634 BENLE CONSULT LIMITED LOSAR-DENK 100

NDA/MAL/HDP/4757 ERIS LTD BENLE CONSULT LIMITED METFORMIN-DENK 500

NDA/MAL/HDP/4758 BENLE CONSULT LIMITED METFORMIN DENK 1000

DENK PHARMA GMB H &CO. KGDENK PARMA GMBH & CO. KGDENK PARMA GMBH & CO. KGDENK PARMA GMBH & CO. KG

DENK PARMA GMBH & CO. KG

DENK PHARMA GMB H &CO. KG

DENK PHARMA GMB H &CO. KG

DENK PHARMA GMB H &CO. KG

DENK PHARMA GMB H &CO. KG

Page 113: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2525 ERIS LTD BENLE CONSULT LIMITED DICLO-DENK 100 RETARD

NDA/MAL/HDP/2647 DENK PHARMA BENLE CONSULT LIMITED IBUPROFEN DENK 400MG

NDA/MAL/HDP/2948 BENLE CONSULT LIMITED METFORMIN DENK 850

NDA/MAL/HDP/3631 BENLE CONSULT LIMITED ENA-DENK 10

NDA/MAL/HDP/8095 BENLE CONSULT LIMITED COLOSAR-DENK 100/12.5

NDA/MAL/HDP/4334 DENK PHARM GMBH&CO.KG BENLE CONSULT LIMITED LOSAR-DENK 50

NDA/MAL/HDP/5392 BENLE CONSULT LIMITED AMLO-DENK 10

NDA/MAL/HDP/5393 BENLE CONSULT LIMITED AMLO-DENK 5

NDA/MAL/HDP/2746 ERIS LTD BENLE CONSULT LIMITED ACYCLOVIR DENK 200

NDA/MAL/HDP/2429 ERIS LTD BENLE CONSULT LIMITED CLOTRI-DENK 100 VAGINAL

NDA/MAL/HDP/3197 ERIS LTD BENLE CONSULT LIMITED TRIAM-DENK 40 INJECTION

NDA/MAL/HDP/3619 ERIS LTD BENLE CONSULT LIMITED CAPTOPRIL DENK -25

NDA/MAL/HDP/6495 DAFRA PHARMA GMBH

DENK PHARMA GMBH & CO KG

DENK PHARMA GMBH & CO KG

DENK PHARMA GMB H &CO. KG

DENK PHARMA GMB H &CO. KG

DENK PHARMA GMB H &CO. KG

LABOREX UGANDA LIMITED

MACROLYN® 500 MG FILM COATED TABLETS

Page 114: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8131 DEVA HOLDING A.S DEGRA

NDA/MAL/HDP/8226 DEVA HOLDING A.S SALRES

NDA/MAL/HDP/8332 DEVA HOLDING A.S AZITRO 500 MG

NDA/MAL/HDP/6158 DEVA HOLDING A.S DESEFIN

NDA/MAL/HDP/6070 DEVA HOLDING A.S VAZKOR

NDA/MAL/HDP/6071 DEVA HOLDING A.S VAZKOR

NDA/MAL/HDP/1238 PHARMACARE LIMITED SEPTRIN INJECTION

NDA/MAL/HDP/8601 AMLOVAS 5MG

NDA/MAL/HDP/7319 SIPROSAN 500

NDA/MAL/HDP/7328 CARDIOSAN 10MG

NDA/MAL/HDP/2894 MUCOGEL SUSPENSION

NDA/MAL/HDP/2905 BRONCHOPHANE SYRUP

NDA/MAL/HDP/5019 COLOSPASMIN FORTE

NDA/MAL/HDP/7286

NDA/MAL/HDP/8224 OPTIGENT

NDA/MAL/HDP/7287 EPISTIGMIN 0.05%

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

BETA HEALTHCARE UGANDA LIMITED

DROGSAN İLAÇLARI SAN. VE TIC. A.Ş.

BUFFALO HEALTH CARE LTD

DROGSAN İLAÇLARI SAN. VE TIC. A.Ş.

BUFFALO HEALTH CARE LTD

DROGSAN İLAÇLARI SAN. VE TIC. A.Ş.

BUFFALO HEALTHCARE LTD

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

TOBRIN OPHTHALMIC OINTMENT

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 115: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2036 ELI-LILLY (SUISSE) SA HUMULIN REGULAR

NDA/MAL/HDP/3772 ELI-LILLY (SUISSE) SA HUMULIN N NPH

NDA/MAL/HDP/2150 ELI-LILLY (SUISSE) SA HUMULIN MIXTURE

NDA/MAL/HDP/4946 ESAPHARMA S.R.L.. MOVATE

NDA/MAL/HDP/5106 ESAPHARMA S.R.L.. LEMOVATE CREAM

NDA/MAL/HDP/6619 ESAPHARMA S.R.L.. ORANVATE

NDA/MAL/HDP/5445 ESKAYEF BANGLADESH LTD AZITHRAX 500

NDA/MAL/HDP/7130 LIFEPHARM FZE HEMOVIT CAPSULES

NDA/MAL/HDP/1106 EVA PHARMA DIACEREIN

NDA/MAL/HDP/0990 EVA PHARMA FUSIDERM CREAM

NDA/MAL/HDP/0986 EVA PHARMA CONVENTIN

NDA/MAL/HDP/1022 EVA PHARMA CONVENTIN

NDA/MAL/HDP/0997 EVA PHARMA GENUPHIL

NDA/MAL/HDP/1032 EVA PHARMA ARTHFREE 20

NDA/MAL/HDP/1003 EVA PHARMA ZEFICAM

NDA/MAL/HDP/1031 EVA PHARMA MOXIFLOX

NDA/MAL/HDP/0999 EVA PHARMA THIOEVA

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITEDBYAMAKA PHARMACEUTICALS CO. LTD

BYAMAKA PHARMACEUTICALS CO. LTD

BYAMAKA PHARMACEUTICALS CO. LTD

MEDVIN PHARMA LIMITED

AIVEEN (U) LTD - WILSON ROAD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 116: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1001 EVA PHARMA THIOTACID ACID

NDA/MAL/HDP/6073 EVA PHARMA MILGA

NDA/MAL/HDP/1767 EVA PHARMA PROSTEROL

NDA/MAL/HDP/6449 DESLORAT SYRUP

NDA/MAL/HDP/7246 DESLORAT

NDA/MAL/HDP/6068 ZIMEXIR 250

NDA/MAL/HDP/6069 ZIMEXIR 200MG

NDA/MAL/HDP/7153 TYLOPHEN®

NDA/MAL/HDP/8223 LORAXIME

NDA/MAL/HDP/1620 LORAXONE

NDA/MAL/HDP/5276 DORMICUM INJECTION

NDA/MAL/HDP/5278 ROCHE PRODUCTS LTD DORMICUM

NDA/MAL/HDP/1366 HERCEPTIN 440MG

NDA/MAL/HDP/4292 F. HOFFMANN LA-ROCHE HERCEPTIN 150MG

NDA/MAL/HDP/5101 LEXOTANIL

NDA/MAL/HDP/4562 PEGASYS

NDA/MAL/HDP/4275 F. HOFFMANN LA-ROCHE AVASTIN 100MG/4ML

NDA/MAL/HDP/4284 F. HOFFMANN LA-ROCHE AVASTIN 400MG/4ML

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES

GAMA PHARMACEUTICALS (U) LIMITED

EVA PHARMA FOR PHARMACEUTICALS & MEDICAL APPLIANCES

GAMA PHARMACEUTICALS (U) LIMITED

EXIR PHARMACEUTICAL COMPANY

UNEED GLOBAL GROUP LIMITED

EXIR PHARMACEUTICAL COMPANY

UNEED GLOBAL GROUP LIMITED

EXIR PHARMACEUTICAL COMPANY.

UNEED GLOBAL GROUP LIMITED

IRAN MEDICAL GROUP COMPANY

UNEED GLOBAL GROUP LIMITED

IRAN MEDICAL GROUP COMPANY

UNEED GLOBAL GROUP LIMITED

F.HOFFMANN-LA ROCHE LTD

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITED

F. HOFFMANN- LA ROCHE LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

F. HOFFMANN- LA ROCHE LTD

LABOREX UGANDA LIMITED

F. HOFFMANN- LA ROCHE LTD

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

Page 117: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1033 FAES FARMA S.A DYNAMOGEN

NDA/MAL/HDP/3771 FAES FARMA S.A BRONQUIDIAZINA C.R

NDA/MAL/HDP/2652 FLAGENTYL TABLETS

NDA/MAL/HDP/0712 ERIS LTD ZENTEL

NDA/MAL/HDP/3405 GLAXO SMITH KLINE LTD ERIS LTD

NDA/MAL/HDP/4819 FDC LTD AIVEEN (U) LIMITED ORAL REHYDRATION SALT

NDA/MAL/HDP/4575 FDC LTD AIVEEN (U) LIMITED PYRICORT EYE/EAR DROPS

NDA/MAL/HDP/6114 FDC LTD AIVEEN (U) LIMITED ZOXAN

NDA/MAL/HDP/1865 FDC LTD AIVEEN (U) LIMITED MYCODERM-C POWDER

NDA/MAL/HDP/2912 FDC LTD AIVEEN (U) LIMITED MYCODERM

NDA/MAL/HDP/8212 FDC LTD AIVEEN (U) LIMITED BACTIGEN EYE/EAR DROPS

NDA/MAL/HDP/8213 FDC LTD AIVEEN (U) LIMITED ZOCON 200

NDA/MAL/HDP/0768 FDC LTD AIVEEN (U) LIMITED PYRIMON EYE DROP

NDA/MAL/HDP/0722 FDC LTD AIVEEN (U) LIMITED IOTIM 0.5%

NDA/MAL/HDP/2754 FDC LTD AIVEEN (U) LIMITED ZATHRIN 500

NDA/MAL/HDP/3494 LABORATORIOS NOVAG SA GAMALATE B6 SOLUTION

NDA/MAL/HDP/0685 FERRER INTERNACIONAL S.A SOMAZINA

NDA/MAL/HDP/0687 FERRER INTERNACIONAL S.A SOMAZINA

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

AVENTIS PHARMA (PTY) LTD SOUTH AFRICA

LABOREX UGANDA LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

PANADOL BABY AND INFANT 120MG/5ML

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITED

Page 118: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0752 FERRER INTERNACIONAL S.A NUCLEO C.M.P FORTE

NDA/MAL/HDP/1214 FERRER INTERNACIONAL S.A NUCLEO C.M.P FORTE

NDA/MAL/HDP/1494 FERRER INTERNACIONAL S.A PEITEL 0.25%

NDA/MAL/HDP/1989 FERRER INTERNACIONAL S.A DERMOFIX

NDA/MAL/HDP/7724 FERRING GMBH MACNAUGHTON LIMITED MENOPUR

NDA/MAL/HDP/7611 FERRING GMBH MACNAUGHTON LIMITED PABAL

NDA/MAL/HDP/0401 L MONTUS

NDA/MAL/HDP/0515 FILSTAT 20

NDA/MAL/HDP/0512 FILSTAT 10

NDA/MAL/HDP/0520 FILSTAT 40

NDA/MAL/HDP/0507 FILDILOL 12.5

NDA/MAL/HDP/0509 FILDILOL 25

NDA/MAL/HDP/3678 REDINPLUS

NDA/MAL/HDP/0432 K MAC ORAL SOLUTION

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

FOURRTS (INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES (PVT) LTD

DELMAW ENTERPRISES LIMITED

FOURRTS LABORATORIES LTD

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

Page 119: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1456 SUCRAFIL O GEL

NDA/MAL/HDP/1337 FOURTS B

NDA/MAL/HDP/5119 KONTRAC 200

NDA/MAL/HDP/2143 GRISEOFIL

NDA/MAL/HDP/2145 METFIL 500

NDA/MAL/HDP/2147 DICLOFEN -50

NDA/MAL/HDP/5033 MEBFIL TABLETS

NDA/MAL/HDP/5086 GLIFIL M FORT

NDA/MAL/HDP/5324 IBUFIL 400

NDA/MAL/HDP/3592 MEGATRIM DS

NDA/MAL/HDP/3655 QUADRAJEL GEL

NDA/MAL/HDP/1987 FOMYCETIN

NDA/MAL/HDP/2492 PROFIL 25

NDA/MAL/HDP/2695 IDUMSTRA

NDA/MAL/HDP/2837 GRAMOFIL TABLETS

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURTS(INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

LABOREX UGANDA LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURRTS(INDIA) LABORATORIES PVT.LIMITED

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES PUT LTD

DELMAW ENTERPRISES LIMITED

FOURRTS (INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURTS(INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURTS(INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURTS(INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

FOURTS(INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

Page 120: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3683 COLD TABS FORTINSA

NDA/MAL/HDP/5307 DUOTROL

NDA/MAL/HDP/2151 USV LIMITED GLYCOMET 850

NDA/MAL/HDP/2154 GLYNASE

NDA/MAL/HDP/2970 GLYCOMET 500

NDA/MAL/HDP/0776 FREMOL TABLETS

NDA/MAL/HDP/4975 FRUSINA TABLETS

NDA/MAL/HDP/2643 NEOPHIL -100 TABLETS

NDA/MAL/HDP/8357 FRESENIUS PROPOVEN 1%

NDA/MAL/HDP/8252 PARACETAMOL FRESENIUS

NDA/MAL/HDP/0382 KETAMINE FRESENIUS

NDA/MAL/HDP/0435

NDA/MAL/HDP/0383 MANNITOL FRESENIUS

NDA/MAL/HDP/0437

NDA/MAL/HDP/0439

NDA/MAL/HDP/0444

NDA/MAL/HDP/0384

FOURTS(INDIA) LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

FREDUN PHARMACEUTICALS LTD

PLANET PHARMACEUTICALS UGANDA LTD

FREDUN PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

FREDUN PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED

SURGIPHARM (U) LIMITED

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

LIGNOCAINE HCL FRESENIUS

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED

SURGIPHARM (U) LIMITED

NALOXONE HCL NEONATAL FRESENIUS

FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED

SURGIPHARM (U) LIMITED

NALOXONE HCL FRESENIUS 0.4MG/1ML

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

NEOSTIGMINE METHYLSUIPHATE FRESENIUS

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

PANCURONIUM BROMIDE FRESENIUS

Page 121: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6058 FENTANYL FRESENIUS

NDA/MAL/HDP/6194 FENTANYL FRESENIUS

NDA/MAL/HDP/6195

NDA/MAL/HDP/6196

NDA/MAL/HDP/8204 DOPAMINE HCL FRESENIUS

NDA/MAL/HDP/4706 WIN-MEDICARE PVT LTD DICLOMOL GEL

NDA/MAL/HDP/7312

NDA/MAL/HDP/7335 BETADINE 5%

NDA/MAL/HDP/7381

NDA/MAL/HDP/4180 WIN-MEDICARE PVT LTD OSMOWIN

NDA/MAL/HDP/7336

NDA/MAL/HDP/2481 NETRACORT

NDA/MAL/HDP/1555 GALSCRUB

NDA/MAL/HDP/1550 RUBIGEL

NDA/MAL/HDP/2250 GALENTIC PHARMA LTD CANDIGEN

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

MORPHINE SULPHATE FRESENIUS

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

MORPHINE SULPHATE FRESENIUS

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

BETADINE OINTMENT 5%W/W

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

BETADINE ANTISEPTIC CREAM 5%

SURGIPHARM (U) LIMITED

MODI NUNDIPHARMA PVT LTD

SURGIPHARM (U) LIMITED

BETADINE GERMICIDE GARGLE 2% MINT

GALENTIC PHARMA (PVT)LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA( INDIA)PVT LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA( INDIA)PVT LTD

NORVIK ENTERPRISES LIMITED

NORVIK ENTERPRISES LIMITED

Page 122: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2362 CANDISTATIN OINTMENT

NDA/MAL/HDP/2080

NDA/MAL/HDP/2206 NETRA CORT

NDA/MAL/HDP/2211 BENZYL BENZOATE

NDA/MAL/HDP/2079 NETRAVIR

NDA/MAL/HDP/2248

NDA/MAL/HDP/3810 TRIOSPORINE OINTMENT

NDA/MAL/HDP/4614 GALENTIC PHARMA LTD

NDA/MAL/HDP/5507 GALENTIC PHARMA LTD CALADIN LOTION

NDA/MAL/HDP/1923 BETAMETHASONE

NDA/MAL/HDP/3252 PYLOOCAIN

NDA/MAL/HDP/6844 IDA FOUNDATION

NDA/MAL/HDP/0611 GALPHA LABORATORIES LTD AIVEEN (U) LIMITED GALCIPRO 500

NDA/MAL/HDP/1083 GALPHA LABORATORIES LTD AIVEEN (U) LIMITED CHOCOFER SYRUP

NDA/MAL/HDP/0827 GALPHA LABORATORIES LTD AIVEEN (U) LIMITED CLANOXY 1.2

GALENTIC PHARMA( INDIA)PVT LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA( INDIA)PVT LTD

NORVIK ENTERPRISES LIMITED

BETAMETHASONE VALERATE

GALENTIC PHARMA( INDIA)PVT LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA (PVT)LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA (PVT)LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA (PVT)LTD

NORVIK ENTERPRISES LIMITED

TETRACYCLINE OPHTHALMIC

GALENTIC PHARMA (PVT)LTD

NORVIK ENTERPRISES LIMITED

NORVIK ENTERPRISES LIMITED

COMPOUND BENZOIC ACID OINTMENT

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA (PVT)LTD

NORVIK ENTERPRISES LIMITED

GALENTIC PHARMA( INDIA)PVT LTD

NORVIK ENTERPRISES LIMITED

JOINT MEDICAL STORE (UPMB - UCMB)

BENZOIC ACID + SALICYLIC ACID

Page 123: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4014 FUSIGEN

NDA/MAL/HDP/4347 VERTIGON

NDA/MAL/HDP/5080 LOBAK

NDA/MAL/HDP/5448 FLUNER-5

NDA/MAL/HDP/3235 IDA FOUNDATION KIMSY MEDS LTD

NDA/MAL/HDP/8137 IDA FOUNDATION KIMSY MEDS LTD DIAZEPAM

NDA/MAL/HDP/4003 TATA (U) LTD TATA UGANDA LIMITED OXYTOCIN INJ

NDA/MAL/HDP/2041 IDA KIMSY MEDS LTD OXYTOCIN

NDA/MAL/HDP/8354 ZORUXA

NDA/MAL/HDP/5061 TATA (U) LTD TATA UGANDA LIMITED MAGNESIUM SULPHATE

NDA/MAL/HDP/4563 TATA (U) LTD TATA UGANDA LIMITED

NDA/MAL/HDP/4566 TATA (U) LTD TATA UGANDA LIMITED FUROSEMIDE INJECTION BP

NDA/MAL/HDP/5206 TATA (U) LTD TATA UGANDA LIMITED DIGOXIN INJECTION BP

NDA/MAL/HDP/5016 IDA FOUNDATION KIMSY MEDS LTD GENTAMYCIN INJECTION

NDA/MAL/HDP/2325 IDA FOUNDATION KIMSY MEDS LTD PARAMOMYCIN

NDA/MAL/HDP/2882 TATA (U) LTD TATA UGANDA LIMITED HYOSCINE BROMIDE

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTHCARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTH CARE INTERNATIONAL LTD

BETA HEALTHCARE UGANDA LIMITED

CHLORPROMAZINE INJECTION

MEGA LIFESCIENCES PUBLIC COMPANY LTD

ABACUS PHARMA (AFRICA) LIMITED

QUININE DIHYDROCHLORIDE INJECTION

Page 124: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1455 IDA KIMSY MEDS LTD

NDA/MAL/HDP/4773 IDA FOUNDATION KIMSY MEDS LTD METHYLERGOMETRINE

NDA/MAL/HDP/4810 TATA (U) LTD TATA UGANDA LIMITED METHYLERGONOVINE

NDA/MAL/HDP/2264 TATA (U) LTD TATA UGANDA LIMITED ARTEMETHER INJECTION

NDA/MAL/HDP/3230 GLAND PHARMA LIMITED TATA UGANDA LIMITED

NDA/MAL/HDP/3239 GLAND PHARMA LIMITED TATA UGANDA LIMITED

NDA/MAL/HDP/2736 IDA KIMSY MEDS LTD FUROSEMIDE

NDA/MAL/HDP/4153 TATA (U) LTD TATA UGANDA LIMITED DIAZEPAM INJECTION

NDA/MAL/HDP/6129 ERIS LTD TRIUMEQ

NDA/MAL/HDP/4062 ERIS LTD KIVEXA

NDA/MAL/HDP/4935 ERIS LTD BACTROBAN OINTMENT

NDA/MAL/HDP/4938 ERIS LTD BACTROBAN CREAM

NDA/MAL/HDP/1724 GLAXOSMITHKLINE LTD ERIS LTD AVAMYS NASAL SPRAY

NDA/MAL/HDP/6834 GLAXO SMITH KLINE LTD ERIS LTD RELVAR ELLIPTA 100/25

LIDOCAINE HCL 5% & DEXTROSE 7.5% INJECTION

METOCLOPRAMIDE INJECTIONTRAMADOL HYDROCHLORIDE

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXO SMITH KLEINE LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 125: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6836 GLAXO SMITH KLINE LTD ERIS LTD RELVAR ELLIPTA 200/25

NDA/MAL/HDP/8239 ERIS LTD UMBIPRO GEL

NDA/MAL/HDP/0204 ERIS LTD TIVICAY

NDA/MAL/HDP/5255 GLAXOSMITHKLINE LTD ERIS LTD ENO LEMONFRUIT SALT

NDA/MAL/HDP/4103 ERIS LTD

NDA/MAL/HDP/2869 GLAXO SMITHKLINE LTD ERIS LTD PRIORIX VACCINE

NDA/MAL/HDP/0903 ERIS LTD ZANTAC

NDA/MAL/HDP/4149 GLAXOSMITH KLINE LTD ERIS LTD TRACRIUM INJECTION

NDA/MAL/HDP/5020 ERIS LTD VENTOLIN

NDA/MAL/HDP/1936 GLAXO SMITH KLINE LTD ERIS LTD PIRITON EXPECTORANT

NDA/MAL/HDP/2051 GLAXO SMITH KLINE LTD ERIS LTD PIRITON TABLETS

NDA/MAL/HDP/4779 ERIS LTD CUTIVATE

NDA/MAL/HDP/4780 ERIS LTD CUTIVATE

NDA/MAL/HDP/3166 PHARMACARE LTD SEPTRIN

NDA/MAL/HDP/3434 PHARMACARE LIMITED SEPTRIN

NDA/MAL/HDP/1258 ERIS LTD MYOGLIN CAPSULES

NDA/MAL/HDP/0404 GLAXOSMITH KLINE LTD ERIS LTD

NDA/MAL/HDP/4310 GLAXOSMITHLINE LTD ERIS LTD ACTIFED SYRUP

NDA/MAL/HDP/2986 ERIS LTD OXYBRAL SR

NDA/MAL/HDP/3762 ERIS LTD LAMICTAL 2MG

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

POLIO SABIN - ONE AND THREE [ORAL]

GLAXO WELLCOME(KENYA) LTD

GLAXO WELLCOME (KENYA) LTD

GLAXO WELLCOME (KENYA) LTDGLAXO WELLCOME (KENYA) LTD

BETA HEALTHCARE UGANDA LIMITEDBETA HEALTHCARE UGANDA LIMITED

GLAXO WELLCOME(KENYA),LTD

ACTIFED WET COUGH & COLD

GLAXO WELLCOME(KENYA) LTDGLAXO WELLCOME (KENYA) LTD

Page 126: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4541 ERIS LTD AMOXIL

NDA/MAL/HDP/4722 GLAXO SMITHKLINE LTD ERIS LTD ACTIFED COLD TABLETS

NDA/MAL/HDP/4724 GLAXOSMITH KLINE LTD ERIS LTD

NDA/MAL/HDP/5018 ERIS LTD VENTOLIN

NDA/MAL/HDP/1673 ERIS LTD AMOXIL

NDA/MAL/HDP/6807 GLAXOSMITHKLINE LTD ERIS LTD AUGMENTIN ES

NDA/MAL/HDP/8474 GLAXOSMITH KLINE LTD ERIS LTD

NDA/MAL/HDP/1563 ERIS LTD AMOXIL

NDA/MAL/HDP/3285 ERIS LTD AMOXIL

NDA/MAL/HDP/1505 GLAXOSMITHKLINE ERIS LTD SERETIDE EVOHALER

NDA/MAL/HDP/4294 GLAXO SMITHLINE LIMITED ERIS LTD FLIXOTIDE ACCUHALER 250

NDA/MAL/HDP/4302 GLAXO SMITH KLINE LTD ERIS LTD FLIXOTIDE ACCUHALER 500

NDA/MAL/HDP/4339 GLAXOSMITHKLINE LIMITED ERIS LTD SERETIDE 125 EVOHALER

NDA/MAL/HDP/3530 GLAXO SMITH KLINE LTD ERIS LTD FLIXOTIDE ACCUHALER

NDA/MAL/HDP/1356 GLAXO SMITH KLINE LTD ERIS LTD REQUIP PD 24 HOUR 2 MG

NDA/MAL/HDP/1357 GLAXO SMITH KLINE LTD ERIS LTD REQUIP PD 24 HOUR 4 MG

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

ACTIFED DRY COUGH & COLD

GLAXO WELLCOME (KENYA) LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

AUGMENTIN SACHETS 1G/125MG

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 127: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4620 GLAXO SMITH KLINE LTD ERIS LTD

NDA/MAL/HDP/3460 ERIS LTD MALANIL ADULT TABLETS

NDA/MAL/HDP/0174 GLAXO SMITHKLINE LTD ERIS LTD FLIXOTIDE 50

NDA/MAL/HDP/0201 GLAXO SMITH KLINE LTD ERIS LTD FLIXOTIDE 125

NDA/MAL/HDP/4640 GLAXOSMITHLINE LTD ERIS LTD REQUIP PD 24 HOUR 8 MG

NDA/MAL/HDP/4085 ERIS LTD ZINACEF

NDA/MAL/HDP/0203 GLAXOSMITHLINE LTD ERIS LTD SERETIDE EVOHALER 250

NDA/MAL/HDP/1328 ERIS LTD ENGERIX-B VACCINE

NDA/MAL/HDP/1557 GLAXOSMITHKLINE ERIS LTD SYNFLORIX VACCINE

NDA/MAL/HDP/4289 GLAXOSMITHKLINE LTD ERIS LTD TWINRIX ADULT

NDA/MAL/HDP/5124 ERIS LTD INFANRIX-HEXA

NDA/MAL/HDP/1769 ERIS LTD ENGERIX-B VACCINE

NDA/MAL/HDP/2185 GLAXOSMITHKLINE LTD ERIS LTD ROTARIX

MALANIL PAEDIATRIC TABLET

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXO WELLCOME (KENYA) LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE LTD BELGIUM

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 128: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6810 ERIS LTD CERVARIX

NDA/MAL/HDP/4097 GLAXOSMITHKLINE LTD UK ERIS LTD DERMOVATE

NDA/MAL/HDP/5055 GLAXOSMITHKLINE LTD UK ERIS LTD DERMOVATE

NDA/MAL/HDP/1694 ERIS LTD BETNOVATE CREAM

NDA/MAL/HDP/2505 ERIS LTD BETNOVATE OINTMENT

NDA/MAL/HDP/3885 ERIS LTD ZANTAC

NDA/MAL/HDP/5004 COFTA TABLETS

NDA/MAL/HDP/3885 ERIS LTD ZANTAC

NDA/MAL/HDP/5004 COFTA TABLETS

NDA/MAL/HDP/3639 GLAXO SMITH KLINE LTD ERIS LTD PANADOL ADVANCE

NDA/MAL/HDP/1639 GLAXO SMITHLINE LIMITED ERIS LTD PANADOL EXTRA

NDA/MAL/HDP/3111 GLAXOSMITH KLINE LTD ERIS LTD CALPOL

NDA/MAL/HDP/1472 ERIS LTD FORTUM INJECTION

NDA/MAL/HDP/1768 ERIS LTD ULTIVA INJECTION 2MG

NDA/MAL/HDP/2003 ERIS LTD PROTEDEX 1G

NDA/MAL/HDP/2511 ERIS LTD ULTIVA INJECTION 3MG

NDA/MAL/HDP/3140 GLAXO SMITHKLINE LTD ERIS LTD ULTIVA INJECTION 1MG

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXO WELLCOME(KENYA),LTD

GLAXO WELLCOME(KENYA),LTD

GLAXO WELLCOME(KENYA) LTD

GLAXOSMITHKLINE LIMITED LIKONI

BETA HEALTHCARE UGANDA LIMITED

GLAXO WELLCOME(KENYA) LTD

GLAXOSMITHKLINE LIMITED LIKONI

BETA HEALTHCARE UGANDA LIMITED

GLAXO WELLCOME (KENYA) LTDGLAXO SMITHKLINE LTD(ITALY)GLAXO SMITHKLINE LTD(ITALY)GLAXO SMITHKLINE LTD(ITALY)

Page 129: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8149 GLAXO SMITHKLINE LTD ERIS LTD AVODART

NDA/MAL/HDP/1962 ERIS LTD NIMBEX

NDA/MAL/HDP/0275 GLAXO SMITHLINE LIMITED ERIS LTD ZENTEL

NDA/MAL/HDP/4380 ERIS LTD ZINNAT SUSPENSION

NDA/MAL/HDP/1985 ERIS LTD

NDA/MAL/HDP/2287 ERIS LTD ZINNAT

NDA/MAL/HDP/2568 ERIS LTD ZINNAT

NDA/MAL/HDP/3384 ERIS LTD PROXIMEXA 250MG

NDA/MAL/HDP/3387 ERIS LTD PROXIMEXA 500MG

NDA/MAL/HDP/3622 ERIS LTD PROXIMEXA

NDA/MAL/HDP/6490 SORVATE OINTMENT

NDA/MAL/HDP/6042 COMBIWAVE SF 125

NDA/MAL/HDP/6044 COMBIWAVE SF 50

GLAXO SMITHKLINE LTD(ITALY)

GLAXO WELLCOME (KENYA) LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

PROXIMEXA ORAL SUSPENSION 250MG/5ML

GLAXO WELLCOME (KENYA) LTDGLAXO WELLCOME (KENYA) LTDGLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD.

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD.

STAR PHARMACEUTICALS LTD

Page 130: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8322 GLEMONT L

NDA/MAL/HDP/6039 COMBIWAVE SF 250

NDA/MAL/HDP/0327 FLEXILOR 8

NDA/MAL/HDP/1244 FLEXILOR SR

NDA/MAL/HDP/0328 FLEXILOR P

NDA/MAL/HDP/1245 FLEXILOR P8

NDA/MAL/HDP/0854 IBICAR-50

NDA/MAL/HDP/0862 IBICAR- 200

NDA/MAL/HDP/1073 IBICAR-250

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

Page 131: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5397 IBICAR-100

NDA/MAL/HDP/5487 IBICAR-S

NDA/MAL/HDP/3527 AJANTA PHARMA LTD LEVOTOP-500

NDA/MAL/HDP/4957 MUMFER

NDA/MAL/HDP/5352 MUMFER

NDA/MAL/HDP/1099 MOMATE F CREAM

NDA/MAL/HDP/1417 MILICAL TABLETS

NDA/MAL/HDP/0857

NDA/MAL/HDP/1627 CANDID-V GEL

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD.

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

CANDID-V6 VAGINAL TABLETS

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

Page 132: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0510 LIZOLID-600

NDA/MAL/HDP/4855 ASCORIL EXPECTORANT

NDA/MAL/HDP/5150 KETO PLUS SHAMPOO

NDA/MAL/HDP/5170 CANDITRAL CAPSULE

NDA/MAL/HDP/1815 SUPIROCIN OINTMENT

NDA/MAL/HDP/1919 CANDIDERM CREAM

NDA/MAL/HDP/2008 CANDID -B- CREAM

NDA/MAL/HDP/2012 CANDID -B- LOTION

NDA/MAL/HDP/2016 CANDID CREAM

NDA/MAL/HDP/2173 GLEVO-500

NDA/MAL/HDP/2476 DERIVA AQUEOUS GEL

NDA/MAL/HDP/2553 ESOZ-20

NDA/MAL/HDP/2554 ESOZ

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD.

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD.

STAR PHARMACEUTICALS LTD

Page 133: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3204 RELCER GEL

NDA/MAL/HDP/3289 CANDID DUSTING POWDER

NDA/MAL/HDP/3291 FINTOP

NDA/MAL/HDP/3295 GLEVATE

NDA/MAL/HDP/3415 CANDID V-1

NDA/MAL/HDP/3545 CANDID MOUTH PAINT

NDA/MAL/HDP/6489 ASCORIL-SF

NDA/MAL/HDP/1246 GLEMONT CT 4

NDA/MAL/HDP/5079 GLEMONT CT 5

NDA/MAL/HDP/6048 MOMATE AZ

NDA/MAL/HDP/8232 MOMATE

NDA/MAL/HDP/1419 SINOPRIL 10

NDA/MAL/HDP/2293 TIOCON

NDA/MAL/HDP/3699 SINOPRIL 5MG TABLETS

NDA/MAL/HDP/3705 SORAL 20MG CAPSULES

NDA/MAL/HDP/7683 DELAREX

NDA/MAL/HDP/3903 PFIZER LABS LTD ERIS LTD CELSENTRI 300MG

NDA/MAL/HDP/6080 EXPHAR SA FEBRILEX JUNIOR

NDA/MAL/HDP/6081 EXPHAR SA ANTALGEX T

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICAL LTD.

STAR PHARMACEUTICALS LTD

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GLOBAL NAPI PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

GLOBAL NAPI PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

GLOBAL NAPI PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

GLOBAL NAPI PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

GLOBAL NAPI PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 134: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6523 EXPHAR SA. FLEXDOL

NDA/MAL/HDP/7023 EXPHAR SA. VERZOL ORAL SUSPENSION

NDA/MAL/HDP/7024 EXPHAR SA. MICOZAL

NDA/MAL/HDP/7269 EXPHAR SA. FEBRILEX SYRUP

NDA/MAL/HDP/6383 EXPHAR SA. EXXIB

NDA/MAL/HDP/5012 ROYAL GROUP GENTAMICIN INJECTION

NDA/MAL/HDP/0452 I CARE PHARMA LIMITED VITACARE LTD

NDA/MAL/HDP/0956 I CARE PHARMA LIMITED VITACARE LTD GENTAMICIN INJECTION BP

NDA/MAL/HDP/6921 DUFENAC

NDA/MAL/HDP/1278 D-ARTEPP

NDA/MAL/HDP/2529 G-CEFTRIA

NDA/MAL/HDP/6231 D-ARTEPP DISPERSIBLE

NDA/MAL/HDP/6242 D-ARTEPP

NDA/MAL/HDP/6436 MOXAF

NDA/MAL/HDP/1212 GLINTHER

NDA/MAL/HDP/4553 ARTESUN

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

HARLEYS UGANDA LIMITED

CALCIUM GLUCONATE INJECTION

GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

Page 135: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2055 ARTESUN

NDA/MAL/HDP/3566 ARTESUN

NDA/MAL/HDP/6234 D-ARTEPP

NDA/MAL/HDP/1035 G-CIPROX

NDA/MAL/HDP/1844

NDA/MAL/HDP/1861

NDA/MAL/HDP/5460 ARTESUN-PLUS

NDA/MAL/HDP/5483 ARTESUN-PLUS

NDA/MAL/HDP/2807 ARTESUN PLUS

NDA/MAL/HDP/1490

NDA/MAL/HDP/1272 MEBO HERBAL OINTMENT

NDA/MAL/HDP/5639 FEROMAX

NDA/MAL/HDP/6485 CEFUZIME 750

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICAL CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

SULFAMETHOXAZOLE / TRIMETHOPRIM

GUILIN PHARMACEUTICALS CO LTD

STAR PHARMACEUTICALS LTD

SULFAMETHOXAZOLE / TRIMETHOPRIM

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICALS CO.LTD

STAR PHARMACEUTICALS LTD

GUILIN PHARMACEUTICAL CO.LTD

STAR PHARMACEUTICALS LTD

METRONIDAZOLE TABLETS BP

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)

GAMA PHARMACEUTICALS (U) LIMITED

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GAMA PHARMACEUTICALS (U) LIMITED

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

Page 136: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6469 JUSPRIN 81 E/C TABLETS

NDA/MAL/HDP/6475 MOXAL SUSPENSION

NDA/MAL/HDP/6481

NDA/MAL/HDP/6483 MOXAL II SUSPENSION

NDA/MAL/HDP/6547

NDA/MAL/HDP/6561 RISEK

NDA/MAL/HDP/7030 ADOL EXTRA

NDA/MAL/HDP/7046 XEMADERM 0.1% CREAM

NDA/MAL/HDP/7047

NDA/MAL/HDP/7050 PANDERM SKIN OINTMENT

NDA/MAL/HDP/7051 DEXIPAN CREAM

NDA/MAL/HDP/8237 BCOOL

NDA/MAL/HDP/6471 CEFUZIME 500

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GAMA PHARMACEUTICALS (U) LIMITED

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

MOXAL PLUS CHEWABLE TABLETS

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

AMYDRAMINE PAEDIATRIC SYRUP

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GAMA PHARMACEUTICALS (U) LIMITED

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GAMA PHARMACEUTICALS (U) LIMITED

XEMADERM0.1% OINTMENT

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GAMA PHARMACEUTICALS (U) LIMITED

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GAMA PHARMACEUTICALS (U) LIMITED

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

Page 137: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6540 VANCOLON

NDA/MAL/HDP/6541 DIALON 1000 MG

NDA/MAL/HDP/6544 ORAMAX 150MG

NDA/MAL/HDP/7035 GLYPRIDE 3MG

NDA/MAL/HDP/8498 TRIAXONE 0.5G

NDA/MAL/HDP/5355 H.HOFFMAN ROCHE BONVIVA

NDA/MAL/HDP/0051 H. LUNDBECK A/S CLOPIXOL ACUPHASE

NDA/MAL/HDP/0055 H.LUNDBECK A/S CLOPIXOL DEPOT

NDA/MAL/HDP/0053 H. LUNDBECK A/S FLUANXOL DEPOT

NDA/MAL/HDP/8231 BENLE CONSULT LIMITED ANASTROZOLE DENK

NDA/MAL/HDP/4375 PFIZER LAB LTD ZITHROMAX

NDA/MAL/HDP/1948 ZITHROMAX

NDA/MAL/HDP/8063 UNASYN 1.5

NDA/MAL/HDP/3565 PFIZER LABS LIMITED UNASYN

NDA/MAL/HDP/6817 BENLE CONSULT LIMITED LETROZOLE DENK 2.5

NDA/MAL/HDP/1488 ERIS LTD BENLE CONSULT LIMITED DICLO-DENK 100 RECTAL

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR).

GOODMAN INTERNATIONAL LTD

GULF PHARMACEUTICAL INDUSTRIES(JULPHAR)

GOODMAN INTERNATIONAL LTD

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

DENK PARMA GMBH & CO. KG

LABOREX UGANDA LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD ITALY

LABOREX UGANDA LIMITEDLABOREX UGANDA LIMITED

DENK PARMA GMBH & CO. KG

Page 138: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8251 FUROTIL

NDA/MAL/HDP/5425 ROYAL GROUP PARACETAMOL

NDA/MAL/HDP/8292 METAPLUS (U) LIMITED PARACETAMOL

NDA/MAL/HDP/0303 HETERO LABS LTD ABACAVIR SULPHATE

NDA/MAL/HDP/5423 HETERO LABS LTD

NDA/MAL/HDP/5226 HETERO DRUGS LTD

NDA/MAL/HDP/0255 HETERO LABS LTD CAPETERO 150

NDA/MAL/HDP/0256 HETERO LABS LTD CAPETERO 500

NDA/MAL/HDP/8276 HETERO LABS LTD GEMTERO 1G

NDA/MAL/HDP/8277 HETERO LABS LTD GEMTERO 200MG

HEALTHCARE PHARMACEUTICALS LTD

ECHO PHARMACY (U) LIMITEDHARLEYS UGANDA LIMITED

META PRODUCTS UGANDA LTD

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITED

EFAVIRENZ+LAMIVUDINE+TENOFOVIR

ABACUS PHARMA (AFRICA) LIMITED

EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 139: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8406 HETERO LABS LTD UNIT IX PIOGEN45

NDA/MAL/HDP/0864 HETERO LABS LTD UNIT IX PANTIN-40

NDA/MAL/HDP/0867 HETERO LABS LTD UNIT IX PANTIN-20

NDA/MAL/HDP/0129 HETERO LABS LTD PIOGEN

NDA/MAL/HDP/6794 HETERO LABS LTD ZOLID

NDA/MAL/HDP/4123 HETERO LABS LTD UNIT VI NEVIRAPINE

NDA/MAL/HDP/4557 HETERO DRUGS LTD LAMIVUDINE

ASTRA PHARMA (U) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 140: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0798 HETERO LABS LTD AMLO-H 10

NDA/MAL/HDP/0267 HETERO LABS LTD PENVIR 750

NDA/MAL/HDP/0665 HETERO LABS LTD IRBIS-H 150

NDA/MAL/HDP/0666 HETERO LABS LTD IRBIS-H 300

NDA/MAL/HDP/0270 HETERO LABS LTD LEVIN 500MG

NDA/MAL/HDP/0898 HETERO LABS LTD LOSAGEN 50

NDA/MAL/HDP/0261 HETERO LABS LTD LOSAGEN -100

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 141: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4309 HETERO DRUGS LTD

NDA/MAL/HDP/2265 HETERO DRUGS LTD TENOFOVIR/ LAMUVIDINE

NDA/MAL/HDP/2291 HETERO DRUGS LTD VALOVIR

NDA/MAL/HDP/0704 HETERO LABS LTD UNIT IX M-FLOX

NDA/MAL/HDP/8274 HETERO LABS LTD BICATERO 50

NDA/MAL/HDP/8275 HETERO LABS LTD LETERO

NDA/MAL/HDP/5432 HETERO DRUGS LTD ZIDOVUDINE

ABACUS PHARMA (AFRICA) LIMITED

LAMIVUDINE + ZIDOVUDINE

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 142: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3613 HETERO LABS LTD

NDA/MAL/HDP/1915 HETERO LABS LTD

NDA/MAL/HDP/0707 HETERO LABS LTD PENVIR 500

NDA/MAL/HDP/5284 HETERO LABS LTD

NDA/MAL/HDP/0209 HETERO LABS LTD

NDA/MAL/HDP/8278 HETERO LABS LTD ANATERO

NDA/MAL/HDP/0796 HETERO LABS LTD AMLO-H 5

ABACUS PHARMA (AFRICA) LIMITED

ZIDOVUDINE ORAL SOLUTION

ABACUS PHARMA (AFRICA) LIMITED

ATAZANAVIR SULPHATE + RITONAVIR

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

EFAVIRENZ+EMTRICITABINE+TENOFOVIR

ABACUS PHARMA (AFRICA) LIMITED

ABACAVIR SULPHATE ORAL SOLUTION

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 143: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2011 HETERO LABS LTD SIFE 50

NDA/MAL/HDP/2111 HETERO LABS LTD LOPINAVIR / RITONAVIR

NDA/MAL/HDP/8227 HETERO LABS LTD ALZER 5

NDA/MAL/HDP/8339 SPECPHARM (PTY) LTD EFTENEM

NDA/MAL/HDP/0063 HETERO LABS LTD

NDA/MAL/HDP/0621 HETERO LABS LTD ALZER

NDA/MAL/HDP/0272 HETERO LABS LTD LEVIN 250

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACAVIR SULPHATE + LAMIVUDINE

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 144: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0894 HETERO LABS LTD GIAGRA 100

NDA/MAL/HDP/0618 HETERO LABS LTD VALSAR 160

NDA/MAL/HDP/0301 HETERO LABS LTD MONTE - H 10

NDA/MAL/HDP/0085 HETERO LABS LTD UNIT IX PIOGEN-30

NDA/MAL/HDP/0615 HETERO LABS LTD VALSAR 80

NDA/MAL/HDP/0304 HETERO LABS LTD DARUNAVIR

NDA/MAL/HDP/0426 HETERO LABS LTD

NDA/MAL/HDP/0855 HETERO LABS LTD LAZINE

NDA/MAL/HDP/0696 HETERO LABS LTD RITONAVIR

NDA/MAL/HDP/1178 HETERO DRUGS LTD TENOFOVIR

NDA/MAL/HDP/6237 HETERO LABS LTD LOPINAVIR/RITONAVIR

NDA/MAL/HDP/7660 SPECPHARM (PTY) LTD TENEMCOM

NDA/MAL/HDP/4047 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. NEOGAB

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITED

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

ABACUS PHARMA (AFRICA) LIMITEDABACUS PHARMA (AFRICA) LIMITEDASTRA PHARMA (U) LIMITEDABACUS PHARMA (AFRICA) LIMITEDPHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 145: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4336 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. NEOGAB

NDA/MAL/HDP/4763 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. FEROSOFT

NDA/MAL/HDP/4765 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. FEROSOFT-FA

NDA/MAL/HDP/5045 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. MAXIT TABLETS

NDA/MAL/HDP/5190 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. HICLOR

NDA/MAL/HDP/5198 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. HICLOR

NDA/MAL/HDP/5366 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. CEFIM

NDA/MAL/HDP/5367 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. CEFIM

NDA/MAL/HDP/2128 HILTON PHARMA (PVT) LTD HEALTHCARE LTD.

NDA/MAL/HDP/2386 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. NEOGAB

NDA/MAL/HDP/2575 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. MYTEKA

NDA/MAL/HDP/3277 HILTON PHARMA (PVT) LTD HEALTHCARE LTD.

NDA/MAL/HDP/4760 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. FEROSOFT

NDA/MAL/HDP/5387 HILTON PHARMA (PVT) LTD HEALTHCARE LTD.

NDA/MAL/HDP/2820 HILTON PHARMA (PVT) LTD HEALTHCARE LTD.

NDA/MAL/HDP/3301 HILTON PHARMA (PVT) LTD HEALTHCARE LTD. TRANSAMIN CAPSULES 250

NDA/MAL/HDP/4091 HILTON PHARMA PVT LTD HEALTHCARE LTD. MYTEKA TABLETS

NDA/MAL/HDP/3730 BAYER PHARMA AG AVELOX

NDA/MAL/HDP/4055 BAYER PHARMA AG BAYER ASPIRIN CARDIO

NDA/MAL/HDP/4187 BAYER PHARMA AG NORIGYNON

NDA/MAL/HDP/4901 BAYER PHARMA AG AVELOX IV

NDA/MAL/HDP/0981 HOVID BHD CLOFENAC SR TABLETS

TRANSAMIN INJECTION 500MG

TRANSAMIN CAPSULES 500MG

TRANSAMIN INJECTION 250MG

VALODIN 500MG CAPSULES

SURGIPHARM (U) LIMITEDSURGIPHARM (U) LIMITED

STAR PHARMACEUTICALS LTDSURGIPHARM (U) LIMITEDUNITED HEALTHCARE DISTRIBUTORS LTD

Page 146: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1301 HOVID BHD COSAMINE PLUS

NDA/MAL/HDP/5449 HOVID BHD CLOFENAC 50

NDA/MAL/HDP/7070 HOVID BHD

NDA/MAL/HDP/7356 HOVID BHD DIABETMIN TABLET 500MG

NDA/MAL/HDP/0006 HOVID BHD DIAMIDE

NDA/MAL/HDP/1383 HOVID BHD KETOFEN GEL

NDA/MAL/HDP/0014 HOVID BHD (IPOH SITE) MONTELAIR 10MG TABLET

NDA/MAL/HDP/1298 HOVID BHD NEUROVIT FORTE

NDA/MAL/HDP/7711 HOVID BHD DIABETMIN 850 MG

NDA/MAL/HDP/0353 HOVID BHD DEROX-10

NDA/MAL/HDP/1104 HOVID BHD LIPIDUCE 10

NDA/MAL/HDP/6132 HOVID BHD KETOVID

NDA/MAL/HDP/6203 HOVID BHD DEROX-5

NDA/MAL/HDP/3145 HOVID BHD AMOXICAP

NDA/MAL/HDP/6771 HOVID BHD DIFLUVID

NDA/MAL/HDP/7053 HOVID BHD KETOVID CREAM

NDA/MAL/HDP/7055 HOVID BHD VIREST 400

NDA/MAL/HDP/7057 HOVID BHD VIREST CREAM 5%

NDA/MAL/HDP/0065 HOVID BHD ALENDRONATE 70MG

NDA/MAL/HDP/1382 HOVID BERHAD INOX CAPSULES

NDA/MAL/HDP/0012 HOVID BHD PENGESIC SR

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

DIABETMIN 1000 MG FILM-COATED TABLET

UNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTDUNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 147: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5144 HOVID BHD KETOCONAZOLE 200MG

NDA/MAL/HDP/2089 HOVID BHD DIABETMIN XR 500MG

NDA/MAL/HDP/3112 HOVID BHD BUPROL 400MG

NDA/MAL/HDP/6256 HOVID BHD (IPOH SITE) AZIMAX- 250

NDA/MAL/HDP/7063 HOVID BHD

NDA/MAL/HDP/7571 HOVID BHD

NDA/MAL/HDP/0555 HOVID BHD CARZEPIN

NDA/MAL/HDP/0559 HOVID BHD DIABETMIN RETARD

NDA/MAL/HDP/6754 TATA UGANDA LIMITED ABHAYRAB

NDA/MAL/HDP/6217 TATA UGANDA LIMITED ELOVAC -B

NDA/MAL/HDP/6121 CORE ACCESS LTD DEXIREN

NDA/MAL/HDP/7293 CORE ACCESS LTD ALRINAST

NDA/MAL/HDP/7364 CORE ACCESS LIMITED MOKSEFEN 400 MG

NDA/MAL/HDP/7716 CORE ACCESS LIMITED CORE ACCESS LTD

NDA/MAL/HDP/8348 CORE ACCESS LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

GRISEOFULVIN 500MG FILM-COATED TABLET

UNITED HEALTHCARE DISTRIBUTORS LTD

NEUROVIT FILM-COATED TABLET

UNITED HEALTHCARE DISTRIBUTORS LTDMEDICAL ACCESS (UGANDA) LIMITED

INDIAN IMMUNOLOGICALS LIMITED

INDIAN IMMUNOLOGICALS LTD

İLKO İLAÇ SANAYI VE TICARET A. Ş.

İLKO İLAÇ SANAYI VE TICARET A. Ş.

İLKO İLAÇ SANAYI VE TICARET A. Ş.

ALRINAST 2.5 MG / 5 ML SYRUP

İLKO İLAÇ SANAYI VE TICARET A. Ş.

IRBECOR PLUS 300MG/12.5MG

Page 148: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8392 CORE ACCESS LIMITED

NDA/MAL/HDP/4392 IND SWIFT LTD TATA UGANDA LIMITED CAPLOR

NDA/MAL/HDP/2204 IND SWIFT LTD TATA UGANDA LIMITED ATSTAT

NDA/MAL/HDP/0337 IND-SWIFT TATA UGANDA LIMITED SWAZI *500

NDA/MAL/HDP/0339 IND-SWIFT TATA UGANDA LIMITED SWAZI *250

NDA/MAL/HDP/0341 IND SWIFT LTD TATA UGANDA LIMITED TELSWIFT- H 40

NDA/MAL/HDP/0342 IND SWIFT LTD TATA UGANDA LIMITED TELSWIFT- H 80

NDA/MAL/HDP/7359 TATA UGANDA LIMITED INDCLAV 625

NDA/MAL/HDP/0236 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED CLOB

NDA/MAL/HDP/4297 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED CLOBEN-G

NDA/MAL/HDP/2373 INDOCO REMEDIES LTD TATA UGANDA LIMITED CLOBEN SKIN CREAM

NDA/MAL/HDP/1899 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED

NDA/MAL/HDP/3054 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED NOSIC

NDA/MAL/HDP/6755 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED FLAMAR

NDA/MAL/HDP/4596 INDOCO REMEDIES LTD TATA UGANDA LIMITED TRIZ TABLETS

NDA/MAL/HDP/6534 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED REXIDIN

NDA/MAL/HDP/8164 INDOCO REMEDIES LTD TATA UGANDA LIMITED ATM 200

NDA/MAL/HDP/1583 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED ABZEE

NDA/MAL/HDP/0738 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED CIPRIND-500

NDA/MAL/HDP/3806 INDOCO REMEDIES LTD TATA UGANDA LIMITED NOCID GEL

İLKO İLAÇ SANAYI VE TICARET A. Ş.

IRBECOR PLUS 150MG/12.5MG

INDCHEMIE HEALTH SPECIALITIES PVT. LTD.

TUSPRESS COUGH SUPPRESSANT

Page 149: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4134 INDOCO REMEDIES LTD TATA UGANDA LIMITED CITAL

NDA/MAL/HDP/4825 INDOCO REMEDIES LTD TATA UGANDA LIMITED ALOHA LIQUID

NDA/MAL/HDP/1838 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED ABZEE

NDA/MAL/HDP/2194 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED CALCIUM D SYRUP

NDA/MAL/HDP/2376 INDOCO REMEDIES LTD TATA UGANDA LIMITED METCHEK-500

NDA/MAL/HDP/2405 INDOCO REMEDIES LTD TATA UGANDA LIMITED ERYTHROMYCIN STEARATE

NDA/MAL/HDP/3043 INDOCO REMEDIES LTD TATA UGANDA LIMITED FEBREX TABLETS

NDA/MAL/HDP/3280 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED

NDA/MAL/HDP/6748 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED IBUFLAMAR 200

NDA/MAL/HDP/6749 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED IBUFLAMAR-P

NDA/MAL/HDP/6751 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED METCHEK 850

NDA/MAL/HDP/6757 INDOCO REMEDIES LIMITED TATA UGANDA LIMITED OSTEOFLAM

NDA/MAL/HDP/6781 IND-SWIFT LTD TATA UGANDA LIMITED NETAZOX-500

NDA/MAL/HDP/6785 IND-SWIFT LTD TATA UGANDA LIMITED NETAZOX DT

NDA/MAL/HDP/6787 IND-SWIFT LTD TATA UGANDA LIMITED NETAZOX

NDA/MAL/HDP/0563 IND SWIFT LTD TATA UGANDA LIMITED EZO 40

NDA/MAL/HDP/5243 IND SWIFT LTD TATA UGANDA LIMITED EZO 20

NDA/MAL/HDP/1705 IND-SWIFT TATA UGANDA LIMITED METSWIFT

NDA/MAL/HDP/2205 IND SWIFT LTD TATA UGANDA LIMITED C-SWIFT

NDA/MAL/HDP/2600 IND SWIFT LTD TATA UGANDA LIMITED CLARIE-OD

NDA/MAL/HDP/3642 IND-SWIFT TATA UGANDA LIMITED CLARIE 250

TUSPEL PLUS EXPECTORANT

Page 150: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8309 INDUS PHARMA PVT LTD HEALTHCARE LTD. SNOLIP 20MG

NDA/MAL/HDP/8310 INDUS PHARMA PVT LTD HEALTHCARE LTD. MAXPAN-100

NDA/MAL/HDP/0899 VIRIAXONE

NDA/MAL/HDP/8649 MATRIX (U) LIMITED CEFCARE

NDA/MAL/HDP/0706 ROVAS 5

NDA/MAL/HDP/0710 ROVAS 20

NDA/MAL/HDP/1431 TORTAS 10

NDA/MAL/HDP/3707 OBETAS-120

NDA/MAL/HDP/6491 PREGATAS ME 75

NDA/MAL/HDP/1574 AMTAS-5

NDA/MAL/HDP/0598 LIPICURE-20

NDA/MAL/HDP/4606 ROVAS 10

NDA/MAL/HDP/5232 ENAPRIL-5

NDA/MAL/HDP/5245 FABUTAS-40

NDA/MAL/HDP/5269 DIVAA OD 500

NDA/MAL/HDP/5406 HIFENAC SR

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

INJECTCARE PARENTERALS PVT. LTDINTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACUITICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

Page 151: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1798 CARDITAS RETARD

NDA/MAL/HDP/2176 RISPITAS-2

NDA/MAL/HDP/2692 RAMITAS 5

NDA/MAL/HDP/2781 CARVETAS 6.25

NDA/MAL/HDP/3007 TORTAS 5

NDA/MAL/HDP/3612 LOSARTAS-HT

NDA/MAL/HDP/3947 RABTAS-20

NDA/MAL/HDP/3871 DOVERIN 40

NDA/MAL/HDP/2782 KWINIL

NDA/MAL/HDP/2873 HELIGO KIT

NDA/MAL/HDP/7481 ACCORD HEALTH CARE LTD SILDENAFIL ACCORD 100

NDA/MAL/HDP/7488 ACCORD HEALTH CARE LTD FINASTERIDE 5MG

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACUITICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACUITICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

NORVIK ENTERPRISES LIMITED

NORVIK ENTERPRISES LIMITED

Page 152: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7490 ACCORD HEALTH CARE LTD SILDENAFIL ACCORD 50

NDA/MAL/HDP/8407 TORTAS 20

NDA/MAL/HDP/1387 LAN-30

NDA/MAL/HDP/1335 PREGATAS

NDA/MAL/HDP/3854 LOSARTAS 50 TABLETS

NDA/MAL/HDP/2438 HIFENAC

NDA/MAL/HDP/1050 AMTAS-10

NDA/MAL/HDP/1799 SECZOL DS

NDA/MAL/HDP/5231 ENAPRIL 10

NDA/MAL/HDP/1629 CARVETAS 12.5

NDA/MAL/HDP/5404 HIFENAC P

NDA/MAL/HDP/0743 TRY-PZ

NDA/MAL/HDP/1400 PANFOR SR 500

NDA/MAL/HDP/1402 PANFOR SR 1000

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LIMITED

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTAS, PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

INTRACIN PHARMACEUTICAL PVT LTD

VEERAM HEALTHCARE (U) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

Page 153: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6621 BAROLE 20

NDA/MAL/HDP/6790 LIMZER

NDA/MAL/HDP/1330 IPCA LABORATORIES LTD RAPICLAV-625

NDA/MAL/HDP/3816 IPCA LABORATORIES LTD RAPICLAV-375

NDA/MAL/HDP/6388 IPCA LABORATORIES LTD RAPICLAV 250 DT

NDA/MAL/HDP/3973 LARITHER

NDA/MAL/HDP/5388 IPCA LABORATORIES LTD LARINATE

NDA/MAL/HDP/3656 IPCA LABORATORIES LTD LARITEM

NDA/MAL/HDP/1239 IPCA LABORATORIES LTD PECTYLIN-C

NDA/MAL/HDP/1922 AZIFAST-500

NDA/MAL/HDP/3108 IPCA LABORATOIES LTD ZERODOL

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

SURGIPHARM (U) LIMITED

IPCA LABORATORIES LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

IPCA LABORATORIES LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

Page 154: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3205 EAGLEVET UGANDA LIMITED AZIFAST-250

NDA/MAL/HDP/7670 IPCA LABORATORIES LTD DICHLOR 50

NDA/MAL/HDP/7671 IPCA LABORATORIES LTD DICHLOR-25

NDA/MAL/HDP/7334 IPCA LABORATORIES LTD ETOVA 400

NDA/MAL/HDP/1390 ASTRA ZENECA MACNAUGHTON LIMITED CRESTOR

NDA/MAL/HDP/4617 ASTRA ZENECA MACNAUGHTON LIMITED CRESTOR

NDA/MAL/HDP/4645 ASTRA ZENECA MACNAUGHTON LIMITED CRESTOR

NDA/MAL/HDP/2081 IVEE INFUSIONS EPZ LTD

NDA/MAL/HDP/1420 IVEE INFUSIONS EPZ LTD

NDA/MAL/HDP/6775 IVEE INFUSIONS EPZ LTD IVYSOLONE

NDA/MAL/HDP/6780 IVEE INFUSIONS EPZ LTD IVYTIMOL

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

SURGIPHARM (U) LIMITED

ASTRA PHARMA (U) LIMITED

COMPOUND SODIUM LACTATE

ASTRA PHARMA (U) LIMITED

SODIUM CHLORIDE + GLUCOSE

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

Page 155: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6782 IVEE INFUSIONS EPZ LTD IVYXOLOL

NDA/MAL/HDP/6784 IVEE INFUSIONS EPZ LTD IVYZOXAN

NDA/MAL/HDP/5191 IVEE INFUSIONS EPZ LTD IVYBETASONE EYE DROPS

NDA/MAL/HDP/6370 IVEE INFUSIONS EPZ LTD IVYCROM EYE DROPS

NDA/MAL/HDP/6372 ASTRA PHARMA (U) LTD IVYTIMOL EYE DROPS

NDA/MAL/HDP/0402 IVEE AQUA EPZ LTD

NDA/MAL/HDP/4084 IVEE INFUSIONS EPZ LTD WATER FOR INJECTION

NDA/MAL/HDP/5192 IVEE INFUSIONS EPZ LTD

NDA/MAL/HDP/5193 IVEE INFUSIONS EPZ LTD IVYDEXNEOCIN EYE DROPS

NDA/MAL/HDP/5194 IVEE INFUSIONS EPZ LTD IVYDEXONE EYE DROPS

NDA/MAL/HDP/5195 IVEE INFUSIONS EPZ LTD IVYFRIN P NASAL DROPS

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

IVYSONE OPHTHALMIC SUSPENSION

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

IVYDEXGENT EYE/EAR DROPS

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

Page 156: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5196 IVEE INFUSIONS EPZ LTD IVYFRIN NASAL DROPS

NDA/MAL/HDP/5197 IVEE INFUSIONS EPZ LTD

NDA/MAL/HDP/6128 IVEE INFUSIONS EPZ LTD IVYFLUR

NDA/MAL/HDP/6130 ASTRA PHARMA (U) LIMITED IVYSINE EYE DROPS

NDA/MAL/HDP/2241 IVEE AQUA EPZ LTD IVYPHENOCOL EYE DROPS

NDA/MAL/HDP/2244 IVEE INFUSIONS EPZ LTD IVYDEXNICOL EYE DROPS

NDA/MAL/HDP/2370 IVEE AQUA EPZ LTD

NDA/MAL/HDP/2799 IVEE AQUA EPZ LTD

NDA/MAL/HDP/3654 IVEE AQUA EPZ LTD

NDA/MAL/HDP/5014 TATA UGANDA LIMITED VERMOREX SUSPENSION

NDA/MAL/HDP/1992 TATA UGANDA LIMITED UNIKPEF

NDA/MAL/HDP/2270 TATA UGANDA LIMITED ZITHROCIN 500

NDA/MAL/HDP/5215 TATA UGANDA LIMITED METROGYL TABLETS

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

IVYGENTACIN EYE/EAR DROP

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

IVYBETANEOCIN EYE DROPS

ASTRA PHARMA (U) LIMITED

IVYCHLORNICOL EAR DROPS

ASTRA PHARMA (U) LIMITED

IVYNOZVIN A NASAL DROPS

UNIQUE PHARMACEUTICAL LABORATORIES

UNIQUE PHARMACEUTICAL LABORATORIES

UNIQUE PHARMACEUTICAL LABORATORIES

J.B CHEMICALS & PHARMACEUTICALS LTD

Page 157: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1994 TATA UGANDA LIMITED PANUM 40

NDA/MAL/HDP/3882 TATA UGANDA LIMITED PEDIVIT FORTE CAPSULES

NDA/MAL/HDP/8143 NAARI AG LYDIA POSTPIL

NDA/MAL/HDP/6257 EDURANT

NDA/MAL/HDP/4389 PHARMACARE LTD PREZISTA

NDA/MAL/HDP/6792 PREZISTA

NDA/MAL/HDP/7337 PREZISTA 150

NDA/MAL/HDP/8315 PREZISTA 75

NDA/MAL/HDP/0364 JASSEN-CILAG (PTY) LTD HALDOL

NDA/MAL/HDP/3720 JASSEN-CILAG (PTY) LTD HALDOL DECANOAS

NDA/MAL/HDP/5181 JASSEN-CILAG (PTY) LTD GYNO-DAKTARIN OVULES

NDA/MAL/HDP/6127 INTELENCE

NDA/MAL/HDP/6169 INTELENCE

NDA/MAL/HDP/4937 JASSEN-CILAG (PTY) LTD MOTILIUM

NDA/MAL/HDP/5412 TATA UGANDA LIMITED IFICIPRO 250

NDA/MAL/HDP/0368

NDA/MAL/HDP/7682 ABACUS PHARMA (A) LTD. AB-TETRA-250

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

ECHO PHARMACY (U) LIMITED

JANSSEN-CILAG INTERNATIONAL NV

MEDICAL ACCESS (UGANDA) LIMITEDMEDICAL ACCESS (UGANDA) LIMITED

JANSSEN-CILAG INTERNATIONAL NV

MEDICAL ACCESS (UGANDA) LIMITED

JANSSEN-CILAG INTERNATIONAL NV

MEDICAL ACCESS (UGANDA) LIMITED

JANSSEN-CILAG INTERNATIONAL NV

MEDICAL ACCESS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

JANSSEN-CILAG INTERNATIONAL NV

MEDICAL ACCESS (UGANDA) LIMITED

JANSSEN-CILAG INTERNATIONAL NV

MEDICAL ACCESS (UGANDA) LIMITEDLABOREX UGANDA LIMITED

UNIQUE PHARMACEUTICAL LABORATORIES

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

QUININE DI HYDROCHLORIDE INJECTION

ABACUS PHARMA (AFRICA) LIMITED

Page 158: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0302 ABACUS PHARMA LTD CINAMET-400

NDA/MAL/HDP/3834 ROYAL GROUP TETRACYCLINE

NDA/MAL/HDP/6096 ABACUS PHARMA (A) LTD. ABGYL-200

NDA/MAL/HDP/1819 ABACUS PHARMA (A) LTD. CINAMET-200

NDA/MAL/HDP/5446 ABACUS PHARMA LTD PHENICOL- 250

NDA/MAL/HDP/1188 ABACUS PHARMA (A) LTD. GMYCIN-80

NDA/MAL/HDP/0989 ROYAL GROUP DICLOFENAC SODIUM

NDA/MAL/HDP/0561 ABACUS PHARMA (A) LTD. FALCIMAX-600

NDA/MAL/HDP/0561 ABACUS PHARMA (A) LTD. FALCIMAX-600

NDA/MAL/HDP/5390 ROYAL GROUP ARTEMETHER INJECTION

NDA/MAL/HDP/7687 DI - QUIN

NDA/MAL/HDP/8323 NEOPROFANE 400

NDA/MAL/HDP/0998 ROYAL GROUP

ABACUS PHARMA (AFRICA) LIMITED

HARLEYS UGANDA LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

HARLEYS UGANDA LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

HARLEYS UGANDA LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

MOONLINK PHARMACEUTICALS LTD

MOONLINK PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

QUININE DIHYDROCHLORIDE INJECTION

Page 159: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1189 ABACUS PHARMA (A) LTD. DICLOMAX-75

NDA/MAL/HDP/0300 ABACUS PHARMA LTD AB-DOX-100

NDA/MAL/HDP/1764 FRESH BURST LISTERINE

NDA/MAL/HDP/3464

NDA/MAL/HDP/1510 LISTERINE ANTISEPTIC

NDA/MAL/HDP/4033

NDA/MAL/HDP/4949 BENYLIN DRY COUGH DM

NDA/MAL/HDP/4951 BENYLIN ORIGINAL

NDA/MAL/HDP/4952 BENYLIN WITH CODEINE

NDA/MAL/HDP/4972 COOLMINT LISTERINE

NDA/MAL/HDP/5377 BENYLIN FOUR FLU LIQUID

NDA/MAL/HDP/2321 BENYLIN CHESTY

NDA/MAL/HDP/3078

NDA/MAL/HDP/3156 PFIZER LABORATORIES (PTY) BENYLIN FOR COLDS

NDA/MAL/HDP/3413 COMBANTRIN

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

JOHNSON &JOHNSON (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON &JOHNSON (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

TARTAR CONTROL LISTERINE ANTISEPTIC

JOHNSON &JOHNSON (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

BENYLIN PAEDIATRIC SYRUP

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON &JOHNSON (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

SINUTAB ALLERGY CONGESTION

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON &JOHNSON (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 160: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3483 SINUTAB 3-WAY

NDA/MAL/HDP/0950 EPOTIN

NDA/MAL/HDP/0949 VANCOLON

NDA/MAL/HDP/1570 KAM AMOXY

NDA/MAL/HDP/0388 AZUCLOX

NDA/MAL/HDP/0562 KAM COTRI

NDA/MAL/HDP/0043 KAMADOL JUNIOR

NDA/MAL/HDP/3812 B-TONE

NDA/MAL/HDP/4010 PYRI

NDA/MAL/HDP/4043 KAM AMPI

NDA/MAL/HDP/4569 KAMADOL SYRUP

NDA/MAL/HDP/5248 KAM-AMPI

JOHNSON&JOHNSON PTY LTD. 241

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JULPHAR GULF PHARMACEUTICAL INDUSTRIES

GAMA PHARMACEUTICALS (U) LIMITED

JULPHAR GULF PHARMACEUTICAL INDUSTRIES

GAMA PHARMACEUTICALS (U) LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

Page 161: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5260 ERYMYCIN

NDA/MAL/HDP/1701 FORMIN

NDA/MAL/HDP/1886 KAM QUIN TABLETS

NDA/MAL/HDP/1887 KAMADOL

NDA/MAL/HDP/1889 KAM PREDSOL

NDA/MAL/HDP/2020 QUINE

NDA/MAL/HDP/2035 NEOSIDAR

NDA/MAL/HDP/2177 KAM ERYMYCIN

NDA/MAL/HDP/2180 KAM PEN V

NDA/MAL/HDP/2181 KAM PHEN

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

Page 162: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2184 KAM QUIN MIXTURES

NDA/MAL/HDP/2440 KAMADOL KIDS

NDA/MAL/HDP/3236 KAM COTRI

NDA/MAL/HDP/3273 BETASOL CREAM

NDA/MAL/HDP/3361 AZUCLOX

NDA/MAL/HDP/6752 VITACEE

NDA/MAL/HDP/8080 CEFTONE

NDA/MAL/HDP/8089 KAM-AMOXY

NDA/MAL/HDP/4933 AZUDOX

NDA/MAL/HDP/1960 DIFENAC

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

Page 163: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8085 CIPROL-500

NDA/MAL/HDP/0627 AMOXIKID

NDA/MAL/HDP/1359 DIFENAC-100 SR

NDA/MAL/HDP/3741 ACTIZINE

NDA/MAL/HDP/3974 KAMCLOXA

NDA/MAL/HDP/1888 KAM QUIN SYRUP

NDA/MAL/HDP/2707 KAMCLOXA

NDA/MAL/HDP/3839 FLURID

NDA/MAL/HDP/5205 KAM-VENT

NDA/MAL/HDP/1842 SUGAQUIN TABLETS

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

Page 164: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1018 KAM CHLOR

NDA/MAL/HDP/1380 HYCORT CREAM

NDA/MAL/HDP/0580 FLUCAP

NDA/MAL/HDP/3735 KAMSPRO

NDA/MAL/HDP/3924 FLUFED

NDA/MAL/HDP/4369 FLUCAP

NDA/MAL/HDP/4892 FLUFED COUGH FORMULA

NDA/MAL/HDP/5201 KAM BENDAZOLE

NDA/MAL/HDP/5203 KAM METRO

NDA/MAL/HDP/5204 KAM METRO

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

Page 165: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5467 KAMSIDAR

NDA/MAL/HDP/5566 HYCORT OINTMENT

NDA/MAL/HDP/1902 KAMODIUM

NDA/MAL/HDP/3224 KAM FLUFED ELIXIR

NDA/MAL/HDP/3325 RAPIDEX

NDA/MAL/HDP/6750 NYTIN

NDA/MAL/HDP/3845 CARDIPAC

NDA/MAL/HDP/3144 ULSEC

NDA/MAL/HDP/3443 BETASOL OINTMENT

NDA/MAL/HDP/3738 TATA UGANDA LIMITED AMPICILLIN SODIUM

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD

Page 166: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4546 TATA UGANDA LIMITED

NDA/MAL/HDP/5648 TATA UGANDA LIMITED CLOXACILLIN SODIUM

NDA/MAL/HDP/1797 TATA UGANDA LIMITED AMPICILLIN+CLOXACILLIN

NDA/MAL/HDP/3117 TATA UGANDA LIMITED

NDA/MAL/HDP/8419 VB COMPLEX

NDA/MAL/HDP/0333 KOPRAN LIMITED TATA UGANDA LIMITED CLAVAMYN-625

NDA/MAL/HDP/0024 KOPRAN LIMITED TATA UGANDA LIMITED AMPICLOXA

NDA/MAL/HDP/1300 KOPRAN LIMITED TATA UGANDA LIMITED ATENOLOL-100

NDA/MAL/HDP/0354 KOPRAN LIMITED TATA UGANDA LIMITED LEVOKOP

NDA/MAL/HDP/0338 KOPRAN LIMITED TATA UGANDA LIMITED KORAB 20

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD

CHLORAMPHENICOL INJECTION IG

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD

HYDROCORTISONE SODIUM SUCCINATE

ROYAL PHARMA 2011 LIMITED

ROYAL PHARMA 2011 LIMITED

Page 167: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4922 KOPRAN LIMITED TATA UGANDA LIMITED CIPROQUIN-500

NDA/MAL/HDP/1711 KOPRAN LIMITED TATA UGANDA LIMITED AMYN-250

NDA/MAL/HDP/1795 KOPRAN LIMITED TATA UGANDA LIMITED AMPIK-250

NDA/MAL/HDP/1894 KOPRAN LIMITED TATA UGANDA LIMITED TRIM-480

NDA/MAL/HDP/0228 KOPRAN LIMITED TATA UGANDA LIMITED TRIM-960

NDA/MAL/HDP/1676 KOPRAN LIMITED TATA UGANDA LIMITED CLOXIN-250

NDA/MAL/HDP/6746 KOPRAN LTD TATA UGANDA LIMITED FLUPEN-250

NDA/MAL/HDP/7015 KOPRAN LIMITED TATA UGANDA LIMITED LOKIT

NDA/MAL/HDP/8319 KOPRAN LIMITED TATA UGANDA LIMITED ERYKO-250

NDA/MAL/HDP/1342 AXCEL CEPHALEXIN 250KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 168: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1554 AXCEL CETIRIZINE

NDA/MAL/HDP/0678

NDA/MAL/HDP/0671 AXCEL LIGNOCAINE

NDA/MAL/HDP/0571 AXCEL KAOPEC

NDA/MAL/HDP/0667 AXEL MICONAZOLE

NDA/MAL/HDP/0573 AXCEL PARACETAMOL-250

NDA/MAL/HDP/0569 KOTRA PHARMA SDN BDN AXCELLRIDIN LINCTUS

NDA/MAL/HDP/3927 AXCEL CEPHALEXIN 125

NDA/MAL/HDP/4917

NDA/MAL/HDP/4919

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL HYDROCORTISONE CREAM

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL EVILINE FORTE SUSPENSION

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL FUSIDIC ACID- B CREAM

Page 169: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5422 VAXCEL CEFUROXIME-750

NDA/MAL/HDP/5441 AXCEL NASATAB TABLETS

NDA/MAL/HDP/2178 AXCEL CEFUROXIME-250

NDA/MAL/HDP/2189 AXCEL BETAMETHASONE

NDA/MAL/HDP/2208 KOTRA PHARMA SDN BDN AXCEL CEPHALEXIN

NDA/MAL/HDP/2911 AXCEL LORATADINE

NDA/MAL/HDP/3026

NDA/MAL/HDP/6249

NDA/MAL/HDP/6774

NDA/MAL/HDP/6777 AXCEL FUSIDIC ACID

KOTRAPHARMA (M) SDN.BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL DETROMETHORPHAN-15 SYRUP

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL METRONIDAZOLE -200 TABLETS

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL FLEMIN EXPECTORANT

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 170: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6778 AXCEL IBUPROFEN

NDA/MAL/HDP/5475 VAXCEL CEFTAZIDIME

NDA/MAL/HDP/8494 VAXCEL CEFOBACTAM

NDA/MAL/HDP/0567 KOTRA PHARMA SDN BDN

NDA/MAL/HDP/1224 VAXCEL CEFTRIAXONE

NDA/MAL/HDP/0669 AXEL FUNGICORT CREAM

NDA/MAL/HDP/0675

NDA/MAL/HDP/2186

NDA/MAL/HDP/5333 IBUFEN

NDA/MAL/HDP/2091 CAMSTON

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

VAXCEL CEFTRIAZONE 500MG

KOTRAPHARMA (M) SDN.BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

KOTRA PHARMA (M) SDN,BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL METRONIDAZOLE 400

KOTRA PHARMA (M) SDN BHD

UNITED HEALTHCARE DISTRIBUTORS LTD

AXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUP

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

Page 171: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0626 KPI INDUSTRIES(1996) LTED CARDIPAC-10

NDA/MAL/HDP/2890 KPI INDUSTRIES(1996) LTED BETASOL N

NDA/MAL/HDP/2896 KPI INDUSTRIES(1996) LTED MCG CREAM

NDA/MAL/HDP/0343

NDA/MAL/HDP/0340 SONADAY

NDA/MAL/HDP/0054 FUNGOAL

NDA/MAL/HDP/0703 DICLODAY GEL

NDA/MAL/HDP/0287 POWER HEAT

NDA/MAL/HDP/3179 SULPHUR OINTMENT

NDA/MAL/HDP/0335

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

WHITFIELD'S OINTMENT B.P

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

NEOMYCIN SULPHATE CREAM USP

Page 172: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6651 CYCLOVEER

NDA/MAL/HDP/8236 KWALITY AFRO-ASIA LTD.. KWALITY AFRO ASIA LTD HYDROGEN PEROXIDE

NDA/MAL/HDP/8172 ACINO PHARMA AG COAMOX-ACINO 875

NDA/MAL/HDP/0549 HIDRASEC

NDA/MAL/HDP/0552 HIDRASEC INFANTS

NDA/MAL/HDP/0556 HIDRASEC CHILDREN

NDA/MAL/HDP/3833

NDA/MAL/HDP/1763 LABORATORY&ALLIED LTD ASPIRIN TABLETS BP

NDA/MAL/HDP/1801 LABESTEN PESSARIES

NDA/MAL/HDP/2191 KLOXY

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOODMAN INTERNATIONAL LTD

ABOTT LABORATORIES S.A (PTY) LTD

LABOREX UGANDA LIMITED

ABOTT LABORATORIES S.A (PTY) LIMITED

LABOREX UGANDA LIMITED

ABOTT LABORATORIES S.A (PTY) LTD

LABOREX UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABSTATIN VAGINAL TABLETS

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

Page 173: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2528 LABESTEN

NDA/MAL/HDP/3116 KLOXY

NDA/MAL/HDP/1497 LAEOVATE CREAM

NDA/MAL/HDP/0290 NATOA

NDA/MAL/HDP/3723 LACILLIN

NDA/MAL/HDP/3782 LAE-PEN V

NDA/MAL/HDP/3970 LECOTRIM

NDA/MAL/HDP/5199 HYCORUM OINTMENT

NDA/MAL/HDP/5295 LABORATORY&ALLIED LTD DOXY

NDA/MAL/HDP/1783 LAEOVATE OINTMENT

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

Page 174: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1848 LABORATORY&ALLIED LTD PARATAL

NDA/MAL/HDP/3200 LETRAX

NDA/MAL/HDP/3284 LABORATORY&ALLIED LTD CHALEATE

NDA/MAL/HDP/3710 LACILLIN

NDA/MAL/HDP/8411 RHEUMAC GEL

NDA/MAL/HDP/0497 LABORATORY&ALLIED LTD

NDA/MAL/HDP/4815 FERROLIC-LF

NDA/MAL/HDP/4818 FERROUS SULPHATE

NDA/MAL/HDP/4926 LABORATORY&ALLIED LTD FOLIC ACID

NDA/MAL/HDP/5341 LABORATORY&ALLIED LTD HYODOPA

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

KEMOXYL DRY SUSPENSION

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

Page 175: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1708 DENTAMOL

NDA/MAL/HDP/2197 LABORATORY&ALLIED LTD WHITFIELD'S OINTMENT

NDA/MAL/HDP/6340 LABORATORY & ALLIED LTD AXYLIN CAPSULES

NDA/MAL/HDP/6671 LABORATORY & ALLIED LTD NOPEN

NDA/MAL/HDP/8092 LABORATORY & ALLIED LTD KEMOXYL 250MG

NDA/MAL/HDP/4627 HYCORUM CREAM

NDA/MAL/HDP/5052 GLAMIDE TABLETS

NDA/MAL/HDP/5436 CEFICAD 1000

NDA/MAL/HDP/1411 CIPIUM

NDA/MAL/HDP/4093 LEBEN LABORATORIES LTD BECLOMIN OINTMENT

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

LABORATORY AND ALLIED LTD

HARLEYS UGANDA LIMITED

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

CADILA PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

ANDYCO PHARMACY (UGANDA) LTD

Page 176: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4095 IBUT-200

NDA/MAL/HDP/4920 LEBEN LABORATORIES LTD FOLIBEN

NDA/MAL/HDP/5109 LEBASMA ORAL SOLUTION

NDA/MAL/HDP/5320 INDOL

NDA/MAL/HDP/2078 ALCLOX SYRUP

NDA/MAL/HDP/0482 AZILEB-500

NDA/MAL/HDP/0489 CEBAY-200 DT

NDA/MAL/HDP/1406 CEBAY DRY SYRUP

NDA/MAL/HDP/0486 ADIFLAM-SR

NDA/MAL/HDP/0394 DOXYLEB

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

Page 177: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0877 LEBEN LABORATORIES LTD

NDA/MAL/HDP/1338 GRISEBEN 500

NDA/MAL/HDP/0456 METROLEB

NDA/MAL/HDP/1426 METROLEB

NDA/MAL/HDP/0434 PROHIBIN

NDA/MAL/HDP/0874 LEBASMA-4

NDA/MAL/HDP/3784 CIPIUM

NDA/MAL/HDP/4086 KELVIN SUSPENSION

NDA/MAL/HDP/2097 ALCLOX

NDA/MAL/HDP/2218 LEBEN LABORATORIES LTD

ANDYCO PHARMACY (UGANDA) LTD

ANTAGIT DS GEL MINT FLAVOUR

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

ANDYCO PHARMACY (UGANDA) LTD

CHLORPROMAZINE TABLETS

Page 178: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2675 LIBITUS PLUS SYRUP

NDA/MAL/HDP/3002 LEBEN LABORATORIES LTD KELVIN

NDA/MAL/HDP/3095 AMPHEN SUSPENSION

NDA/MAL/HDP/3104

NDA/MAL/HDP/3232 L-TRIM

NDA/MAL/HDP/3535 ADIFLAM-50

NDA/MAL/HDP/6325 PZQ TABLET

NDA/MAL/HDP/8329 ARTEFLO - 40

NDA/MAL/HDP/0531 LEBEN LABORATORIES LTD ENDERM-GM

NDA/MAL/HDP/1679 CIPROLEB

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NYSTALEB ORAL SUSPENSION

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD.

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD., INDIA

ANDYCO PHARMACY (UGANDA) LTD

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT. LTD

ANDYCO PHARMACY (UGANDA) LTD

Page 179: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1846

NDA/MAL/HDP/1847 MOXILEB-250 CAPSULE

NDA/MAL/HDP/1425 L-TRIM

NDA/MAL/HDP/3079 ACINO PHARMA AG CO-AMOX ACINO 457

NDA/MAL/HDP/3080 ACINO PHARMA AG CO-AMOX ACINO 156.25

NDA/MAL/HDP/4409 SANDOZ GMBH . ROBESTAR

NDA/MAL/HDP/4298 COLESTOP

NDA/MAL/HDP/6720 COLESTOP

NDA/MAL/HDP/7728 LINEX

NDA/MAL/HDP/7632 SANDOZ GMBH, KUNDL

LEBEN LABORATORIES PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

ANTAGIT DS GEL ORANGE FLAVOUR

LEBEN LABORATORIES PVT. LTD., INDIA

ANDYCO PHARMACY (UGANDA) LTD

LEBEN LABORATORIES PVT.LTD

ANDYCO PHARMACY (UGANDA) LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

SURGIPHARM (U) LIMITED

SANDOZ GMBH, KENYA C/O NORVATIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ GMBH, KENYA C/O NORVATIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

NORVATIS PHARMA SERVICES INC.

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

BISOPROLOL 2.5 MG FILM-COATED TABLETS

Page 180: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7634 SANDOZ GMBH, KUNDL BISOPROLOL

NDA/MAL/HDP/8658 SANDOZ GMBH, KUNDL METFORMIN 1000MG

NDA/MAL/HDP/8659 SANDOZ GMBH, KUNDL METFORMIN 500MG

NDA/MAL/HDP/7635 SANDOZ GMBH, KUNDL

NDA/MAL/HDP/8483 SANDOZ KENYA LTD

NDA/MAL/HDP/6053 GLIMEPIRID SANDOZ

NDA/MAL/HDP/6054 GLIMEPIRID SANDOZ

NDA/MAL/HDP/8158 GLIMEPIRID SANDOZ

NDA/MAL/HDP/4343 EUVAX B (PAEDIATRIC)

NDA/MAL/HDP/8230 LIFEPHARM FZE AIVEEN (U) LIMITED PANALIFE

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

BISOPROLOL 10MG FILM-COATED TABLETS

SURGIPHARM (U) LIMITED

GLIMEPIRID SANDOZ® 2MG TABLETS

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

PASTEUR MERIEUX CONNANGHT

LABOREX UGANDA LIMITED

Page 181: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7139 LIFEPHARM FZE AIVEEN (U) LIMITED COLDIFED SYRUP

NDA/MAL/HDP/4602 ELI-LILLY (SUISSE) SA HUMALOG MIX 50

NDA/MAL/HDP/5002 ELI-LILLY EXPORT SA HUMALOG MIX 25

NDA/MAL/HDP/3440 ELI-LILLY EXPORT SA HUMALOG

NDA/MAL/HDP/7406 ARENA

NDA/MAL/HDP/8481

NDA/MAL/HDP/1749 VITAMIN B COMPLEX

NDA/MAL/HDP/8225 ARTELIN 60

NDA/MAL/HDP/8424 HAEMRICH

NDA/MAL/HDP/0721 ARH-A

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

LINCOLN PARENTERAL LIMITED

METRO PHARMACEUTICALS LIMITED

PARACETAMOL BP INJECTION

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PARENTERAL LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PARENTERAL LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

Page 182: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0540 HYDRICORT

NDA/MAL/HDP/1556 DOMI UP

NDA/MAL/HDP/2821 DIOLIN-M

NDA/MAL/HDP/0705 ACICLOVIR

NDA/MAL/HDP/4588 FLUCAN 200

NDA/MAL/HDP/4592 PENTALINK 40

NDA/MAL/HDP/4595 VAST-20

NDA/MAL/HDP/5292 DOMI 10

NDA/MAL/HDP/1682 TOFLOX-200

NDA/MAL/HDP/3087

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

SULPHATRIM TABLETS B.P. 480

Page 183: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3225 DIFLAME

NDA/MAL/HDP/3231 FLUCOMOL

NDA/MAL/HDP/3237 KONAZOL CREAM

NDA/MAL/HDP/3666 STROM 50

NDA/MAL/HDP/6776 M-FORLIN 500

NDA/MAL/HDP/1128 BTC KIT

NDA/MAL/HDP/0716 GLYMET-1

NDA/MAL/HDP/0718 GLYMET-2

NDA/MAL/HDP/0836 CALBONE-500

NDA/MAL/HDP/0850 LCT KIT

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

Page 184: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0845 OLEVO-500

NDA/MAL/HDP/0269 VOMISTAT-8

NDA/MAL/HDP/0477 VOMISTAT-4

NDA/MAL/HDP/0842 SAC

NDA/MAL/HDP/0475 TINI-500

NDA/MAL/HDP/3275 MEFLIN-500

NDA/MAL/HDP/0834 VOMI-6

NDA/MAL/HDP/1130 KLARO-500

NDA/MAL/HDP/1143 LINCOLN P'CALS LTD LOSA-H

NDA/MAL/HDP/1020 PA-12

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

Page 185: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1687 ALLDOX

NDA/MAL/HDP/2504 RESTOCIN

NDA/MAL/HDP/2835 SOLUDINE-M

NDA/MAL/HDP/3297 NEPIN-SR-20

NDA/MAL/HDP/3321 DERMOLIN-GM

NDA/MAL/HDP/3341 AZILIN-250

NDA/MAL/HDP/3352 OMLINK-20

NDA/MAL/HDP/3369 AZILIN-500

NDA/MAL/HDP/0222 AVIR-200

NDA/MAL/HDP/0217 PALETHER

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

Page 186: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0252 VAST-40

NDA/MAL/HDP/0528 CLARY 500

NDA/MAL/HDP/0641 GYNAZOLE

NDA/MAL/HDP/0250 DIKON

NDA/MAL/HDP/0225 DIKON PLUS

NDA/MAL/HDP/0610 PYLOR KIT

NDA/MAL/HDP/0532 SARTAN-50

NDA/MAL/HDP/0617 SILVEX

NDA/MAL/HDP/1559 DOLOMOL

NDA/MAL/HDP/4273 SOLUDINE 10%

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

Page 187: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4381 DICLOFENAC SODIUM

NDA/MAL/HDP/4402 CLOTRILIN

NDA/MAL/HDP/1684 IBUN-200

NDA/MAL/HDP/1686 QUININE SULPHATE

NDA/MAL/HDP/1975 BET-CODERM N

NDA/MAL/HDP/0623 GELCID

NDA/MAL/HDP/1582 CEEPRO-500

NDA/MAL/HDP/0995 FLUCOMOL

NDA/MAL/HDP/4004 ANTHEL

NDA/MAL/HDP/4866 FLUCAN

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

LINCON PHARMCUETICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

Page 188: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5100 L-GENTA

NDA/MAL/HDP/3241 CLOTRILIN

NDA/MAL/HDP/6808 GLYGEN-500

NDA/MAL/HDP/8192 L-KELFIN

NDA/MAL/HDP/8475 OROCAN

NDA/MAL/HDP/4391 MOBYLE-A

NDA/MAL/HDP/6267 BENLE CONSULT LIMITED TRAMADOL DENK 50

NDA/MAL/HDP/8255 MEDICATRIX (U) LTD PROSTAN ED

NDA/MAL/HDP/8470 LUPIN LIMITED AIVEEN (U) LIMITED IXIME 400

NDA/MAL/HDP/8471 LUPIN LIMITED AIVEEN (U) LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

ABACUS PARENTERAL DRUGS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

LINCOLN PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

DENK PHARMA GMBH & CO KG

KORLYNS THERAPEUTICS LTD

IXIME FOR ORAL SUSPENSION

Page 189: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3020 M.J BIOPHARM PVT LTD TATA UGANDA LIMITED BIOSULIN N

NDA/MAL/HDP/3184 M.J BOPHARM PUT LTD TATA UGANDA LIMITED MONAN

NDA/MAL/HDP/1998 M.J.BIOPHARM PVT LTD TATA UGANDA LIMITED TEICO 500

NDA/MAL/HDP/3022 M.J BIOPHARM PVT LTD TATA UGANDA LIMITED BIOSULIN L

NDA/MAL/HDP/3030 MJ BIOPHARM PVT LTD TATA UGANDA LIMITED BIOSULIN R

NDA/MAL/HDP/3143 MJ BIOPHARM PVT LTD TATA UGANDA LIMITED OMIPIX 20

NDA/MAL/HDP/3153 M.J BIOPHARM PVT LTD TATA UGANDA LIMITED CEFUROXIME-MJ

NDA/MAL/HDP/3158 MJ BIOPHARM PVT LTD TATA UGANDA LIMITED GLIBEX-5

NDA/MAL/HDP/3167 MJ BIOPHARM PVT LTD TATA UGANDA LIMITED MONAN-0.5G

NDA/MAL/HDP/3180 MJ BIOPHARM PVT LTD TATA UGANDA LIMITED LOFIN 500

Page 190: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3162 M.J BIOPHARM PST LTD TATA UGANDA LIMITED KLAROL

NDA/MAL/HDP/4728 M.J.BIOPHARM PVT LTD TATA UGANDA LIMITED ADRENALINE

NDA/MAL/HDP/2687 M.J BIOPHARM PVT LTD TATA UGANDA LIMITED TEICO 1000

NDA/MAL/HDP/3453 MJ BIOPHARM PVT LTD TATA UGANDA LIMITED AMINOPHYLLINE

NDA/MAL/HDP/6744 M.J.BIOPHARM PVT LTD TATA UGANDA LIMITED

NDA/MAL/HDP/0047 LAMIHOPE ET

NDA/MAL/HDP/1784 AZICURE-500

NDA/MAL/HDP/2902 MEGALIS-20

NDA/MAL/HDP/4362 LEVOMAC 750

NDA/MAL/HDP/6134 ZAMADOL P

CEFTRIAXONE FOR INJECTION

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICAL LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

Page 191: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6439 LIZOMAC 600

NDA/MAL/HDP/6465 NEUROGAB 75

NDA/MAL/HDP/6529

NDA/MAL/HDP/6270 FEBUMAC 80

NDA/MAL/HDP/7424

NDA/MAL/HDP/0852 KAPOCIN-1G

NDA/MAL/HDP/0843 COXERIN

NDA/MAL/HDP/0381

NDA/MAL/HDP/0841 ETHOMID

NDA/MAL/HDP/0856 KANAMAC-1000

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

PRAZIQUANTEL TABLETS 600 MG

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

ZINC SULFATE TABLETS USP 20MG

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICAL LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

EFAVIRENZ/EMTRICITABINE/TENOFOVIR

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICAL LTD

NORVIK ENTERPRISES LIMITED

Page 192: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0205

NDA/MAL/HDP/3826 KETOMAC

NDA/MAL/HDP/5277 EFAVIRENZ

NDA/MAL/HDP/1677 ZIDOVUDINE

NDA/MAL/HDP/2116 AMLOVAS-10

NDA/MAL/HDP/2885 FORECOX-TRAC

NDA/MAL/HDP/2891 TORVAST 20

NDA/MAL/HDP/2898 TORVAST 10

NDA/MAL/HDP/2906

NDA/MAL/HDP/3676 COTRIMOXAZOLE

MACLEODS PHARMACEUTICALS LTDS LTD

NORVIK ENTERPRISES LIMITED

TENOFOVIR DISOPROXIL FUMARATE

MACLEODS PHARMACEUTICAL LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

RIFAMPICIN/ISONIAZID/ETHAMBUTOL

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

Page 193: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8116

NDA/MAL/HDP/8118 LOPINAVIR + RITONAVIR

NDA/MAL/HDP/1891 LEVOMAC 500

NDA/MAL/HDP/1892 LEVOMAC 250

NDA/MAL/HDP/2314 RABEMAC-20

NDA/MAL/HDP/1713 LUMITER

NDA/MAL/HDP/5418

NDA/MAL/HDP/7726 LOPINAVIR + RITONAVIR

NDA/MAL/HDP/8202 ISONIAZID

NDA/MAL/HDP/8340 MONTEMAC 5

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICAL LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

PAEDIATRIC CO-TRIMOXAZOLE

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LTD -MBARARA

Page 194: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0251

NDA/MAL/HDP/1325

NDA/MAL/HDP/6341 ROSUMAC 20

NDA/MAL/HDP/8394

NDA/MAL/HDP/8395

NDA/MAL/HDP/1234 BISACODYL TABLETS BP

NDA/MAL/HDP/4371 NEVIHOPE 200

NDA/MAL/HDP/6760

NDA/MAL/HDP/8115 LAMIVUDINE

NDA/MAL/HDP/0846 MOXIMAC

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

LAMIVUDINE + ZIDOVUDINE

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

RIFAMPICIN 75 MG ISONIAZID 50 MG AND PYRAZINAMIDE 150 MG DISPERSIBLE TABLETS

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

RIFAMPICIN 75 MG ISONIAZID 50 MG DISPERSABLE TABLETS

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

RIFAMPACIN/ ISONIAZID DISPERSIBLE TABLET

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

Page 195: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0943

NDA/MAL/HDP/0849 MONOPAS-4G

NDA/MAL/HDP/0848 MACROZIDE 500

NDA/MAL/HDP/3692 COTRIM 120

NDA/MAL/HDP/0207

NDA/MAL/HDP/1949 TRENAXA 500

NDA/MAL/HDP/1951 CLOPI 75

NDA/MAL/HDP/2058 QUININE SULPHATE

NDA/MAL/HDP/1453 ZEE PHARMACEUTICALS LTD ZESOZ-40

NDA/MAL/HDP/6974 TATA UGANDA LIMITED VOMIKIND-MD 4

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

STREPTOMYCIN INJECTION BP

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICAL LTD

NORVIK ENTERPRISES LIMITED

LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

MACLEODS PHARMACEUTICALS LTDS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

MACLEODS PHARMACEUTICALS LTD

NORVIK ENTERPRISES LIMITED

ZEE PHARMACEUTICALS LIMITED

MANKIND PHARMA LIMITED

Page 196: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6520 TATA UGANDA LIMITED VOMIKIND-MD 8

NDA/MAL/HDP/6610 TATA UGANDA LIMITED VOMIKIND

NDA/MAL/HDP/6948 TATA UGANDA LIMITED D3 MUST 60 K

NDA/MAL/HDP/6970 TATA UGANDA LIMITED VOMIKIND ORAL SOLUTION

NDA/MAL/HDP/0031 MANKIND PHARM LTD TATA UGANDA LIMITED CEFTATIME-SB 1.5

NDA/MAL/HDP/5462 SANOFI AVENTIS

NDA/MAL/HDP/5461 SANOFI AVENTIS

NDA/MAL/HDP/5463 SANOFI AVENTIS

NDA/MAL/HDP/0106 MSN LABORATORIES LTD SAFELEVO

NDA/MAL/HDP/6074 CARDILOL CS

MANKIND PHARMA LIMITED

MANKIND PHARMA LIMITED

MANKIND PHARMA LIMITED

MANKIND PHARMA LIMITED

LABOREX UGANDA LIMITED

ARTESUNATE AMODIAQUINE WINTHROP

LABOREX UGANDA LIMITED

ARTESUNATE AMODIAQUINE

LABOREX UGANDA LIMITED

ARTESUNATE AMODIAQUINE WINTHROP

GOOD DAY PHARMACY LIMITED

MARCYRL PHARMACEUTICAL INDUSTRIES

SHREEJI PHARMACEUTICALS LIMITED

Page 197: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6143 CONTRACTUBEX

NDA/MAL/HDP/8602

NDA/MAL/HDP/8603

NDA/MAL/HDP/8604 PYODINE

NDA/MAL/HDP/8605 HYDROGEN PEROXIDE

NDA/MAL/HDP/8606

NDA/MAL/HDP/8611 SURGICAL SPIRIT

NDA/MAL/HDP/8615 CALAMINE LOTION

NDA/MAL/HDP/8617 MAVID'S KEVLON

NDA/MAL/HDP/3431 NAZOL-200

MARCYRL PHARMACEUTICAL INDUSTRIES

SHREEJI PHARMACEUTICALS LIMITED

MAVID PHARMACEUTICALS LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

KOFLIN COUGH FLU LINCTUS

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAGNESIUM TRISILICATE SUSPENSION

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

DIPHEX COUGH EXPECTORANT

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

MAVID PHARMACEUTICAL INDUSTRIES LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 198: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3533 ABACUS PHARMA (A) LTD. LEVOZIN

NDA/MAL/HDP/3604 ABACUS PHARMA LTD AC-FENAC

NDA/MAL/HDP/6615 PINPAC 50

NDA/MAL/HDP/3980 AB-TONE TONIC

NDA/MAL/HDP/3983 EXTRADOL

NDA/MAL/HDP/5378 ABACUS PHARMA (A) LTD. X-VITA

NDA/MAL/HDP/3960 IBUPAR

NDA/MAL/HDP/4712 ABACUS PHARMA LTD MEFINAL-500

NDA/MAL/HDP/6197 NYSTATIN

NDA/MAL/HDP/6189 WORMEE-4

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

UNEED GLOBAL GROUP LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 199: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1503 SEDIPROCT CREAM

NDA/MAL/HDP/3881 MOXACIL

NDA/MAL/HDP/4748

NDA/MAL/HDP/4863 MICONAZ ORAL GEL

NDA/MAL/HDP/4865 MICONAZ CREAM

NDA/MAL/HDP/2136 SEDIPROCT SUPOSITORY

NDA/MAL/HDP/3300

NDA/MAL/HDP/3709 NIGHT & DAY -N

NDA/MAL/HDP/0052 DISPERCAM

NDA/MAL/HDP/2654 BEBE VIT

MEDICAL UNION PHARMACUITICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

ACICONE-S CHEWABLE TABLET

MEDICAL UNION PHARMACUITICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACUITICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MUCOSOL PEDIATRIC SYRUP

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

Page 200: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5410 UNICTAM 1500

NDA/MAL/HDP/3490 LAXOLAC SYRUP

NDA/MAL/HDP/0210 HEPATICUM

NDA/MAL/HDP/0212 HEPATICUM

NDA/MAL/HDP/6126 DERMOTRACIN

NDA/MAL/HDP/2850 DISPERCAM

NDA/MAL/HDP/6840 LIPINORM

NDA/MAL/HDP/5035 ABACUS PHARMA LTD MEBENDAZOLE

NDA/MAL/HDP/3669 ABACUS PHARMA (A) LTD. CO-TRIMOXAZOLE

NDA/MAL/HDP/3853 MISSION PHARMA A/S

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

MEDICAL UNION PHARMACEUTICALS

KARURI PHARMACEUTICALS LTD.

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

JOINT MEDICAL STORE (UPMB - UCMB)

ZINC SULPHATE TABLET USP

Page 201: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4338 MISSION PHARMA ALBENDAZOLE

NDA/MAL/HDP/4786 MISSION PHARMA A/S COTRIMOXAZOLE 960MG

NDA/MAL/HDP/5268 MISSION PHARMA A/S INDIA

NDA/MAL/HDP/5309 MISSION PHARMA A/S INDIA DOXYCYCLINE CAPSULES BP

NDA/MAL/HDP/1771 MISSION PHARMA A/S

NDA/MAL/HDP/2767 MISSION PHARMA A/S INDIA

NDA/MAL/HDP/2784 MISSION PHARMA A/S

NDA/MAL/HDP/2887 MISSION PHARMA A/S QUININE SULPHATE

NDA/MAL/HDP/3517 ABACUS PHARMA (A) LTD. TOTO ZINC

NDA/MAL/HDP/8109 ABACUS PHARMA LTD IRON FOLATE

JOINT MEDICAL STORE (UPMB - UCMB)

JOINT MEDICAL STORE (UPMB - UCMB)

JOINT MEDICAL STORE (UPMB - UCMB)

ERYTHROMYCIN STEARATE TABLETS

JOINT MEDICAL STORE (UPMB - UCMB)

JOINT MEDICAL STORE (UPMB - UCMB)

ORAL REHYDRATION SALTS BP

JOINT MEDICAL STORE (UPMB - UCMB)

PHENOXYMETHYLPENICILLIN TABLETS BP

JOINT MEDICAL STORE (UPMB - UCMB)

AMOXICILLIN ORAL SUSPENSION

JOINT MEDICAL STORE (UPMB - UCMB)

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 202: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8200 ORS ORANGE

NDA/MAL/HDP/1531 CIPLA LTD NOVATAX

NDA/MAL/HDP/1351 ATORIN

NDA/MAL/HDP/1353 KITPYLO - C

NDA/MAL/HDP/2423 ATORIN

NDA/MAL/HDP/8198 ZYMEX DROPS

NDA/MAL/HDP/8199 ZYMEX SYRUP

NDA/MAL/HDP/3737 ECOFLOX 500 TABLETS

NDA/MAL/HDP/2522 PANTAZ TABLETS

NDA/MAL/HDP/2524 PRIMODIL-5

MEDIPHARM INDUSTRIES LTD

MEDIPHARM SALES LIMITED

QUALITY CHEMICALS LTD - HUMAN

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

Page 203: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2998 FITIN-5

NDA/MAL/HDP/2997 ACENAC TABLETS

NDA/MAL/HDP/6986 REPRAZ 20 TABLETS

NDA/MAL/HDP/6987 PORAZ CAPSULES

NDA/MAL/HDP/3725 NEW TUXIRIL

NDA/MAL/HDP/3729 MEDLEY PHARMACEUTICALS DECIFEN-SR

NDA/MAL/HDP/3809 COLDRID DAY & NIGHT

NDA/MAL/HDP/2004 R.B.TONE

NDA/MAL/HDP/2521 MOTINORM

NDA/MAL/HDP/6985 COLDRID SYRUP

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

Page 204: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8110 R.B.TONE SYRUP

NDA/MAL/HDP/2595 MEDOCHEMIE LTD ZEPILEN

NDA/MAL/HDP/2601 MEDOCHEMIE LTD AXETINE 750MG

NDA/MAL/HDP/6574 MEDOCHEMIE LTD ARCHIFAR

NDA/MAL/HDP/0233 MEDOCHEMIE LTD CEFIMED 400

NDA/MAL/HDP/1736 MEDOCHEMIE LTD KLERIMED

NDA/MAL/HDP/1743 MEDOCHEMIE LTD DAPRIL

NDA/MAL/HDP/2642 MEDOCHEMIE LTD MEDOXANUM

NDA/MAL/HDP/8484 MEDOCHEMIE LTD AVERNOL

NDA/MAL/HDP/4990 IDA FOUNDATION KIMSY MEDS LTD COTRIMOXAZOLE

MEDLEY PHARMACEUTICALS LTD

MEDVIN PHARMA LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

Page 205: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4990 IDA FOUNDATION KIMSY MEDS LTD COTRIMOXAZOLE

NDA/MAL/HDP/0529 TATA UGANDA LIMITED MOXIKIND-CV

NDA/MAL/HDP/3173 MEDOCILLIN 250

NDA/MAL/HDP/0191 CLEDOMOX 228.5

NDA/MAL/HDP/0193 CLEDOMOX 625

NDA/MAL/HDP/0534 TATA UGANDA LIMITED MOXIKIND-CV 375

NDA/MAL/HDP/0536 TATA UGANDA LIMITED MOXIKIND-CV 625

NDA/MAL/HDP/1231 MEDOMOX 125

NDA/MAL/HDP/1232 MEDOCILLIN 125

NDA/MAL/HDP/1230 LOXAMP

MANKIND PHARMA LIMITED

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MANKIND PHARMA LIMITED

MANKIND PHARMA LIMITED

NORVIK ENTERPRISES LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

Page 206: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4670 MEDOMOX 500

NDA/MAL/HDP/2787

NDA/MAL/HDP/3507 MEDOMOX 250

NDA/MAL/HDP/8326 MEDOMOX 250 DT

NDA/MAL/HDP/6208 WOCKHARDT LTD WOCKLAV

NDA/MAL/HDP/1326 IDA KIMSY MEDS LTD CO-TRIMOXAZOLE 480MG

NDA/MAL/HDP/3792 MEDREICH PLC FLEMING 228.5

NDA/MAL/HDP/0148 KIMSY MEDS LTD SYNCLAV 1000

NDA/MAL/HDP/0150 KIMSY MEDS LTD SYNCLAV 228

NDA/MAL/HDP/2102 MEDREICH PLC FLEMING 625

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

AMOXICILLIN TABLETS FOR ORAL SUSPENSION

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

MEDOPHARM PRIVATE LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

STAR PHARMACEUTICALS LTD

LABOREX UGANDA LIMITED

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

LABOREX UGANDA LIMITED

Page 207: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2103 MEDREICH PLC FLEMING 1000 TAB

NDA/MAL/HDP/2105 MEDREICH PLC FLEMING 156MG/5ML

NDA/MAL/HDP/0149 KIMSY MEDS LTD SYNCLAV 625

NDA/MAL/HDP/0146 KIMSY MEDS LTD CEF2 250

NDA/MAL/HDP/0147 KIMSY MEDS LTD CEF 2 500

NDA/MAL/HDP/4862 ERIS LTD FLOXAPEN SYRUP

NDA/MAL/HDP/0527 KIMSY MEDS LTD XAFEN-120

NDA/MAL/HDP/0530 KIMSY MEDS LTD XAFEN-180

NDA/MAL/HDP/0524 KIMSY MEDS LTD XAFEN-60

NDA/MAL/HDP/3155 MEDREICH PLC BIOFERON

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

LABOREX UGANDA LIMITED

Page 208: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3165 MEDREICH PLC MUCODIL EXPECTORANT

NDA/MAL/HDP/4018 MEDREICH PLC ZEBEN

NDA/MAL/HDP/3961 MEDREICH PLC BIOFERON

NDA/MAL/HDP/3438 MEDREICH PLC PROXACIN

NDA/MAL/HDP/8503 MEDREICH PLC NORZOL

NDA/MAL/HDP/1522 ERIS LTD PENAMOX

NDA/MAL/HDP/3981 GLAXO SMITH KLINE LTD ERIS LTD PENAMOX

NDA/MAL/HDP/1807 ERIS LTD

NDA/MAL/HDP/2566 MEDREICH PLC ZEBEN

NDA/MAL/HDP/3033 ERIS LTD PENAMOX

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

AMPICLOX NEONATAL DROPS

LABOREX UGANDA LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 209: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3106 PENAMOX

NDA/MAL/HDP/3615 ERIS LTD AMPICLOX

NDA/MAL/HDP/8100 ERIS LTD AMPICLOX

NDA/MAL/HDP/8502 MEDREICH PLC FLEMING

NDA/MAL/HDP/3828 MEDREICH PLC PARAFLAM

NDA/MAL/HDP/2276 MEDREICH PLC FUNGRAL

NDA/MAL/HDP/5023 ERIS LTD COTREICH

NDA/MAL/HDP/2285 MEDREICH PLC BRUMED

NDA/MAL/HDP/5039 GILOBA

NDA/MAL/HDP/2957 MEDITROL

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

LABOREX UGANDA LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

LABOREX UGANDA LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

MEDIPHARM SALES (E.A) LTD

ABACUS PHARMA (AFRICA) LIMITED

Page 210: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3497 LIVOLIN FORTE

NDA/MAL/HDP/7004 DUOCETZ

NDA/MAL/HDP/4718 ACNOTIN 20

NDA/MAL/HDP/4719 ACNOTIN 10

NDA/MAL/HDP/4953 NAT-B

NDA/MAL/HDP/2401 ENAT

NDA/MAL/HDP/2519 VITA CAP

NDA/MAL/HDP/5128 MEDIPHARM SALES LTD GOFEN 400 CLEARCAP

NDA/MAL/HDP/3319 FERROTONE CAPSULES

NDA/MAL/HDP/2451 ACINO PHARMA AG OLFEN 75 SR

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

MEGA LIFESCIENCES PUBLIC COMPANY LTD

ABACUS PHARMA (AFRICA) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

SURGIPHARM (U) LIMITED

GOODMAN INTERNATIONAL LTD

Page 211: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2455 ACINO PHARMA AG

NDA/MAL/HDP/2579 ACINO PHARMA AG

NDA/MAL/HDP/0499 NVS KENYA LTD BANEOCIN OINTMENT

NDA/MAL/HDP/0830 MERCK (PTY) LTD EUTHYROX 25 MCG

NDA/MAL/HDP/0254 MERCK (PTY) LTD CONCOR 5

NDA/MAL/HDP/1436 MERCK (PTY) LTD CONCOR 10

NDA/MAL/HDP/7353 MERCK (PTY) LTD GLUCOPHAGE XR 500MG

NDA/MAL/HDP/8655 MERCK (PTY) LTD GLUCOPHAGE XR 1000MG

NDA/MAL/HDP/0832 MERCK (PTY) LTD EUTHYROX 100MCG

NDA/MAL/HDP/2199 MERCK (PTY) LTD EUTHYROX 50MCG

GOODMAN INTERNATIONAL LTD

ARTEQUIN 600/750 LACTAB

GOODMAN INTERNATIONAL LTD

ARTEQUIN 300/375 LACTAB

SURGIPHARM (U) LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 212: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2303 ZIAK 5/6.25

NDA/MAL/HDP/2304 ZIAK 10/6.25

NDA/MAL/HDP/2305 ZIAK 2.5/6.25

NDA/MAL/HDP/5103 MERCK (PTY) LTD GLUCOPHAGE 1000MG

NDA/MAL/HDP/0882 MERCK (PTY) LTD

NDA/MAL/HDP/0883 MERCK (PTY) LTD

NDA/MAL/HDP/8467 MERCK (PTY) LTD GLUCOPHAGE XR 750MG

NDA/MAL/HDP/5102 MERCK (PTY) LTD GLUCOPHAGE 500MG

NDA/MAL/HDP/0060 MERCK (PTY) LTD

NDA/MAL/HDP/0064 MERCK (PTY) LTD

MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

MERCK PHARMACEUTICAL MANUFACTURING (PYT) LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

GLUCOVANCE 500MG/2.5MG

UNITED HEALTHCARE DISTRIBUTORS LTD

GLUCOVANCE 500MG/5MG

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

GONAL-F PEN 300 IU/0,5 ML (22 µG/0,5 ML)

UNITED HEALTHCARE DISTRIBUTORS LTD

GONAL-F PEN 450 IU/ IE 0,75 ML (33 µG)

Page 213: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4973 MERCK (PTY) LTD PERGOVERIS

NDA/MAL/HDP/5133 MERCK (PTY) LTD

NDA/MAL/HDP/4312 MERCK (PTY) LTD GONAL-F

NDA/MAL/HDP/1179 MERCK (PTY) LTD OVITRELLE

NDA/MAL/HDP/1500 MERCK SHARP & DOHME BV ATRIPLA

NDA/MAL/HDP/4777 MERCK SHARP & DOHME BV CRIXIVAN

NDA/MAL/HDP/4350 ACINO PHARMA AG OLFEN-75

NDA/MAL/HDP/5414 ACINO PHARMA AG XYLO-ACINO 0.1%

NDA/MAL/HDP/2357 ACINO PHARMA AG TRABILIN- 50 CAPSULES

NDA/MAL/HDP/2562 ACINO PHARMA AG TRABILIN-100

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

GONAL-F PEN 900IU/1.5ML(66MCG/1.5ML)

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

Page 214: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3032 ACINO PHARMA AG XYLO-ACINO 0.05%

NDA/MAL/HDP/3400 ACINO PHARMA AG OLFEN GEL

NDA/MAL/HDP/6437 PILORECT

NDA/MAL/HDP/6397 INDOSUPP 100

NDA/MAL/HDP/6400 FENSUPP-100

NDA/MAL/HDP/8238 METROSUPP 500

NDA/MAL/HDP/6401

NDA/MAL/HDP/4694 ROTATEQ

NDA/MAL/HDP/1675 MERCK SHARP & DOHME BV GARDASIL

NDA/MAL/HDP/7928 SHURIK LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

MERIDIAN ENTERPRISES PRIVATE LIMITED.

ABACUS PHARMA (AFRICA) LIMITED

MERIDIAN ENTERPRISES PRIVATE LIMITED.

ABACUS PHARMA (AFRICA) LIMITED

MERIDIAN ENTERPRISES PRIVATE LIMITED.

ABACUS PHARMA (AFRICA) LIMITED

MERIDIAN ENTERPRISES PRIVATE LIMITED.

ABACUS PHARMA (AFRICA) LIMITED

MERIDIAN ENTERPRISES PRIVATE LIMITED.

ABACUS PHARMA (AFRICA) LIMITED

SUPPOL 250 SUPPOSITORIES

MERCK SHARP & DOHME INTAPHARMA

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

MACK BROWN PHARMACEUTICALS PVT LIMITED

COLDROP HERBAL COUGH SYRUP

Page 215: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1362 MICRO LABS LIMITED BACTOCLAV-1000

NDA/MAL/HDP/0787 MICRO LABS LIMITED BACTOCLAV DRY SYRUP

NDA/MAL/HDP/1528 MICRO LABS LTD BACTOCLAV-625

NDA/MAL/HDP/6226 IDA FOUNDATION KIMSY MEDS LTD

NDA/MAL/HDP/1101 MICRO LABS LTD GRAMOCEF-O 100

NDA/MAL/HDP/6052 MICRO LABS LTD MICROPIME

NDA/MAL/HDP/2315 MICRO LABS LTD GRAMOCEF-O-50

NDA/MAL/HDP/2900 MICRO LABS LTD GRAMOCEF-O-200

NDA/MAL/HDP/8254 MICRO LABS LTD GRAMOCEF-CV

NDA/MAL/HDP/1527 MICRO LABS LTD BACTOCLAV

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

AMOXICILLIN 500+ CLAVULANIC ACID 125MG BP

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

Page 216: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0926 MICRO LABS LIMITED BACTOCLAV-375

NDA/MAL/HDP/0427 MICRO LABS LTD AMLOZAAR -H

NDA/MAL/HDP/1098 IDA FOUNDATION KIMSY MEDS LTD PRAZIQUANTEL

NDA/MAL/HDP/1307 MICRO LABS LTD ARBITEL 40

NDA/MAL/HDP/8222 MICRO LABS LTD LUBREX

NDA/MAL/HDP/1006 MICRO LABS LTD TRIPRIDE-2

NDA/MAL/HDP/4151 IDA KIMSY MEDS LTD AMITRIPTYLINE

NDA/MAL/HDP/5095 MICRO LABS LTD DIAPRIDE PLUS

NDA/MAL/HDP/6050 MICRO LABS LTD ITACARE

NDA/MAL/HDP/2473 MICRO LABS LTD NUGREL

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 217: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6238 MICRO LABS LIMITED NEBILONG -AM

NDA/MAL/HDP/6613 MICRO LABS LIMITED OLMAT-40

NDA/MAL/HDP/7238 MICRO LABS LIMITED NEBILONG-10

NDA/MAL/HDP/7298 MICRO LABS LIMITED NEBILONG-2.5

NDA/MAL/HDP/8333 AVAS-20

NDA/MAL/HDP/4129 IDA FOUNDATION KIMSY MEDS LTD PRAZIQUANTEL

NDA/MAL/HDP/0811 MICRO LABS LIMITED DOLOWIN -SR

NDA/MAL/HDP/0544 MICRO LABS LIMITED DOLOWIN PLUS

NDA/MAL/HDP/1095 MICRO LABS LTD EROSTINE-20

NDA/MAL/HDP/0370 MICRO LABS LTD NEBILONG-H

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

MICRO LABS LTD 92 SIPCOT INDUSTRIAL

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 218: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0322 MICRO LABS LTD NEBILONG-5

NDA/MAL/HDP/1347 MICRO LABS LIMITED ORNILOX

NDA/MAL/HDP/1209 MICRO LABS LTD ARBITEL-80

NDA/MAL/HDP/0596 MICRO LABS LTD ARBITEL-H

NDA/MAL/HDP/3850 MICRO LABS LTD ANGIZAAR-H

NDA/MAL/HDP/4113 MICRO LABS LTD EROSTIN 10

NDA/MAL/HDP/4986 IDA FOUNDATION KIMSY MEDS LTD CO-TRIMOXAZOLE

NDA/MAL/HDP/5092 MICRO LABS LTD 92 SIPCOT DIAPRIDE

NDA/MAL/HDP/5395 MICRO LABS LTD OFLOX

NDA/MAL/HDP/1800 MICRO LABS LIMITED AMLONG-10

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 219: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2033 MICRO LABS LTD ANGIZAAR-50

NDA/MAL/HDP/2094 MICRO LABS LTD LEVOBACT-750

NDA/MAL/HDP/2581 MICRO LABS LTD AVAS-10

NDA/MAL/HDP/3186 IDA FOUNDATION KIMSY MEDS LTD PARACETAMOL

NDA/MAL/HDP/3712 MICRO LABS LTD AMLOZAAR

NDA/MAL/HDP/0751 MICRO LABS LIMITED DOLOWIN

NDA/MAL/HDP/0759 MICRO LABS LTD COTRIMOXAZOLE

NDA/MAL/HDP/0538 MICRO LABS LTD XONADINE 180

NDA/MAL/HDP/0541 MICRO LABS LTD XONADINE 120

NDA/MAL/HDP/1304 MICRO LABS LTD DIAPRIDE PLUS 2

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 220: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0428 MICRO LABS LTD MICROMOX-400

NDA/MAL/HDP/0691 MICRO LABS LTD OLMAT-20

NDA/MAL/HDP/1581 MICRO LABS LTD PANTOTAB

NDA/MAL/HDP/1773 MICRO LABS LTD LEVOBACT 500

NDA/MAL/HDP/2171 IDA KIMSY MEDS LTD CO-TRIMOXAZOLE

NDA/MAL/HDP/2318 MICRO LABS LTD DIAPRIDE-4

NDA/MAL/HDP/2628 MICRO LABS LTD AZILIDE-500

NDA/MAL/HDP/7903 MICRO LABS LIMITED MELMET-1000SR

NDA/MAL/HDP/8331 MICRO LABS LIMITED TORSINEX-20

NDA/MAL/HDP/0273 MICRO LABS LTD PULMOCEF-1500

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

Page 221: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2990 MICRO LABS LTD PULMOCEF-500

NDA/MAL/HDP/0599 MICRO LABS LTD GRAMOCEF-O-400

NDA/MAL/HDP/1732 MICRO LABS LTD CEFEX-250

NDA/MAL/HDP/1665 AGOG PHARMA LTD AGOXIN CAPSULES

NDA/MAL/HDP/2074 AGOG PHARMA LIMITED AGOXIN ORAL SUSPENSION

NDA/MAL/HDP/3561 AGOG PHARMA LTD

NDA/MAL/HDP/6247 MILOXY 250-DT

NDA/MAL/HDP/3279 ROYAL GROUP HAEMOFORTE SYRUP

NDA/MAL/HDP/4146 AGOG PHARMA LIMITED AGOMPICLOX

NDA/MAL/HDP/6211 EXPHAR SA CLOFAINS

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

AGOCILLIN ORAL SUSPENSION

MILAN LABORATORIES LTD (INDIA) PVT LTD

GITTOES PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

GITTOES PHARMACEUTICALS LIMITED

SURGIPHARM (U) LIMITED

Page 222: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1971 AGOG PHARMA LIMITED

NDA/MAL/HDP/3198 AGOG PHARMA LIMITED AGOPEN-125

NDA/MAL/HDP/3525 AGOG PHARMA LIMITED AGOCLLIN

NDA/MAL/HDP/1053 AGOG PHARMA LIMITED AGOXIN-125 DT

NDA/MAL/HDP/0795 AGOG PHARMA LTD AGOPEN-250

NDA/MAL/HDP/3967 AGOG PHARMA LIMITED AGOCLOX-125

NDA/MAL/HDP/1955 MILAN LABORATORIES LTD MILCILLIN

NDA/MAL/HDP/1956 MILAN LABORATORIES LTD MILOXY

NDA/MAL/HDP/1957 MILAN LABORATORIES LTD MILCILLIN

NDA/MAL/HDP/1958 MILAN LABORATORIES LTD MILOXY

GITTOES PHARMACEUTICALS LIMITED

AGOMPICLOX ORAL SUSPENSION

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 223: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1959 BETRIM 480

NDA/MAL/HDP/1963 DICLOFENAC GEL

NDA/MAL/HDP/1964 MILAN LABORATORIES LTD CLONEX

NDA/MAL/HDP/3482 AGOG PHARMA LIMITED AGOCLOX-250

NDA/MAL/HDP/0292 MILAN LABORATORIES LTD

NDA/MAL/HDP/6034 AGOG PHARMA LIMITED AGOXIN -250 DT

NDA/MAL/HDP/1465 NORVATIS PHARMA AG VOLTFAST

NDA/MAL/HDP/3019 MJ BIOPHARM PRT LTD TATA UGANDA LIMITED BIOSULIN 30/70

NDA/MAL/HDP/1943 NITROCONTIN 2.6

NDA/MAL/HDP/2838 DILCONTIN XL 120

MILAN LABERATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

MILAN LABERATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

NAZANEEN ANTACID SUSPENSION

GITTOES PHARMACEUTICALS LTD - WILLIAM STREET

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

Page 224: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3207 DILCONTIN XL 90

NDA/MAL/HDP/3465 FECONTIN-Z

NDA/MAL/HDP/3630 UNICONTIN 600

NDA/MAL/HDP/3641 TRD-CONTIN 100

NDA/MAL/HDP/3648 UNICONTIN 400

NDA/MAL/HDP/3672 NITROCONTIN 6.4

NDA/MAL/HDP/3896 VALCONTIN 500

NDA/MAL/HDP/3913 VALCONTIN

NDA/MAL/HDP/4143 TAM CONTIN 0.4

NDA/MAL/HDP/3214 INDICONTIN

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MONDI-MUNDI PHARMA PVT LIMITED

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI NUNDIPHARMA PVT LTD

SURGIPHARM (U) LIMITED

MODI MUNDI PHARMA PVT LTD

SURGIPHARM (U) LIMITED

Page 225: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4142 DAFRA PHARMA LTD CO-ARTESAINE

NDA/MAL/HDP/7651 MSD (PTY) LTD JANUVIA 25

NDA/MAL/HDP/7652 MSD (PTY) LTD JANUVIA 100

NDA/MAL/HDP/7653 MSD (PTY) LTD JANUVIA 50

NDA/MAL/HDP/4173 MSD (PTY) LIMITED SA NASONEX

NDA/MAL/HDP/0103 MSN LABORATORIES LTD ATOREM 20

NDA/MAL/HDP/0412 MSN LABORATORIES LTD LDNIL 5

NDA/MAL/HDP/0410 MSN LABORATORIES LTD LDNIL 20

NDA/MAL/HDP/0145 KIMSY MEDS LTD TELKAST 10

NDA/MAL/HDP/0114 MSN LABORATORIES LTD BREATHEZY 4

LABOREX UGANDA LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

GOOD DAY PHARMACY LIMITED

Page 226: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0408 MSN LABORATORIES LTD ALGIC - P

NDA/MAL/HDP/0098 MSN LABORATORIES LTD ATOREM 10

NDA/MAL/HDP/0168 MSN LABORATORIES LTD FEBUDAY

NDA/MAL/HDP/0182 MSN LABORATORIES LTD FEBUDAY 40

NDA/MAL/HDP/0177 MSN LABORATORIES LTD ILET B2

NDA/MAL/HDP/0144 KIMSY MEDS LTD NEXQUIN 500

NDA/MAL/HDP/0097 MSN LABORATORIES LTD SAFELEVO 750

NDA/MAL/HDP/0116 MSN LABORATORIES LTD BREATHEZY CW 5

NDA/MAL/HDP/0158 KIPEL 10

NDA/MAL/HDP/0533 KIMSY MEDS LTD TELKAST 5

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

GOOD DAY PHARMACY LIMITED

STAR PHARMACEUTICALS LTD

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

Page 227: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0539 KIMSY MEDS LTD TELKAST 4

NDA/MAL/HDP/0860 MSN LABORATORIES LTD FLOXSAFE 400

NDA/MAL/HDP/0493 MSN LABORATORIES LTD PRASUSAFE 10

NDA/MAL/HDP/0772 LIGABA - 150

NDA/MAL/HDP/0775 LIGABA - 75

NDA/MAL/HDP/0102 MSN LABORATORIES LTD SILMELT 100

NDA/MAL/HDP/0104 MSN LABORATORIES LTD SILMELT 50

NDA/MAL/HDP/0110 MSN LABORATORIES LTD SAFETELMI 40

NDA/MAL/HDP/0111 MSN LABORATORIES LTD SAFETELMI 80

NDA/MAL/HDP/0151 KIMSY MEDS LTD CARDITEL 80

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

Page 228: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0206 KIMSY MEDS LTD CARDITEL 40

NDA/MAL/HDP/4324 MSN LABORATORIES LTD PRASUSAFE 5

NDA/MAL/HDP/4559 MSN LABORATORIES LTD PREGASAFE 75

NDA/MAL/HDP/2298 MSN LABORATORIES LTD SAFELEVO 500

NDA/MAL/HDP/3399 MSN LABORATORIES LTD LDNIL 10

NDA/MAL/HDP/0421 MSN LABORATORIES LTD PREGASAFE 150

NDA/MAL/HDP/4480 KIPEL 5

NDA/MAL/HDP/4480 KIPEL 5

NDA/MAL/HDP/5493

NDA/MAL/HDP/2927

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

GOOD DAY PHARMACY LIMITED

STAR PHARMACEUTICALS LTD

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ASTRA PHARMA (U) LIMITED

MEGA LIFESCIENCES (AUSTRALIA) PTY LTD

ABACUS PHARMA (AFRICA) LIMITED

LORDS HEALTHCARE LIMITED

SURGIPHARM (U) LIMITED

BETADINE MOUTH WASH GARGLE

LORDS HEALTHCARE LIMITED

SURGIPHARM (U) LIMITED

BETADINE ANTISEPTIC SOLUTION

Page 229: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2928

NDA/MAL/HDP/3010

NDA/MAL/HDP/3324

NDA/MAL/HDP/8084 KIMSY MEDS LTD TAZPEN

NDA/MAL/HDP/7701 KIMSY MEDS LTD

NDA/MAL/HDP/0079 REVOKE 72

NDA/MAL/HDP/0636 REVOKE-1.5

NDA/MAL/HDP/0083 ZINNIA-F

LORDS HEALTHCARE LIMITED

SURGIPHARM (U) LIMITED

BETADINE SURGICAL SCRUB

LORDS HEALTHCARE LIMITED

SURGIPHARM (U) LIMITED

BETADINE OINTMENT 10%W/W

LORDS HEALTH CARE LIMITED

SURGIPHARM (U) LIMITED

BETADINE VAGINAL DOUCHE

AGILA SPECIALTIES PRIVATE LIMITED

VISSCO REHAILITATION AIDS PVT LTD

FLUCONAZOLE TABLETS 200 MG

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

Page 230: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1023 ZINNIA P

NDA/MAL/HDP/1547 LUSIA-F

NDA/MAL/HDP/4998 HYAN

NDA/MAL/HDP/2100 ORALCON - F

NDA/MAL/HDP/2459 P2

NDA/MAL/HDP/6046 KIMSY MEDS LTD ACYCLOVIR

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED.

NORVIK ENTERPRISES LIMITED

MYLAN LABORATORIES LIMITED

Page 231: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6205 KIMSY MEDS LTD ACICLOVIR

NDA/MAL/HDP/6227 KIMSY MEDS LTD ISONIAZID

NDA/MAL/HDP/3047 KIMSY MEDS LTD

NDA/MAL/HDP/3461 KIMSY MEDS LTD ZIDOVUDINE

NDA/MAL/HDP/6826 KIMSY MEDS LTD ZINC SULFATE

NDA/MAL/HDP/7710 KIMSY MEDS LTD FLUCONAZOLE

NDA/MAL/HDP/5222 KIMSY MEDS LTD

NDA/MAL/HDP/8082 KIMSY MEDS LTD

NDA/MAL/HDP/8133 KIMSY MEDS LTD MYHEP

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

ABACAVIR SULFATE+LAMIVUDINE+ZIDOVUDINE

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED.

MYLAN PHARMACEUTICAL PRIVATE LIMITED, INDIA

EMTRICITABINE+TENOFOVIR DF

MYLAN LABORATORIES LIMITED

ABACAVIR SULFATE + LAMIVUDINE

MYLAN LABORATORIES LIMITED

Page 232: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0505 KIMSY MEDS LTD OSELTAMIVIR PHOSPHATE

NDA/MAL/HDP/1334 KIMSY MEDS LTD OSELTAMIVIR PHOSPHATE

NDA/MAL/HDP/1336 KIMSY MEDS LTD OSELTAMIVIR PHOSPHATE

NDA/MAL/HDP/0237 KIMSY MEDS LTD KOMEFAN 280

NDA/MAL/HDP/0239 KIMSY MEDS LTD KOMEFAN 140

NDA/MAL/HDP/4280 KIMSY MEDS LTD

NDA/MAL/HDP/4396 KIMSY MEDS LTD ABACAVIR SULPHATE

NDA/MAL/HDP/2047 KIMSY MEDS LTD RITONAVIR

NDA/MAL/HDP/2104 KIMSY MEDS LTD

NDA/MAL/HDP/2112 KIMSY MEDS LTD LOPINAVIR + RITONAVIR

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

ABACAVIR SULFATE+LAMIVUDINE

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

MYLAN LABORATORIES LIMITED

Page 233: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2715 KIMSY MEDS LTD LAMIVUDINE

NDA/MAL/HDP/3136 KIMSY MEDS LTD

NDA/MAL/HDP/3192 KIMSY MEDS LTD ANZAVIR-R

NDA/MAL/HDP/3296 KIMSY MEDS LTD LOPINAVIR / RITONAVIR

NDA/MAL/HDP/3455 KIMSY MEDS LTD

NDA/MAL/HDP/1205 KIMSY MEDS LTD EFAVIRENZ

NDA/MAL/HDP/2267 KIMSY MEDS LTD

NDA/MAL/HDP/2258 KIMSY MEDS LTD

NDA/MAL/HDP/3261 KIMSY MEDS LTD

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

TENOFOVIR DISOPROXIL FUMARATE

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

LAMIVUDINE + ZIDOVUDINE

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED.

TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE

MYLAN LABORATORIES LIMITED

TENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ

MYLAN LABORATORIES LIMITED

TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ

Page 234: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4131 KIMSY MEDS LTD NEVIRAPINE

NDA/MAL/HDP/2290 KIMSY MEDS LTD

NDA/MAL/HDP/3024 KIMSY MEDS LTD

NDA/MAL/HDP/0013 MSD (PTY) LIMITED SA IMPLANON NXT

NDA/MAL/HDP/5065 N.V. ORGANON MARVELON

NDA/MAL/HDP/0637 ZUDICORT

NDA/MAL/HDP/1457 DYSEN FORTE

NDA/MAL/HDP/5078 GLANDIN E2 VAGINAL

NDA/MAL/HDP/5129 KLEEN ENEMA

MYLAN LABORATORIES LIMITED

MYLAN LABORATORIES LIMITED

LAMIVUDINE + ZIDOVUDINE

MYLAN LABORATORIES LIMITED

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

NABIQASIM INDUSTRIES (PVT) LIMITED

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LIMITED

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LTD.

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LTD.

JEET PHARMACEUTICALS LIMITED

Page 235: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2281 SURGE LAB (PVT) LIMITED LUMFORT

NDA/MAL/HDP/2284 SURGE LAB (PVT) LIMITED LUMFORT SYRUP

NDA/MAL/HDP/7905 ACEFYL

NDA/MAL/HDP/0059 VAGIBACT CREAM

NDA/MAL/HDP/1824 GLANDIN E2 GEL

NDA/MAL/HDP/1274 SURGE LAB (PVT) LIMITED ROMYCIN

NDA/MAL/HDP/1409 SURGE LAB (PVT) LIMITED ROMYCIN

NDA/MAL/HDP/4277 VIVIRON PLUS SYRUP

NDA/MAL/HDP/1935 SULPHA KREAM-N

NDA/MAL/HDP/1727 MISSION PHARMA

JEET PHARMACEUTICALS LIMITED

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LTD.

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LTD.

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LIMITED

JEET PHARMACEUTICALS LIMITED

JEET PHARMACEUTICALS LIMITED

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LIMITED

JEET PHARMACEUTICALS LIMITED

NABIQASIM INDUSTRIES (PVT) LTD.

JEET PHARMACEUTICALS LIMITED

JOINT MEDICAL STORE (UPMB - UCMB)

TETRACYCLINE HYDROCLORIDE

Page 236: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0042 AIVEEN (U) LIMITED CISPLATIN

NDA/MAL/HDP/0038 AIVEEN (U) LIMITED ARZI 200

NDA/MAL/HDP/0036 AIVEEN (U) LIMITED

NDA/MAL/HDP/0039 AIVEEN (U) LIMITED NZYTOP

NDA/MAL/HDP/0037 AIVEEN (U) LIMITED L-ASPASE

NDA/MAL/HDP/0044 AIVEEN (U) LIMITED NAPRO-TAX

NDA/MAL/HDP/0814 AIVEEN (U) LIMITED CANCYT

NDA/MAL/HDP/1404 AIVEEN (U) LIMITED NAPRODOX-10

NDA/MAL/HDP/3386 AIVEEN (U) LIMITED AMBROSE 2

NDA/MAL/HDP/3410 AIVEEN (U) LIMITED NAPRODOX-50

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

DOCETAXEL FOR INJECTION

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

MIRACALUS PHARMA PVT.LTD

Page 237: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0046 AIVEEN (U) LIMITED ABINGEM

NDA/MAL/HDP/0815 ABINGEM-200

NDA/MAL/HDP/4746 AIVEEN (U) LIMITED ABINGEM-200

NDA/MAL/HDP/5385 AIVEEN (U) LIMITED VINROS A-1

NDA/MAL/HDP/6120 KMINE

NDA/MAL/HDP/7227 NEMADOL 50

NDA/MAL/HDP/8320 STACEF 1 GM

NDA/MAL/HDP/7230 HISTABLOC 2ML

NDA/MAL/HDP/8393 NACLOR EYE DROPS 10ML

NDA/MAL/HDP/7721 SANOFI-AVENTIS KENYA

MIRACALUS PHARMA PVT.LTD

NAPROD LIFE SCIENCES PVT LTD

AIVEEN (U) LTD - WILSON ROAD

MIRACALUS PHARMA PVT.LTD

NAPROD LIFE SCIENCES PVT LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

NATIONAL HEALTHCARE PVT LTD

ANDYCO PHARMACY (UGANDA) LTD

LABOREX UGANDA LIMITED

MAALOX LEMON FLAVORING

Page 238: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7722 SANOFI-AVENTIS KENYA MAALOX MINT FLAVORING

NDA/MAL/HDP/0907 NECTAR LIFESCIENCES LTD AIVEEN (U) LIMITED CEFUAXIT

NDA/MAL/HDP/1057 NECTAR LIFESCIENCES LTD SUPER MEDIC LTD FIXINECT-200MG

NDA/MAL/HDP/1074 NECTAR LIFESCIENCES LTD SUPER MEDIC LTD CEFUAXIT

NDA/MAL/HDP/0468 NECTAR LIFESCIENCES LTD AIVEEN (U) LIMITED CEFUAXIT 750

NDA/MAL/HDP/1075 NECTAR LIFESCIENCES LTD AIVEEN (U) LIMITED NECPIME

NDA/MAL/HDP/0909 NECTAR LIFESCIENCES LTD AIVEEN (U) LIMITED FIXINECT

NDA/MAL/HDP/0905 NECTAR LIFESCIENCES LTD AIVEEN (U) LIMITED NECPOD

NDA/MAL/HDP/1077 NECTAR LIFESCIENCES LTD AIVEEN (U) LIMITED NECTRAM

NDA/MAL/HDP/1086 RENE PHARMACY LTD SYNOGEN TABLETS

LABOREX UGANDA LIMITED

NEM LABORATORIES PRIVATE LIMITED

Page 239: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1114 RENE PHARMACY LTD TRANGEL ULTRA

NDA/MAL/HDP/1163 RENE PHARMACY LTD FRUSEMIDE

NDA/MAL/HDP/1116 RENE PHARMACY LTD VITAL ESSENTIAL BALM

NDA/MAL/HDP/1117 RENE PHARMACY LTD

NDA/MAL/HDP/1418 RENE PHARMACY LTD AMINOPHYLLINE TABLETS

NDA/MAL/HDP/4038 RENE PHARMACY LTD PREDSONE-5

NDA/MAL/HDP/4794 RENE PHARMACY LTD DALADOL

NDA/MAL/HDP/5442 RENE PHARMACY LTD

NDA/MAL/HDP/6067 RENE PHARMACY(R) LTD.. RENE PHARMACY LTD DIAZEPAM

NDA/MAL/HDP/6220 RENE PHARMACY LTD METHYLDOPA

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

TETRACYCLINE EYE OINTMENT USP 1%

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

CHLORAMPHENICOL OPHTHALMIC OINTMENT USP 1%

NEM LABORATORIES PRIVATE LIMITED

Page 240: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1061 RENE PHARMACY LTD BISALAX

NDA/MAL/HDP/1517 RENE PHARMACY LTD VEST MENTAMU BALM

NDA/MAL/HDP/0639 RENE PHARMACY LTD RHEUMATIC CREAM

NDA/MAL/HDP/3993 RENE PHARMACY LTD NEM SCAB

NDA/MAL/HDP/5155 RENE PHARMACY LTD BETAVEL

NDA/MAL/HDP/5157 RENE PHARMACY LTD BETAVEL N

NDA/MAL/HDP/5356 RENE PHARMACY LTD BURNNEM

NDA/MAL/HDP/1680 RENE PHARMACY LTD H-CORT

NDA/MAL/HDP/2042 RENE PHARMACY LTD BURNCURE

NDA/MAL/HDP/2472 RENE PHARMACY LTD TRAN-GEL

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

Page 241: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2908 RENE PHARMACY LTD

NDA/MAL/HDP/3233 RENE PHARMACY LTD WHITFIELD'S OINTMENT BP

NDA/MAL/HDP/3259 RENE PHARMACY LTD TIGBODERM

NDA/MAL/HDP/3637 RENE PHARMACY LTD TINODERM

NDA/MAL/HDP/2427 RENE PHARMACY LTD CLONEM

NDA/MAL/HDP/2523 RENE PHARMACY LTD SULPHUR OINTMENT

NDA/MAL/HDP/5114 RENE PHARMACY LTD LATONE MULTIVITAMIN

NDA/MAL/HDP/5207 RENE PHARMACY LTD DIGOXIN TABLETS

NDA/MAL/HDP/0409 NEON LABARATORIES LTD AIVEEN (U) LIMITED TYDE-S*

NDA/MAL/HDP/0413 NEON LABARATORIES LTD AIVEEN (U) LIMITED XSPAS

NEM LABORATORIES PRIVATE LIMITED

PAINGO MEDICATED CREAM

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

NEM LABORATORIES PRIVATE LIMITED

Page 242: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0407 NEON LABARATORIES LTD AIVEEN (U) LIMITED NEOROF

NDA/MAL/HDP/0403 NEON LABARATORIES LTD AIVEEN (U) LIMITED SUPRIDOL

NDA/MAL/HDP/0954 NEON LABARATORIES LTD AIVEEN (U) LIMITED ANAWIN

NDA/MAL/HDP/0952 NEON LABARATORIES LTD AIVEEN (U) LIMITED EFECATAL

NDA/MAL/HDP/0953 NEON LABARATORIES LTD AIVEEN (U) LIMITED CIZCAN

NDA/MAL/HDP/0405 NEON LABARATORIES LTD AIVEEN (U) LIMITED CHEMLET

NDA/MAL/HDP/1012 NEON LABARATORIES LTD AIVEEN (U) LIMITED LOX 2%

NDA/MAL/HDP/0406 NEON LABARATORIES LTD AIVEEN (U) LIMITED EVATOCIN

NDA/MAL/HDP/0951 NEON LABARATORIES LTD AIVEEN (U) LIMITED NORAD

NDA/MAL/HDP/1013 NEON LABARATORIES LTD AIVEEN (U) LIMITED THIOSOL

Page 243: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2712 NEON LABARATORIES LTD AIVEEN (U) LIMITED ANAWIN

NDA/MAL/HDP/6685 NEON LABARATORIES LTD AIVEEN (U) LIMITED EVACEF

NDA/MAL/HDP/5068

NDA/MAL/HDP/0873 OXYTOCIN INJECTION

NDA/MAL/HDP/3893

NDA/MAL/HDP/4183 CHLORPROMAZINE

NDA/MAL/HDP/2253 INDOMETHACIN

NDA/MAL/HDP/3422

NDA/MAL/HDP/1344 LIDOCAINE

NDA/MAL/HDP/2508 HYOSCINE

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

DEXAMETHASONE SODIUM PHOSPHATE

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

EPINEPHRINE INJECTION USP

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GENTAMICIN EYE/ EAR DROPS

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 244: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4968 FRUSEMIDE INJECTION

NDA/MAL/HDP/5221 DICLOFENAC SODIUM

NDA/MAL/HDP/2216 METOCLOPRAMIDE

NDA/MAL/HDP/2217 AMINOPHYLINE

NDA/MAL/HDP/2289 CHLORAMPHENICOL

NDA/MAL/HDP/2356 QUININE

NDA/MAL/HDP/2363 GENTAMICIN SULPHATE

NDA/MAL/HDP/1499 PROMETHAZINE

NDA/MAL/HDP/4050

NDA/MAL/HDP/4291

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

CHLORAMPHENICOL EYE DROPS

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

VITAMIN B COMPLEX INJECTION

Page 245: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2039 RANITIDINE INJECTION USP

NDA/MAL/HDP/2610 ATROPINE

NDA/MAL/HDP/3360

NDA/MAL/HDP/3412 TETRACYCLINE

NDA/MAL/HDP/3807 ARTEMETHER INJECTION

NDA/MAL/HDP/3925

NDA/MAL/HDP/7263 NIPRO MIDDLE EAST FZE VERMIKIL TABLET

NDA/MAL/HDP/4868 SUPER MEDIC LTD FLUCANIR

NDA/MAL/HDP/5158 NIRMA LIMITED. SUPER MEDIC LTD KETANIR

NDA/MAL/HDP/6224 NITIN LIFESCIENCES LTD HEALTHCARE LTD. NICLOFEN

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

CHLORAMPHENICOL EAR DROPS

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

CALCIUM GLUCONATE INJECTION

ROYAL PHARMA 2011 LIMITED

NIRMA LIMITED (HEALTHCARE DI VISION) NIRLIFE HEALTHCARE

Page 246: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7709 NITIN LIFESCIENCES LTD HEALTHCARE LTD.

NDA/MAL/HDP/0820 MERCK (PTY) LTD FIXIME 400MG

NDA/MAL/HDP/7688 MERCK (PTY) LTD

NDA/MAL/HDP/7784 DAFRA PHARMA GMBH LORATOL

NDA/MAL/HDP/8650 CORE ACCESS LIMITED CEFDIA 400MG

NDA/MAL/HDP/3844 NOVARTIS PHARMA AG VOLTAREN RETARD

NDA/MAL/HDP/0654 NVS KENYA LTD GALVUS MET

NDA/MAL/HDP/0657 NVS KENYA LTD GALVUS MET

NDA/MAL/HDP/0658 NVS KENYA LTD GALVUS MET

NDA/MAL/HDP/3753 NOVARTIS PHARMA AG MYFORTIC 180

DEXAMETHASONE SODIUM PHOSPHATE

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

GLUCOPHAGE 850MG TABLET

LABOREX UGANDA LIMITED

İLKO İLAÇ SANAYI VE TICARET A. Ş.

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 247: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0797 NVS KENYA LTD AFINITOR 5MG

NDA/MAL/HDP/0799 NVS KENYA LTD AFINITOR 10MG

NDA/MAL/HDP/0913 NOVARTIS PHARMA FEMARA

NDA/MAL/HDP/6051

NDA/MAL/HDP/3931 COARTEM 80/480

NDA/MAL/HDP/3649 NOVARTIS PHARMA AG LAMISIL

NDA/MAL/HDP/1450 VOLTAREN EMULGEL 1%

NDA/MAL/HDP/1450 VOLTAREN EMULGEL 1%

NDA/MAL/HDP/2471 GLAXOSMITHKLINE LIMITED-

NDA/MAL/HDP/2875 GLAXOSMITHKLINE LIMITED-

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES

SURGIPHARM (U) LIMITED

EXFORGE HCT 10MG + 320MG + 25MG

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

GLAXOSMITHKLINE LIMITED LIKONI

SURGIPHARM (U) LIMITED

GLAXOSMITHKLINE LIMITED LIKONI

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

OTRIVIN 0.1% NASAL DROPS

SURGIPHARM (U) LIMITED

OTRIVIN 0.05% NASAL DROPS

Page 248: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5357 GLAXOSMITHKLINE LIMITED- CA-C 1000

NDA/MAL/HDP/3643 GLAXOSMITHKLINE LIMITED LAMISIL CREAM

NDA/MAL/HDP/3852 GLAXOSMITHKLINE LIMITED PROCTO GLYVENOL

NDA/MAL/HDP/2858 GLAXOSMITHKLINE LTD VIBROCIL

NDA/MAL/HDP/1650 NOVARTIS PHARMA AG TEGRETOL CR 200

NDA/MAL/HDP/2236 NOVARTIS PHARMA AG TEGRETOL 200

NDA/MAL/HDP/1770 NOVARTIS PHARMA AG DIOVAN 160MG TABLETS

NDA/MAL/HDP/2777 NOVARTIS PHARMA AG

NDA/MAL/HDP/2780 NOVARTIS PHARMA AG

NDA/MAL/HDP/1969 NOVARTIS PHARMA AG VOLTAREN SR 75MG

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

CO-DIOVAN 160/12.5MG TABLETS

SURGIPHARM (U) LIMITED

CO-DIOVAN 160/25MG TABLETS

SURGIPHARM (U) LIMITED

Page 249: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2714 NOVARTIS PHARMA AG ANAFRANIL

NDA/MAL/HDP/8073 NOVARTIS PHARMA AG TRILEPTAL

NDA/MAL/HDP/3433 NOVARTIS PHARMA AG CO-DIOVAN 80/12.5

NDA/MAL/HDP/4415 NOVARTIS PHARMA AG CATAFLAM 5OMG TABLETS

NDA/MAL/HDP/5364 NOVARTIS PHARMA AG CATAFLAM 25MG TABLETS

NDA/MAL/HDP/5365 NORVATIS PHARMA AG CATAFLAM ORAL DROPS

NDA/MAL/HDP/8207 ZOMETA

NDA/MAL/HDP/6396 NVS KENYA LTD LETROZOLE 2.5

NDA/MAL/HDP/6692 ASUNRA 100

NDA/MAL/HDP/6736 SANDOSTATIN

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

Page 250: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6738 SEEBRI BREEZHALER

NDA/MAL/HDP/6741 NVS KENYA LTD ULTIBRO BREEZHALER

NDA/MAL/HDP/8152 JAKAVI

NDA/MAL/HDP/8155 JAKAVI

NDA/MAL/HDP/7673 VALSARTAN

NDA/MAL/HDP/7675 VALSARTAN

NDA/MAL/HDP/8150 JAKAVI

NDA/MAL/HDP/0107 NVS KENYA LTD ASUNRA

NDA/MAL/HDP/6154 EXFORGE 5MG/320MG

NDA/MAL/HDP/0458 NOVARTIS PHARMA AG EXFORGE 5MG/80MG

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 251: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0112 NORVATIS PHARMA AG EXFORGE 5MG/160MG

NDA/MAL/HDP/3414 NOVARTIS PHARMA AG EXFORGE 10MG/160MG

NDA/MAL/HDP/0802 NOVARTIS PHARMA AG

NDA/MAL/HDP/1451 NOVARTIS PHARMA AG VOLTAREN INJECTION

NDA/MAL/HDP/3943 NVS KENYA LTD SYNTOCINON

NDA/MAL/HDP/4615 NVS KENYA LTD TASIGNA 150

NDA/MAL/HDP/3092

NDA/MAL/HDP/3596 NORVATIS PHARMA AG SYNTOCINON

NDA/MAL/HDP/0652 NVS KENYA LTD GALVUS

NDA/MAL/HDP/7202 VILDAGLIPTIN

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

EXFORGE HCT 5MG/ 160MG/12.5MG

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

EXFORGE HCT 10MG/160MG/12.5MG

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

Page 252: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3883 NOVARTIS PHARMA AG MYFORTIC 360

NDA/MAL/HDP/3883 NOVARTIS PHARMA AG MYFORTIC 360

NDA/MAL/HDP/2240 NOVARTIS PHARMA AG DIOVAN 80

NDA/MAL/HDP/2470 GLAXOSMITHKLINE LTD EURAX

NDA/MAL/HDP/0470 NOVOMIX 30 FLEXPEN

NDA/MAL/HDP/0471 NOVORAPID FLEXPEN

NDA/MAL/HDP/4908 NOVO NORDISK MIXTARD 30 PENFILL

NDA/MAL/HDP/5104 LEVEMIR FLEXPEN

NDA/MAL/HDP/4904 NOVO NORDISK MIXTARD 30

NDA/MAL/HDP/5131 NOVO NORDISK INSULATARD HM

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

NOVO NORDISK PHARMA GULF FZ-LC

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

NOVO NORDISK PHARMA GULF FZ-LC

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

STAR PHARMACEUTICALS LTD

NOVO NORDISK PHARMA GULF FZ-LC

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

Page 253: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5139 NOVO NORDISK INSULATARD HM PENFILL

NDA/MAL/HDP/2133 NOVO NORDISK ACTRAPID

NDA/MAL/HDP/2800 NOVO NORDISK ACTRAPID HM PENFILL

NDA/MAL/HDP/6123 OCTOBER PHARMA MONOMAK

NDA/MAL/HDP/5344 IDA FOUNDATION KIMSY MEDS LTD CEFTRIAXONE

NDA/MAL/HDP/2247 CIPLA LTD. ESOMAC

NDA/MAL/HDP/3302 CIPLA LTD

NDA/MAL/HDP/3333 CIPLA LTD. NOVACLAV-625

NDA/MAL/HDP/1533 5D

NDA/MAL/HDP/1377 WATER FOR INJECTION

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

QUALITY CHEMICALS LTD - HUMAN

QUALITY CHEMICALS LTD - HUMAN

AMOXICILLIN ORAL SUSPENSION

QUALITY CHEMICALS LTD - HUMAN

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

Page 254: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4016

NDA/MAL/HDP/4823 METRIS INFUSION

NDA/MAL/HDP/5348 CELEPID 20

NDA/MAL/HDP/5416 CIPROX

NDA/MAL/HDP/5472 NS

NDA/MAL/HDP/2263 CELEMIN 10 PLUS

NDA/MAL/HDP/3628 CELEMIN 5S

NDA/MAL/HDP/6532 BUNASE 200

NDA/MAL/HDP/1166 PANACEA BIOTEC LTD DOLZERO

NDA/MAL/HDP/5400 ERIS LTD ALBEN SUSPENSION

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

COMPOUND SODIUM LACATE INTRAVENOUS INFUSION

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

OTSUKA PHARMACEUTICAL INDIA PRIVATE LIMITED

REDDYS PHARMA LIMITED

MACLEODS PHARMACEUTICALS LTD.

NORVIK ENTERPRISES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 255: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3134 PANACEA BIOTEC LTD TOFF PLUS

NDA/MAL/HDP/6654 PANACEA BIOTEC LTD LIVOLUK FIBRE

NDA/MAL/HDP/6663 PANACEA BIOTEC LTD SITCOM

NDA/MAL/HDP/2510 PANACEA BIOTEC LTD GIRO

NDA/MAL/HDP/7313 PANACEA BIOTEC LTD

NDA/MAL/HDP/5413 EUVAX B (ADULT)

NDA/MAL/HDP/7258 GILEAD SCIENCE INC DESCOVY 200MG/10MG

NDA/MAL/HDP/8341 GILEAD SCIENCE INC GENVOYA

NDA/MAL/HDP/8660 GILEAD SCIENCE INC VEMLIDY

NDA/MAL/HDP/7396 GILEAD SCIENCE INC HARVONI

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

STAR PHARMACEUTICALS LTD

EASYFIVE-TT (FULLY LIQUID PENTAVALENT VACCINE)

PASTEUR MERIEUX CONNANGHT

LABOREX UGANDA LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

Page 256: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2556 GILEAD SCIENCE INC TRUVADA

NDA/MAL/HDP/8313

NDA/MAL/HDP/7348 MSD (PTY) LTD ISENTRESS 25 MG

NDA/MAL/HDP/8639 MSD (PTY) LTD ISENTRESS 100MG

NDA/MAL/HDP/3489 NEO MEDROL

NDA/MAL/HDP/2793 GILEAD SCIENCE INC VIREAD

NDA/MAL/HDP/3423 BENLE CONSULT LIMITED

NDA/MAL/HDP/8023 BENLE CONSULT LIMITED

NDA/MAL/HDP/3138 ANUSOL SUPPOSITORY

NDA/MAL/HDP/3457 ANUSOL OINTMENT

MEDICAL ACCESS (UGANDA) LIMITED

GLENMARK PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

FULYZAQ DELAYED RELEASE TABLETS

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

MEDICAL ACCESS (UGANDA) LIMITED

DENK PHARMA GMBH & CO KG

AMOXICLAV-DENK 1000/125

DENK PHARMA GMB H &CO. KG

AMOXICLAV-DENK 500/62.5

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 257: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8061 LYRICA 25MG

NDA/MAL/HDP/3887 LYRICA 150MG

NDA/MAL/HDP/3889 LYRICA 75MG

NDA/MAL/HDP/3102 EPANUTIN READY MIXED

NDA/MAL/HDP/0069 LIPITOR

NDA/MAL/HDP/0070 LIPITOR

NDA/MAL/HDP/4303 PFIZER LABORATORIES (PTY) SAYANA PRESS

NDA/MAL/HDP/4792 DALACIN C

NDA/MAL/HDP/5030 PFIZER LAB LTD SOLU-MEDROL

NDA/MAL/HDP/5040 DEPO-MEDROL

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD BELGIUM

LABOREX UGANDA LIMITED

Page 258: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2950 XALATAN

NDA/MAL/HDP/4056 FASIGYN

NDA/MAL/HDP/5140 DIFLUCAN

NDA/MAL/HDP/5251 DIFLUCAN

NDA/MAL/HDP/3368 VIAGRA 50MG

NDA/MAL/HDP/5027 PFIZER LAB LTD TERRA-CORTRIL

NDA/MAL/HDP/4789 DALACIN C

NDA/MAL/HDP/0980 AZOMYCIN

NDA/MAL/HDP/0972 AZOMYCIN

NDA/MAL/HDP/0975 CETRAK SYRUP

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

PHARCO PHARMACEUTICALS

ECHO PHARMACY (U) LIMITED

PHARCO PHARMACEUTICALS COMPANY LTD

ECHO PHARMACY (U) LIMITED

PHARCO PHARMACEUTICALS

ECHO PHARMACY (U) LIMITED

Page 259: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0977 CETRAK

NDA/MAL/HDP/3969

NDA/MAL/HDP/4714 CEPHOXIN 250MG/5ML

NDA/MAL/HDP/4778 CURISAFE

NDA/MAL/HDP/4799 CITROLIN SOLUTION

NDA/MAL/HDP/5087 DIABEN TABLETS

NDA/MAL/HDP/5183

NDA/MAL/HDP/5184 GYNOZOL VAGINAL CREAM

NDA/MAL/HDP/5250 FARCOLIN SYRUP

NDA/MAL/HDP/5253 FARCOZOL SUSPENSION

PHARCO PHARMACEUTICALS

ECHO PHARMACY (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

FAWAR FRUIT EFFERVESCENT GRANULES

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO B PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

GYNOZOL VAGINAL CAPSULES

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 260: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5343 CEFORAN 1GM

NDA/MAL/HDP/5453 FARCONCIL 250MG/5ML

NDA/MAL/HDP/5456 FARCONCIL 125MG/5ML

NDA/MAL/HDP/1778

NDA/MAL/HDP/2878 FARCOCIN CREAM

NDA/MAL/HDP/6412 BUCCAZOLE ORAL GEL

NDA/MAL/HDP/7093

NDA/MAL/HDP/7096 DEXAPHEN SYRUP

NDA/MAL/HDP/7124 VITAMIN E 400 MG.

NDA/MAL/HDP/7264 MIOPAN PLUS SUSPENSION

PHARCO PHARMACEUTICALS LTD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS LTD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS LTD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

FARCONCIL 500MG CAPSULES

PHARCO PHARMACEUTICALS LTD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS LTD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS LTD

WIDE SPECTRUM ENTERPRISES (U) LIMITED

DECLOPHEN 25 MG INFANTILE SUPPOSITORIES

GAMA PHARMACEUTICALS (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 261: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7291 DERMATIN CREAM

NDA/MAL/HDP/8218 DECLOPHEN 12.5

NDA/MAL/HDP/8219 DERMATIN

NDA/MAL/HDP/8287 DERMATIN 1% POWDER

NDA/MAL/HDP/8432 DECLOPHEN

NDA/MAL/HDP/4752 PFIZER LABORATORIES LTD ADRIBLASTINA RD

NDA/MAL/HDP/2196 PFIZER LABORATORIES LTD MYCOBUTIN

NDA/MAL/HDP/5254 PFIZER LABORATORIES LTD FARMORUBICIN RD

NDA/MAL/HDP/1558 GABBRORAL

NDA/MAL/HDP/4790 DALACIN C

PHARCO PHARMACEUTICALS

GAMA PHARMACEUTICALS (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO B PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

PHARCO PHARMACEUTICALS

GAMA PHARMACEUTICALS (U) LIMITED

PHARCO PHARMACEUTICALS

WIDE SPECTRUM ENTERPRISES (U) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

Page 262: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4791 DALACIN C

NDA/MAL/HDP/4793 DALACIN T

NDA/MAL/HDP/5044 DEPO-PROVERA

NDA/MAL/HDP/8062 PROSTIN E2

NDA/MAL/HDP/6766 ADCOCK INGRAM LIMITED LOCAINE A

NDA/MAL/HDP/5156 PHARMATHEN LTD IRIFONE GEL

NDA/MAL/HDP/2904 PHARMATHEN LTD NELTOLON SOLUTION

NDA/MAL/HDP/3537 PHARMATHEN LTD NELTOLON GEL

NDA/MAL/HDP/3819 PHARMATHEN LTD STRADUMEL

NDA/MAL/HDP/3891 PHARMATHEN S.A LADININ

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD BELGIUM

LABOREX UGANDA LIMITED

PFIZER LABORATORIES (PTY) LTD BELGIUM

LABOREX UGANDA LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

Page 263: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3640 PHARMATHEN LTD STABILANOL

NDA/MAL/HDP/1407 PHARMATHEN S.A BELIFAX

NDA/MAL/HDP/4743 DAFRA PHARMA N.V/S.A MERONIA 1000

NDA/MAL/HDP/4744 DAFRA PHARMA N.V/S.A MERONIA 500

NDA/MAL/HDP/2561 PHARMATHEN LTD LANOMYCIN

NDA/MAL/HDP/2673 PHARMATHEN LTD STRADUMEL

NDA/MAL/HDP/0504 NVS KENYA LTD BANEOCIN POWDER

NDA/MAL/HDP/6708 HEALTHCARE LTD. CLOMINOL TABLETS

NDA/MAL/HDP/6710 HEALTHCARE LTD. DIABIN TABLETS

NDA/MAL/HDP/6719 HEALTHCARE LTD. NAPROX-500

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

SURGIPHARM (U) LIMITED

PHARMEDIC LABORATORIES(PVT) LIMITED

PHARMEDIC LABORATORIES(PVT) LIMITED

PHARMEDIC LABORATORIES(PVT) LIMITED

Page 264: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6727 HEALTHCARE LTD. ZYNOL-300MG TABLET

NDA/MAL/HDP/6730 HEALTHCARE LTD. CEFOTRIM-1000

NDA/MAL/HDP/6680 HEALTHCARE LTD. ATELOR TABLET

NDA/MAL/HDP/8284 HEALTHCARE LTD. CIPLOX-5OO TABLETS

NDA/MAL/HDP/1240 BRICVED LTD CETIRIZINE HYDRCHLORIDE

NDA/MAL/HDP/0812 BRICVED LTD FENPAED

NDA/MAL/HDP/0809 BRICVED LTD PARAPAED

NDA/MAL/HDP/1081 BRICVED LTD ACIDEX

NDA/MAL/HDP/6501 AARTROGYL 200 TABLET

NDA/MAL/HDP/6568 PINNADIP 50 TABLET

PHARMEDIC LABORATORIES(PVT) LIMITED

PHARMEDIC LABORATORIES(PVT) LIMITED

PHARMEDIC LABORATORIES(PVT) LIMITED

PHARMEDIC LABORATORIES(PVT) LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

BOOTS PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

Page 265: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7013 AZITHRAA 500

NDA/MAL/HDP/7014 ACEAAR 100 TABLET

NDA/MAL/HDP/7021 PINNOFEC PLUS

NDA/MAL/HDP/7022 PINNAFLAM PLUS

NDA/MAL/HDP/7091 AARLEFLOX 500 TABLETS

NDA/MAL/HDP/7218 AARTMIN 500

NDA/MAL/HDP/7229 AARCIFLOX 500

NDA/MAL/HDP/7257 PAARPIN TABLET

NDA/MAL/HDP/7421 GESIC ADL 200

NDA/MAL/HDP/8338 ACEAAR P

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

PINNACLE LIFE SCIENCE PVT. LTD.

METRO PHARMACEUTICALS LIMITED

Page 266: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8246 PHARMACIA S.P.A ERIS LTD ALDACTONE

NDA/MAL/HDP/2756 PFIZER LABORATORIES LTD CYTOTEC

NDA/MAL/HDP/1354 PFIZER LABS LIMITED ARTHROTEC

NDA/MAL/HDP/6099 ABACUS PHARMA (A) LTD. HARIPIL-60

NDA/MAL/HDP/6104 ABACUS PHARMA (A) LTD. FUROSEMIDE

NDA/MAL/HDP/6102 ABACUS PHARMA (A) LTD. TELPRESS 80

NDA/MAL/HDP/6103 ABACUS PHARMA (A) LTD. OZACE MD 5

NDA/MAL/HDP/6105 PSYCHTROPICS INDIA LTD AZOPIL 200

NDA/MAL/HDP/7764 ABACUS PHARMA (A) LTD. TELPRESS-H 40/12.5

NDA/MAL/HDP/8104 TELPRESS 40

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 267: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7760 ABACUS PHARMA (A) LTD. OZACE MD 10

NDA/MAL/HDP/0390 TUSSIGON

NDA/MAL/HDP/1471 PT SAMBE FARMA TEMIRAL

NDA/MAL/HDP/0454 PT SANBE FARMA LEVOCIN INFUSION

NDA/MAL/HDP/0389 PT SANBE FARMA SANMOL INFUSION IV

NDA/MAL/HDP/0433 PT SAMBE FARMA PROANES MCT/LCT

NDA/MAL/HDP/1579 PT SANBE FARMA PLASMINEX

NDA/MAL/HDP/2379 PT SANBE FARMA PUMPITOR

NDA/MAL/HDP/4721 PT SAMBE FARMA MEGABAL

NDA/MAL/HDP/0436 PT SANBE FARMA SANBE HEST 130

ABACUS PHARMA (AFRICA) LIMITED

PT NOVELL PHARMACEUTICAL LABORATORIES

ECHO PHARMACY (U) LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

Page 268: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0438 PT SANBE FARMA SANBE HEST 200

NDA/MAL/HDP/4697 PT SAMBE FARMA SANBE CLANEKSI

NDA/MAL/HDP/4658 PT SANBE FARMA MEROSAN 0.5

NDA/MAL/HDP/4749 PT SANBE FARMA MEROSAN

NDA/MAL/HDP/4983 PT SAMBE FARMA PELASTIN

NDA/MAL/HDP/0447 PT SANBE FARMA SANEXON®125

NDA/MAL/HDP/0451 PT SANBE FARMA SANEXON®500

NDA/MAL/HDP/3152 PT SANBE FARMA POLDAN MIG

NDA/MAL/HDP/3118 LUMARTEM

NDA/MAL/HDP/6215 NEORAL 25

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

MEDVIN PHARMA LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

Page 269: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6216 NEORAL 100

NDA/MAL/HDP/2832 ACINO PHARMA AG OLFEN 100 RECTOCAP

NDA/MAL/HDP/6131 ACINO PHARMA AG FERRACIN

NDA/MAL/HDP/4075

NDA/MAL/HDP/6295 LIRAPYN 75MG

NDA/MAL/HDP/1852 VERCEF ORAL SUSPENSION

NDA/MAL/HDP/7715 SIRTURO

NDA/MAL/HDP/6627

NDA/MAL/HDP/6628 STREPSILS REGULAR

NDA/MAL/HDP/4115 REGAL PHARMA (U) LTD PREDILONE

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

RANBAXY LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

CHERICOF COUGH FORMULAR

RANBAXY LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

RANBAXY LABORATORIES LIMITED

STAR PHARMACEUTICALS LTD

JANSSEN-CILAG INTERNATIONAL NV

LABOREX UGANDA LIMITED

RECKITT BENCKISER HEALTHCARE INTERNATIONAL

GITTOES PHARMACEUTICALS LIMITED

STREPSILS HONEY & LEMON

RECKITT BENCKISER HEALTHCARE INTERNATIONAL

GITTOES PHARMACEUTICALS LIMITED

REGAL PHARMACEUTICALS LTD

Page 270: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0016 REGAL PHARMA (U) LTD CODIMEX-CT TABLETS

NDA/MAL/HDP/0178 REGAL PHARMA (U) LTD

NDA/MAL/HDP/2352 REGAL PHARMA (U) LTD COLDCAP DAY TIME

NDA/MAL/HDP/2614 REGAL PHARMA (U) LTD DIALIN

NDA/MAL/HDP/3549 REGAL PHARMA (U) LTD

NDA/MAL/HDP/3556 REGAL PHARMA (U) LTD GRISACTIN-500 TABLETS

NDA/MAL/HDP/2462 REGAL PHARMA (U) LTD HISTALIN SYRUP

NDA/MAL/HDP/6377 EPHICOL CAPSULES

NDA/MAL/HDP/2773 REGAL PHARMA (U) LTD BISPANOL ELIXIR

NDA/MAL/HDP/1223 REGAL PHARMA (U) LTD WHITFIELD'S OINTMENT

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

COLDCAP DAYTIME AND NIGHT TIME CAPSULE

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

TRIMEX PAEDIATRIC COUGH EXPECTORANT

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

Page 271: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1501 REGAL PHARMA (U) LTD CURAQUIN SYRUP

NDA/MAL/HDP/3732 REGAL PHARMA (U) LTD ALBASOL TABLETS 200MG

NDA/MAL/HDP/3757 REGAL PHARMA (U) LTD UNITRIM SUSPENSION

NDA/MAL/HDP/3949 REGAL PHARMA (U) LTD MAGNOMINT SUSPENSION

NDA/MAL/HDP/3987 REGAL PHARMA (U) LTD ROHISOL SYRUP

NDA/MAL/HDP/3990 REGAL PHARMA (U) LTD UNIXIL SYRUP

NDA/MAL/HDP/4114 REGAL PHARMA (U) LTD RINALIN SYRUP

NDA/MAL/HDP/4348 REGAL PHARMA (U) LTD MEDICLOAMP SYRUP

NDA/MAL/HDP/4408 REGAL PHARMA (U) LTD UNISTEN CREAM

NDA/MAL/HDP/4549 REGAL PHARMA (U) LTD UNIXIL 500MG

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

Page 272: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4723 REGAL PHARMA (U) LTD MEGYL SUSPENSION

NDA/MAL/HDP/4725 REGAL PHARMA (U) LTD MEGYL TABLET

NDA/MAL/HDP/4931 REGAL PHARMA (U) LTD FOLIC ACID TABLET

NDA/MAL/HDP/5015 REGAL PHARMA (U) LTD COLDCAP CAPSULES

NDA/MAL/HDP/5017 REGAL PHARMA (U) LTD COLDCAP SYRUP

NDA/MAL/HDP/5032 REGAL PHARMA (U) LTD

NDA/MAL/HDP/5034 REGAL PHARMA (U) LTD MEBENDAZOLE TABLET

NDA/MAL/HDP/5142 REGAL PHARMA (U) LTD INTAMINE CREAM

NDA/MAL/HDP/5180 REGAL PHARMA (U) LTD

NDA/MAL/HDP/5182 REGAL PHARMA (U) LTD ISORYN DROPS (ADULT)

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

DELASED DRY COUGH SYRUP (NON DROWSY)

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

ISORYN DROPS ( PAEDRIATRIC)

REGAL PHARMACEUICALS LTD

Page 273: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5271 REGAL PHARMA (U) LTD ERYTHYL SYRUP

NDA/MAL/HDP/5283 REGAL PHARMA (U) LTD IBUMEX GEL

NDA/MAL/HDP/5288 REGAL PHARMA (U) LTD IBUMEX SUSPENSION

NDA/MAL/HDP/5291 REGAL PHARMA (U) LTD IBUMEX TABLET

NDA/MAL/HDP/5433 REGAL PHARMA (U) LTD COLDCAP NIGHT TIME

NDA/MAL/HDP/1709 REGAL PHARMA (U) LTD LUCIN CREAM

NDA/MAL/HDP/1731 REGAL PHARMA (U) LTD MEDIVEN-S OINTMENT

NDA/MAL/HDP/1790 REGAL PHARMA (U) LTD UNITRIM TABLET

NDA/MAL/HDP/1827 REGAL PHARMA (U) LTD ALBASOL SUSPENSION

NDA/MAL/HDP/1927 REGAL PHARMA (U) LTD INTAPLEX TABLET

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

Page 274: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2025 REGAL PHARMA (U) LTD FERRO-B COMPLEX SYRUP

NDA/MAL/HDP/2368 REGAL PHARMA (U) LTD DERMIDEX CREAM

NDA/MAL/HDP/2513 REGAL PHARMA (U) LTD UNIPEN DRY SYRUP

NDA/MAL/HDP/2516 REGAL PHARMA (U) LTD UNIAMP DRY SUSPENSION

NDA/MAL/HDP/2526 REGAL PHARMA (U) LTD UNISTEN COMBI PACK

NDA/MAL/HDP/2578 REGAL PHARMA (U) LTD MAGNOMINT TABLETS

NDA/MAL/HDP/2596 REGAL PHARMA (U) LTD URISEPTIC

NDA/MAL/HDP/2651 REGAL PHARMA (U) LTD RINAVIT SYRUP

NDA/MAL/HDP/2697 REGAL PHARMA (U) LTD LUCIN OINTMENT

NDA/MAL/HDP/2739 REGAL PHARMA (U) LTD BISPANOL TABLET

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

Page 275: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2760 REGAL PHARMA (U) LTD

NDA/MAL/HDP/2811 REGAL PHARMA (U) LTD SULPHUR OINTMENT

NDA/MAL/HDP/2813 REGAL PHARMA (U) LTD

NDA/MAL/HDP/2914 REGAL PHARMA (U) LTD CHLOROCIDE SYRUP

NDA/MAL/HDP/2917 REGAL PHARMA (U) LTD CETAMOL TABLETS

NDA/MAL/HDP/2959 REGAL PHARMA (U) LTD CETAMOL SYRUP

NDA/MAL/HDP/3263 REGAL PHARMA (U) LTD TRIMEX MUCOLYTIC SYRUP

NDA/MAL/HDP/3288 REGAL PHARMA (U) LTD DELASED SYRUP

NDA/MAL/HDP/3292 REGAL PHARMA (U) LTD

NDA/MAL/HDP/3343 REGAL PHARMA (U) LTD MEDIVEN-CREAM

REGAL PHARMACEUTICALS LTD

DELASED DRY COUGH SYRUP

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

INTACYCLINE SKIN OINTMENT

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

DELASED PAEDIATRIC SYRUP

REGAL PHARMACEUTICALS LTD

Page 276: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3347 REGAL PHARMA (U) LTD UNIPEN TABLETS

NDA/MAL/HDP/3354 REGAL PHARMA (U) LTD MEDIVEN OINTMENT

NDA/MAL/HDP/3426 REGAL PHARMA (U) LTD RUBEM CREAM

NDA/MAL/HDP/3458 REGAL PHARMA (U) LTD UNIXIL

NDA/MAL/HDP/3674 REGAL PHARMA (U) LTD INTAMINE SYRUP

NDA/MAL/HDP/3703 REGAL PHARMA (U) LTD SONATEC

NDA/MAL/HDP/6665 REGAL PHARMA (U) LTD SALBUMOL SYRUP

NDA/MAL/HDP/2580 ABACUS PHARMA LTD REGAL PHARMA (U) LTD HEDON TABLETS

NDA/MAL/HDP/4891 REGAL PHARMA (U) LTD ASPEC TABLET

NDA/MAL/HDP/2452 REGAL PHARMA (U) LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUICALS LTD

REGAL PHARMACEUTICALS LTD

REGAL PHARMACEUTICALS LTD

DELASED CHEST COUGH SYRUP (NON DROWSY)

Page 277: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3077 REGAL PHARMA (U) LTD UNISTEN HC CREAM

NDA/MAL/HDP/1843 USV LIMITED ECORIN-75

NDA/MAL/HDP/1275 REMEDICA LTD NIFELAT 10 F.C TABLETS

NDA/MAL/HDP/4100 REMEDICA LTD NORETHISTERONE

NDA/MAL/HDP/5123 REMEDICA LTD GLYFORMIN 850 TABLETS

NDA/MAL/HDP/1840 REMEDICA LTD OVA-MIT

NDA/MAL/HDP/2312 REMEDICA LTD CLAVOMID 625

NDA/MAL/HDP/2313 REMEDICA LTD CLAVOMID 375

NDA/MAL/HDP/2367 REMEDICA LTD FELEXIN 125

NDA/MAL/HDP/2570 REMEDICA LTD AMOXAPEN 250 CAPSULES

REGAL PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

Page 278: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2805 REMEDICA LTD NIFELAT 20R TABLETS

NDA/MAL/HDP/3304 REMEDICA LTD FELEXIN

NDA/MAL/HDP/3437 REMEDICA LTD REMYCIN 100 CAPSULES

NDA/MAL/HDP/5132 REMEDICA LTD KETROZOL 200 TABLETS

NDA/MAL/HDP/2761 REMEDICA LTD TRIFLUOPERAZINE

NDA/MAL/HDP/2880 REMEDICA LTD CARBIMAZOLE 5

NDA/MAL/HDP/3045 REMEDICA LTD BRAMESTON 2.5

NDA/MAL/HDP/1319 REMEDICA LTD ZESTAVAL 200 F.C TABLETS

NDA/MAL/HDP/4603 REMEDICA LTD HALOXEN - 5

NDA/MAL/HDP/4978 REMEDICA LTD PERAZONE

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

Page 279: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5120 REMEDICA LTD GLYFORMIN 500 TABLETS

NDA/MAL/HDP/5165 REMEDICA LTD

NDA/MAL/HDP/1725 REMEDICA LTD MYCORIL CREAM 1%

NDA/MAL/HDP/1940 REMEDICA LTD CLOXACILLIN CAPSULES

NDA/MAL/HDP/2066 REMEDICA LTD METHOTREXATE

NDA/MAL/HDP/2161 REMEDICA LTD CYCLOVAX CREAM

NDA/MAL/HDP/2203 REMEDICA LTD

NDA/MAL/HDP/2242 REMEDICA LTD CYCLOVAX 200 TABLETS

NDA/MAL/HDP/2359 REMEDICA LTD ASPIREM 75

NDA/MAL/HDP/2361 REMEDICA LTD CLAREM 500

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GRISEOFULVIN 500 TABLETS

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

MYCORIL 100 VAGINAL TABLETS

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

Page 280: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2557 REMEDICA LTD EPSITRON 25 TABLETS

NDA/MAL/HDP/2897 REMEDICA LTD STORILAT

NDA/MAL/HDP/2937 REMEDICA LTD PEN-A-CLOX CAPSULES

NDA/MAL/HDP/2954 REMEDICA LTD VELORIN 100 F.C TABLETS

NDA/MAL/HDP/3578 REMEDICA LTD CINNARON 25

NDA/MAL/HDP/3590 REMEDICA LTD ALFOXAN 500 FC TABLETS

NDA/MAL/HDP/3620 REMEDICA LTD HALOXEN 10 TABLETS

NDA/MAL/HDP/3638 REMEDICA LTD PETILIN 200

NDA/MAL/HDP/3122 GROVIT

NDA/MAL/HDP/0506 HEALTHCARE LTD.

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

GOODMAN INTERNATIONAL LTD

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD

OPTA-ATROPINE EYE DROPS

Page 281: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1549 HEALTHCARE LTD. PREDNICOL EYE DROPS

NDA/MAL/HDP/4768 HEALTHCARE LTD. METHACHLOR EYE DROPS

NDA/MAL/HDP/1714 HEALTHCARE LTD. REMICOL EAR DROPS

NDA/MAL/HDP/2137 HEALTHCARE LTD. SEPRODERM OINTMENT

NDA/MAL/HDP/2280 HEALTHCARE LTD. BETADROP-N

NDA/MAL/HDP/3068 HEALTHCARE LTD. OPTACHLOR EYE DROPS

NDA/MAL/HDP/3221 HEALTHCARE LTD. OPTADEX-N EYE DROPS

NDA/MAL/HDP/6250 HEALTHCARE LTD. ROCIP EYE DROPS

NDA/MAL/HDP/0794 HEALTHCARE LTD. AMYGYDEX

NDA/MAL/HDP/4623 RENE INDUSTRIES LIMITED LOPERAREN

REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN

REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD

REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN

REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN

REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN

REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN

REMINGTON PHARMACEUTICAL INDUS. PVT LTD PAKISTAN

REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD

REMINGTON PHARMACEUTICAL INDUSTRIES PVT LTD

RENE INDUSTRIES LIMITED

Page 282: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1780 RENE INDUSTRIES LTD RENETRIM SUSPENSION

NDA/MAL/HDP/3546 RENE INDUSTRIES LTD RENETRIM D.S

NDA/MAL/HDP/4128 RENE INDUSTRIES LTD VITAREN SYRUP

NDA/MAL/HDP/7101 RENE INDUSTRIES LTD ASTHAREN

NDA/MAL/HDP/7102 RENE INDUSTRIES LTD REPRAZINE

NDA/MAL/HDP/7106 RENE INDUSTRIES LTD REVIVE

NDA/MAL/HDP/7346 RENE INDUSTRIES LTD REZN TABLETS

NDA/MAL/HDP/1524 RENE INDUSTRIES LIMITED AMOXIREN

NDA/MAL/HDP/1523 RENE INDUSTRIES LIMITED AMPIREN

NDA/MAL/HDP/0350 RENE INDUSTRIES LTD CETRIREN

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

Page 283: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0041 RENE INDUSTRIES LTD RECIM

NDA/MAL/HDP/0157 RENE INDUSTRIES LTD RECODIN

NDA/MAL/HDP/0162 RENE INDUSTRIES LTD COSYP-D LINCTUS

NDA/MAL/HDP/0568 RENE INDUSTRIES LTD FLUOXIREN

NDA/MAL/HDP/0166 RENE INDUSTRIES LTD X-PEL

NDA/MAL/HDP/0163 RENE INDUSTRIES LIMITED PHENAREN

NDA/MAL/HDP/0164 RENE INDUSTRIES LIMITED RENPRESS

NDA/MAL/HDP/0161 RENE INDUSTRIES LTD TRAMAREN

NDA/MAL/HDP/1766 RENE INDUSTRIES LTD COLDEASE CAPSULES

NDA/MAL/HDP/1812 RENE INDUSTRIES LTD REQUIN TABLETS

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

Page 284: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1822 RENE INDUSTRIES LTD EPHEDRINE

NDA/MAL/HDP/1825 RENE INDUSTRIES LIMITED COLDEASE SYRUP

NDA/MAL/HDP/1934 RENE INDUSTRIES LTD RENECHLOR SUSPENSION

NDA/MAL/HDP/1942 RENE INDUSTRIES LTD AMCLOREN

NDA/MAL/HDP/2245 RENE INDUSTRIES LTD X-PEL

NDA/MAL/HDP/2408 RENE INDUSTRIES LIMITED RENIRON TONIC

NDA/MAL/HDP/2410 RENE INDUSTRIES LTD DOXYREN

NDA/MAL/HDP/2788 RENE INDUSTRIES LIMITED MULTIVITAMIN TABLETS

NDA/MAL/HDP/3928 RENE INDUSTRIES LTD MALAREN

NDA/MAL/HDP/8662 RENE INDUSTRIES LTD AMOXIREN-DS

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

Page 285: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1605 RENE INDUSTRIES LIMITED ASPIRIN TABLETS

NDA/MAL/HDP/0518 RENE INDUSTRIES LTD CYCLOREN

NDA/MAL/HDP/1454 RENE INDUSTRIES LTD PAINEX

NDA/MAL/HDP/1446 RENE INDUSTRIES LTD VITAMIN B COMPLEX

NDA/MAL/HDP/3747 RENE INDUSTRIES LIMITED ALZOL TABLETS

NDA/MAL/HDP/3888 RENE INDUSTRIES LTD PYRIREN

NDA/MAL/HDP/4352 RENE INDUSTRIES LTD REQUIN SYRUP

NDA/MAL/HDP/4425 RENE INDUSTRIES LTD REQUIN FC

NDA/MAL/HDP/4854 RENE INDUSTRIES LIMITED METROREN FC

NDA/MAL/HDP/4856 RENE INDUSTRIES LIMITED METROREN

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

Page 286: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4858 RENE INDUSTRIES METROREN SUSPENSION

NDA/MAL/HDP/4936 RENE INDUSTRIES LTD COMBIFEN

NDA/MAL/HDP/4939 RENE INDUSTRIES LTD FOLIREN

NDA/MAL/HDP/5107 RENE INDUSTRIES LTD INDOREN CAPSULES

NDA/MAL/HDP/5137 RENE INDUSTRIES LTD KETOREN

NDA/MAL/HDP/5391 RENE INDUSTRIES LTD NITROFURANTOIN

NDA/MAL/HDP/5439 RENE INDUSTRIES LTD RENIRON SYRUP

NDA/MAL/HDP/6065 RENE INDUSTRIES LTD PROXYREN

NDA/MAL/HDP/1850 RENE INDUSTRIES LTD ALZOL TABLETS

NDA/MAL/HDP/1877 RENE INDUSTRIES LTD MINT-O-COOL

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

Page 287: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1914 RENE INDUSTRIES LTD CHLORPHENIRAMINE

NDA/MAL/HDP/2090 RENE INDUSTRIES LTD CIPROREN

NDA/MAL/HDP/2165 RENE INDUSTRIES LTD TRAMAREN

NDA/MAL/HDP/2559 RENE INDUSTRIES LTD ERYTHROREN

NDA/MAL/HDP/2612 RENE INDUSTRIES LIMITED RENIRON

NDA/MAL/HDP/2745 RENE INDUSTRIES LTD RENFORMIN

NDA/MAL/HDP/2797 RENE INDUSTRIES LTD LUMAREN

NDA/MAL/HDP/3262 RENE INDUSTRIES LTD RENEGEL

NDA/MAL/HDP/3318 RENE INDUSTRIES LTD RENETRIM TABLETS

NDA/MAL/HDP/3370 RENE INDUSTRIES LIMITED DERMOREN 500

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

Page 288: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3439 RENE INDUSTRIES LTD RENECHLOR CAPSULE

NDA/MAL/HDP/3614 RENE INDUSTRIES LIMITED ERYTHROREN SUSPENSION

NDA/MAL/HDP/3670 RENE INDUSTRIES LTD TETRAREN CAPSULES

NDA/MAL/HDP/3681 RENE INDUSTRIES LTD RENEDOL

NDA/MAL/HDP/8091 RENE INDUSTRIES LTD RENEGEL SUSPENSION

NDA/MAL/HDP/4172 RENE INDUSTRIES KOF OFF EXPECTORANT

NDA/MAL/HDP/4622 RENE INDUSTRIES LIMITED CLOXAREN

NDA/MAL/HDP/1486 ABACUS PHARMA (A) LTD. AMPIMAX-1

NDA/MAL/HDP/1535 ABACUS PHARMA LTD FORTIWIN-4

NDA/MAL/HDP/2691 ABACUS PHARMA (A) LTD. AMPIMAX-500

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

RENE INDUSTRIES LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 289: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8096 ABACUS PHARMA (A) LTD. BENZALIN

NDA/MAL/HDP/0769 AMPIL-1000

NDA/MAL/HDP/0770 AMPIL-500

NDA/MAL/HDP/0761 BENZILIN

NDA/MAL/HDP/0971 I CARE PHARMA LIMITED VITACARE LTD

NDA/MAL/HDP/0760 STRIDES CEFAX

NDA/MAL/HDP/0822 ABACUS PHARMA LTD CLOXCIN-500

NDA/MAL/HDP/0967 I CARE PHARMA LIMITED VITACARE LTD STREPTOMYCIN

NDA/MAL/HDP/0702 ABACUS PHARMA (A) LTD. SEPTOCIN

NDA/MAL/HDP/6135 ABACUS PHARMA (A) LTD. TRIXONE-S

ABACUS PHARMA (AFRICA) LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BENZYLPENICILLIN INJECTION

SUPER PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 290: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1712 I CARE PHARMA LIMITED VITACARE LTD AMPICILLIN SODIUM

NDA/MAL/HDP/2179 PENICIN

NDA/MAL/HDP/2688 ABACUS PHARMA (A) LTD. AMOXYN-250

NDA/MAL/HDP/2690 ABACUS PHARMA (A) LTD. AMPIMAX-250

NDA/MAL/HDP/3716 I CARE PHARMA LIMITED VITACARE LTD

NDA/MAL/HDP/6673 ABACUS PHARMA LTD TRIXONE-TZ

NDA/MAL/HDP/8253 DICLOFENAC SODIUM

NDA/MAL/HDP/5497 ABACUS PHARMA (A) LTD. EXPEN

NDA/MAL/HDP/4747 RIVA PHARMA FREE ZONE ZITHRORIV

NDA/MAL/HDP/5098 RIVA PHARMA FREE ZONE DIARIV

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CLOXACILLIN SODIUM FOR INJECTION

ABACUS PHARMA (AFRICA) LIMITED

REYOUNG PHARMACEUTICAL CO LTD

ROYAL PHARMA 2011 LIMITED

ABACUS PHARMA (AFRICA) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

Page 291: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1691 ZITHRORIV

NDA/MAL/HDP/8335 RIVA PHARMA FREE ZONE RIVAMOX

NDA/MAL/HDP/6806 F. HOFFMANN- LA ROCHE RECORMON

NDA/MAL/HDP/2168

NDA/MAL/HDP/3113 PANCURONIUM

NDA/MAL/HDP/4140 DIAZEPAM INJECTION

NDA/MAL/HDP/4771 METHYLERGOMETRINE

NDA/MAL/HDP/5163

NDA/MAL/HDP/6171

NDA/MAL/HDP/6172 PHYTOMENADIONE

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

WIDE SPECTRUM ENTERPRISES (U) LIMITED

LABOREX UGANDA LIMITED

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

HYDROCORTISONE INJECTION

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

KETAMINE HYDROCHLORIDE INJECTION

ROTEXMEDICA GMBH ARZNEIMITTELWERK

GITTOES PHARMACEUTICALS LIMITED

SUXAMETHONIUM CHLORIDE

ROTEXMEDICA GMBH ARZNEIMITTELWERK

GITTOES PHARMACEUTICALS LIMITED

Page 292: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6174

NDA/MAL/HDP/1903 DAFRA PHARMA LTD ARTESIANE 100

NDA/MAL/HDP/2480 DAFRA PHARMA LTD ARTESIANE 40

NDA/MAL/HDP/2672 LIDOCAINE

NDA/MAL/HDP/3591 DAFRA PHARMA LTD ARTESIANE 80MG/ML

NDA/MAL/HDP/3597 DAFRA PHARMA LTD ARTESIAN 20MG/ML

NDA/MAL/HDP/0356 BENLE CONSULT LIMITED LEVO DENK 50O

NDA/MAL/HDP/1243 BENLE CONSULT LIMITED LEVO DENK 250

NDA/MAL/HDP/8493 GILEAD SCIENCE INC DESCOVY 200MG/25MG

NDA/MAL/HDP/3763 NORVASC

ROTEXMEDICA GMBH ARZNEIMITTELWERK

GITTOES PHARMACEUTICALS LIMITED

FLUPHENAZINE DECANOATE INJECTION USP 25MG/ML

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

ROTEX MEDICA GBH ARZNEIMITTELI

GITTOES PHARMACEUTICALS LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

DENK PHARMA GMBH & CO KG

DENK PHARMA GMBH & CO KG

MEDICAL ACCESS (UGANDA) LIMITED

PFIZER LABORATORIES PTY LTD

LABOREX UGANDA LIMITED

Page 293: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2597 E DENK OHG BENLE CONSULT LIMITED PARA DENK 250

NDA/MAL/HDP/2648 E DENK OHG BENLE CONSULT LIMITED PARA DENK 125

NDA/MAL/HDP/2428 ERIS LTD BENLE CONSULT LIMITED CLOTRI-DENK 1% CREAM

NDA/MAL/HDP/1636 S.A.ALCON COUVREUR N.V VIGAMOX

NDA/MAL/HDP/6264 ACINO PHARMA AG PARACONICA 1000 MG IV

NDA/MAL/HDP/0868 VARMIKA-500

NDA/MAL/HDP/0869 LARTRM

NDA/MAL/HDP/1141 CALBONE

NDA/MAL/HDP/0308 CEFAX-250

NDA/MAL/HDP/0871 DEXA

KARURI PHARMACEUTICALS LTD.

GOODMAN INTERNATIONAL LTD

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

Page 294: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0551 REDAMOX

NDA/MAL/HDP/0557 REDAMOX 312.5

NDA/MAL/HDP/0305 CEFAX-250 DRY SYRUP

NDA/MAL/HDP/0298 SEFIXI-50 DRY SYRUP

NDA/MAL/HDP/3950 STROM

NDA/MAL/HDP/5409 MINTO GEL

NDA/MAL/HDP/1974 CEFROTIL

NDA/MAL/HDP/3091 ONDI

NDA/MAL/HDP/8247 E-DOL

NDA/MAL/HDP/8279 GENTACIN

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

LINCOLN PHARMACEUTICALS LTD

METRO PHARMACEUTICALS LIMITED

LINCON PHARMCUETICALS LIMITED

METRO PHARMACEUTICALS LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTHCARE PVT LTD

ROYAL PHARMA 2011 LIMITED

Page 295: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4165 ZEFONE INJECTION

NDA/MAL/HDP/3626 ORIPHEX CAPSULES

NDA/MAL/HDP/3651 CADILA HEALTHCARE LTD ORIPHEX SYRUP

NDA/MAL/HDP/0067 ARTEES

NDA/MAL/HDP/6662 DIAPAM

NDA/MAL/HDP/5358 CADILA HEALTHCARE LTD CADISTIN EXPECTORANT

NDA/MAL/HDP/1723 GROVIT MULTIVITAMIN

NDA/MAL/HDP/2604 GROVIT SYRUP

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

CADILA HEALTH CARE LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTHCARE LIMITED

ROYAL PHARMA 2011 LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 296: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0939 ARH

NDA/MAL/HDP/0942 ARH FORTE

NDA/MAL/HDP/0931 ARH JUNIOR

NDA/MAL/HDP/0861 PROZINE

NDA/MAL/HDP/0021 QUINS

NDA/MAL/HDP/0566 CEFROTIL SUSPENSION

NDA/MAL/HDP/6934 SANDOZ GMBH, KUNDL ANASTROZOLE 1 MG

NDA/MAL/HDP/7594 SANDOZ GMBH, KUNDL

NDA/MAL/HDP/1394 SAPIME -1000

NDA/MAL/HDP/1287 SANIX- DS 100

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

LINCOLN PHARMACEUTICALS LIMITED

METRO PHARMACEUTICALS LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SAKAR HEALTH CARE PVT .LTD

ROYAL PHARMA 2011 LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

HYDROCHLOROTHIAZIDE 25MG TABLETS

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

Page 297: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1290 SANIX 400 CAP

NDA/MAL/HDP/1299 SANAXONE PLUS-1000

NDA/MAL/HDP/1393 SANFUR

NDA/MAL/HDP/4287 SANAXONE 1000

NDA/MAL/HDP/4680 SANCEPH DS

NDA/MAL/HDP/2479 SANCEPH-250 CAP

NDA/MAL/HDP/2645 SANZIDIME 1000

NDA/MAL/HDP/6650 INTRIAX-S-1

NDA/MAL/HDP/6796 SANCEPH DS

NDA/MAL/HDP/3606 STRIDES ARCOLAB LTD CELLTRIAXON

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

INDUS LIFE SCIENCES PVT LIMITED

PNR PHARMACEUTICALS LIMITED

SANCE LABORATORIES PVT LTD

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

Page 298: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7228 SANDOZ GMBH, KUNDL

NDA/MAL/HDP/7727 SANDOZ KENYA LTD BIODROXIL

NDA/MAL/HDP/0915 CURAM

NDA/MAL/HDP/1423 CURAM

NDA/MAL/HDP/0640 BIODROXIL

NDA/MAL/HDP/0642 BIODROXIL 125MG/5ML

NDA/MAL/HDP/0651 BIODROXIL

NDA/MAL/HDP/6193 CEFTRIAXONE SANDOZ

NDA/MAL/HDP/6731 PIPTAZO 4.5G

NDA/MAL/HDP/6935 SANDOZ GMBH, KUNDL SIMVASTATIN 40 MG

SURGIPHARM (U) LIMITED

AMOXICILLIN 250MG DISPERSIBLE TABLETS

SURGIPHARM (U) LIMITED

NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES.

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES.

SURGIPHARM (U) LIMITED

SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 299: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7478 SANDOZ GMBH, KUNDL

NDA/MAL/HDP/8140 SANDOZ GMBH, KUNDL FUROSEMIDE

NDA/MAL/HDP/1422 BINOZYT 500MG

NDA/MAL/HDP/6691 AZITHROMYCIN SANDOZ

NDA/MAL/HDP/8282 BINOZYT 500

NDA/MAL/HDP/5301 SANOFI PASTEUR DULTAVAX

NDA/MAL/HDP/3536 SANOFI PASTEUR TETRAXIM

NDA/MAL/HDP/0625 SANOFI PASTEUR VERORAB

NDA/MAL/HDP/1482 SANOFI PASTEUR STAMARIL PASTEUR

NDA/MAL/HDP/4601 SANOFI PASTEUR PENTAXIM VACCINE

SURGIPHARM (U) LIMITED

SIMVASTATIN 20 MG FILM-COATED TABLETS

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES LTD

SURGIPHARM (U) LIMITED

SANDOZ GMBH C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

SANDOZ KENYA C/O NOVARTIS PHARMA SERVICES INC

SURGIPHARM (U) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

Page 300: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4734 SANOFI PASTEUR

NDA/MAL/HDP/5336 SANOFI PASTEUR AVAXIM 160U

NDA/MAL/HDP/5337 SANOFI PASTEUR AVAXIM 80IU PAEDIATRIC

NDA/MAL/HDP/2159 SANOFI PASTEUR VAXIGRIP

NDA/MAL/HDP/2474 SANOFI PASTEUR TYPHIM VI

NDA/MAL/HDP/2978 SANOFI PASTEUR TETAVAX

NDA/MAL/HDP/4730 SANOFI PASTEUR MENACTRA

NDA/MAL/HDP/3058 SANOFI-AVENTIS XATRAL LP 10MG

NDA/MAL/HDP/4874 SANOFI-AVENTIS CLEXANE

NDA/MAL/HDP/4876 SANOFI-AVENTIS CLEXANE

LABOREX UGANDA LIMITED

MENINGOCOCCAL VACCINE A+C

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

Page 301: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4877 SANOFI-AVENTIS CLEXANE

NDA/MAL/HDP/4879 SANOFI-AVENTIS CLEXANE

NDA/MAL/HDP/0257 SANOFI AVENTS FRANCE CORDARONE

NDA/MAL/HDP/3446 SANOFI-AVENTIS CORDARONE

NDA/MAL/HDP/0490 SISONKE ORELOX

NDA/MAL/HDP/2278 ORELOX

NDA/MAL/HDP/3624 ORELOX

NDA/MAL/HDP/0737 SANOFI AVENTIS TAXOTERE 80MG

NDA/MAL/HDP/1025 INSUMAN COMB 30

NDA/MAL/HDP/1217 SANOFI AVENTIS INSUMAN BASAL

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

AVENTIS INTERCONTINENTAL

LABOREX UGANDA LIMITED

AVENTIS INTERCONTINENTAL

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

SANOFI –AVENTIS DEUTSCHLAND

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

Page 302: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4681 SANOFI AVENTIS INSUMAN COMB 30

NDA/MAL/HDP/1277 SANOTI AVENTIS INSUMAN RAPID

NDA/MAL/HDP/7909 SANOFI-AVENTIS KENYA LANTUS

NDA/MAL/HDP/7910 SANOFI-AVENTIS KENYA LANTUS

NDA/MAL/HDP/7911 SANOFI-AVENTIS KENYA LANTUS SOLOSTAR

NDA/MAL/HDP/0739 SANOFI AVENTIS TAXOTERE 20MG

NDA/MAL/HDP/4035 BAYER SCHERING PHARMA YASMIN

NDA/MAL/HDP/5444 MSD (PTY) LIMITED SA AERIUS TABLETS

NDA/MAL/HDP/5265 MSD (PTY) LIMITED SA DIPROSONE OINTMENT

NDA/MAL/HDP/5349 MSD (PTY) LIMITED SA CELESTAMINE TABLETS

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

SURGIPHARM (U) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

Page 303: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3389 BAYER PHARMA AG CLARINASE REPE TABS

NDA/MAL/HDP/3409 BAYER PHARMA AG CLARITINE

NDA/MAL/HDP/5263 MSD (PTY) LIMITED SA DIPROSALIC OINTMENT

NDA/MAL/HDP/5294 MSD (PTY) LIMITED SA ELOCOM OINTMENT

NDA/MAL/HDP/4019 FLUCAMOX 1G

NDA/MAL/HDP/4024 SEDALAC SYRUP

NDA/MAL/HDP/4536 FLUCAMOX

NDA/MAL/HDP/2719 LORASED

NDA/MAL/HDP/2720

NDA/MAL/HDP/0472

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

SEDICO PHARMACEUTICAL CO.

WIDE SPECTRUM ENTERPRISES (U) LIMITED

SEDICO PHARMACEUTICAL CO.

WIDE SPECTRUM ENTERPRISES (U) LIMITED

SEDICO PHARMACEUTICAL CO.

WIDE SPECTRUM ENTERPRISES (U) LIMITED

SEDICO PHARMACEUTICAL CO.

WIDE SPECTRUM ENTERPRISES (U) LIMITED

SEDICO PHARMACEUTICAL CO.

WIDE SPECTRUM ENTERPRISES (U) LIMITED

FLUCAMOX 250MG POWDER FOR ORAL SUSPENSION

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

BCG VACCINE (FREEZE DRIED)

Page 304: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1107

NDA/MAL/HDP/1041 REPOITIN

NDA/MAL/HDP/3818 REPOITIN

NDA/MAL/HDP/4652

NDA/MAL/HDP/4731 MENAFRIVAC

NDA/MAL/HDP/2073 SII MEASLES VACCINE LIVE

NDA/MAL/HDP/2283

NDA/MAL/HDP/2333

NDA/MAL/HDP/2334

NDA/MAL/HDP/2348

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

HEPATITIS B VACCINE(RDNA) (PAEDIATRIC))

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SII TETANUS TOXOID VACCINE

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SII DIPHTHERIA TETANUS PERTUSIS

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SII DIPHTHERIA & TETANUS VAC

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SII MEASLES MUMPS & RUBELLA

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

HEPATITIS B VACCINE(RDNA) ADULT

Page 305: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3203 TETANUS ANTITOXIN

NDA/MAL/HDP/8097 REPOITIN 5000

NDA/MAL/HDP/1534 PARACETAMOL

NDA/MAL/HDP/1991 TETRACYCLINE

NDA/MAL/HDP/3625 AMOXICILLIN

NDA/MAL/HDP/0554 ABACUS PHARMA LTD INDOCAP-25

NDA/MAL/HDP/4840 METRONIDAZOLE

NDA/MAL/HDP/5325 INDOMETACIN

NDA/MAL/HDP/6682 PROCILIN

NDA/MAL/HDP/0765 PHARM ACCESS AFRICA LTD LEVOPLANT

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

SERUM INSTITUTE OF INDIA LTD.

NORVIK ENTERPRISES LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

ABACUS PHARMA (AFRICA) LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY-COTEC PHARMACEUTICALS CO.,LTD

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 306: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3847 ROYAL PHARMA

NDA/MAL/HDP/4031 SALBUTAMOL SYRUP

NDA/MAL/HDP/6055 EURARTESIM

NDA/MAL/HDP/6300 AMOXICILLIN

NDA/MAL/HDP/3835 GLAXOSMITHKLINE LTD HEDEX CAPLETS

NDA/MAL/HDP/3835 GLAXOSMITHKLINE LTD HEDEX CAPLETS

NDA/MAL/HDP/1726 ERIS LTD HAVRIX 720

NDA/MAL/HDP/2992 ERIS LTD HAVRIX1440

NDA/MAL/HDP/0284 GLAXO SMITHLINE LIMITED ERIS LTD CLAVULIN

NDA/MAL/HDP/0614 ERIS LTD CLAVULIN

ROYAL PHARMA 2011 LIMITED

FORTIFIED PROCAINE PENICILLIN

SEDICO PHARMACEUTICAL CO

WIDE SPECTRUM ENTERPRISES (U) LIMITED

SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A

LABOREX UGANDA LIMITED

GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

BETA HEALTHCARE UGANDA LIMITED

BETA HEALTHCARE UGANDA LIMITED

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 307: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3914 GLAXOSMITHKLINE LTD ERIS LTD AUGMENTIN

NDA/MAL/HDP/2256 GLAXOSMITH KLINE LTD ERIS LTD AUGMENTIN 457MG/5ML

NDA/MAL/HDP/2338 ERIS LTD CLAVULIN

NDA/MAL/HDP/2375 GLAXO SMITHLINE LIMITED ERIS LTD CLAVULIN 1G

NDA/MAL/HDP/2378 ERIS LTD AUGMENTIN

NDA/MAL/HDP/2383 ERIS LTD AUGMENTIN

NDA/MAL/HDP/2710 ERIS LTD AUGMENTIN BD

NDA/MAL/HDP/3046 GLAXO SMITHLINE LIMITED ERIS LTD CLAVULIN

NDA/MAL/HDP/3393 ERIS LTD AUGMENTIN 375MG

NDA/MAL/HDP/3404 GLAXO SMITHLINE LIMITED ERIS LTD CLAVULIN

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

Page 308: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3668 ERIS LTD AUGMENTIN BD

NDA/MAL/HDP/3671 ERIS LTD CLAVULIN TABLETS

NDA/MAL/HDP/3907 GLAXOSMITHKLINE LTD ERIS LTD

NDA/MAL/HDP/4941 GLAXO SMITH KLINE LTD ERIS LTD

NDA/MAL/HDP/4859 ERIS LTD FLOXAPEN

NDA/MAL/HDP/7523 BENLE CONSULT LIMITED LEVOFLOX-DENK 5 MG/ML

NDA/MAL/HDP/2706 DUSPATALIN

NDA/MAL/HDP/5151 BETASEC

NDA/MAL/HDP/4107 ABBOTT HEALTHCARE , SAS DUSPATALIN 200 MG

NDA/MAL/HDP/3698 HIPHEN SYRUP

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

ANDREWS LIVER SALT REGULAR

BEECHAMS POWDERS HOT LEMON

GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD

DENK PHARMA GMB H &CO. KG

SOLVAY PHARMACEUTICALS BV

STAR PHARMACEUTICALS LTD

SOLVAY PHARMACEUTICALS BV

STAR PHARMACEUTICALS LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

CADILA HEALTHCARE PVT LTD

ABACUS PHARMA (AFRICA) LIMITED

Page 309: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0312 SPARSH BIO-TECH PVT LTD

NDA/MAL/HDP/3951 SPARSH BIO-TECH PVT LTD SPAMCLOX

NDA/MAL/HDP/4366 SPARSH BIO-TECH PVT LTD CLOXISPA

NDA/MAL/HDP/1879 SPARSH BIO-TECH PVT LTD SPENIV

NDA/MAL/HDP/1880 SPARSH BIO-TECH PVT. LTD SPAMCLOX

NDA/MAL/HDP/1882 SPARSH BIO-TECH PVT LTD SPAMCIL

NDA/MAL/HDP/2414 SPARSH BIO-TECH PVT LTD SPAMCIL

NDA/MAL/HDP/3316 SPARSH BIO-TECH PVT LTD SPAMOX

NDA/MAL/HDP/1302 CADILA HEALTHCARE LTD HIPEN CAPSULES

NDA/MAL/HDP/6092 SPARSH BIO-TECH PVT LTD SPOTCLAV 1000

ABACUS PHARMA (AFRICA) LIMITED

CLOXISPA ORAL SOLUTION 125

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

Page 310: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6093 SPARSH BIO-TECH PVT LTD SPOTCLAV 625

NDA/MAL/HDP/6201 SPARSH BIO-TECH PVT. LTD

NDA/MAL/HDP/6229 SPARSH BIO-TECH PVT LTD

NDA/MAL/HDP/1881 SPARSH BIO-TECH PVT. LTD SPAMOX

NDA/MAL/HDP/6664 SPARSH BIO-TECH PVT LTD SPAMOX 125 KID

NDA/MAL/HDP/6667 SPARSH BIO-TECH PVT LTD SPAMOX 250 DT

NDA/MAL/HDP/3787 SPARSH BIO-TECH PVT LTD SPENIV

NDA/MAL/HDP/4330 SPARSH BIO-TECH PVT. LTD

NDA/MAL/HDP/6094 SPARSH BIO-TECH PVT LTD SPOTCLAV 375

NDA/MAL/HDP/0724 JASSEN-CILAG (PTY) LTD NIZORAL

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

AMOXICILLIN AND FLUCLOXACILLIN CAPSULES 500MG

ABACUS PHARMA (AFRICA) LIMITED

CO-FLUAMPICIL CAPSULES BP 500MG

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

ABACUS PHARMA (AFRICA) LIMITED

FLUCLOXACILLIN CAPSULES

ABACUS PHARMA (AFRICA) LIMITED

LABOREX UGANDA LIMITED

Page 311: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1514 VERMOX

NDA/MAL/HDP/4785 JASSEN-CILAG (PTY) LTD DAKTACORT

NDA/MAL/HDP/4787 JASSEN-CILAG (PTY) LTD DAKTARIN

NDA/MAL/HDP/4788 JASSEN-CILAG (PTY) LTD DAKTARIN ORAL GEL

NDA/MAL/HDP/5175 JASSEN-CILAG (PTY) LTD GYNO-DAKTARIN

NDA/MAL/HDP/5685 VERMOX

NDA/MAL/HDP/1866 JASSEN-CILAG (PTY) LTD NIZORAL

NDA/MAL/HDP/1952 NIZORAL

NDA/MAL/HDP/2252 VERMOX

NDA/MAL/HDP/3693 JASSEN-CILAG (PTY) LTD IMODIUM

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

JOHNSON &JOHNSON (PTY) LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

JOHNSON&JOHNSON PTY LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

LABOREX UGANDA LIMITED

Page 312: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1045 ZIMAX 500

NDA/MAL/HDP/0974 CEF-3

NDA/MAL/HDP/1038 CEF-3

NDA/MAL/HDP/1040 CEF-3 DS

NDA/MAL/HDP/4720 CEFTRON

NDA/MAL/HDP/2735 FORCE

NDA/MAL/HDP/6110 AMBROX

NDA/MAL/HDP/6315 ACE SYRUP, 100ML

NDA/MAL/HDP/1180

NDA/MAL/HDP/2606 PROTAS 40

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE CEPHALOSPORINS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE CEPHALOSPORINS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE CEPHALOSPORINS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE CEPHALOSPORINS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE CEPHALOSPORINS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD.PABNA UNIT

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

ZIF TIMED RELEASED CAPSULES

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

Page 313: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0978 AMBROX 75 SR CAPSULE

NDA/MAL/HDP/0987 ALATROL TABLETS

NDA/MAL/HDP/1002 CIPROCIN T 750

NDA/MAL/HDP/0966 CLOFENAC DT

NDA/MAL/HDP/0983 ANADOL CAPSULES

NDA/MAL/HDP/0806 SQUARE ZINC

NDA/MAL/HDP/6107 SULPREX

NDA/MAL/HDP/7309

NDA/MAL/HDP/1043 FLEXI 100

NDA/MAL/HDP/6106 TREVOX 500

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

BECLOMIN 250 HFA INHALER

SQUARE CEPHALOSPORINS LTD

GAMA PHARMACEUTICALS (U) LIMITED

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

Page 314: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6170 ALACOT 0.1% EYE DROPS

NDA/MAL/HDP/0483 ULGICID TABLETS

NDA/MAL/HDP/0453 AMINOGUARD LIQUID

NDA/MAL/HDP/1132 M-CALZ

NDA/MAL/HDP/0779 VITAFIL Z

NDA/MAL/HDP/0720 JUSDEE 400 DROPS

NDA/MAL/HDP/0449 AMINOGUARD GRANULES

NDA/MAL/HDP/0502 DREZ GARGLE

NDA/MAL/HDP/4331 STEDNAC

NDA/MAL/HDP/4331 STEDNAC

SQUARE PHARMACEUTICALS LTD

GAMA PHARMACEUTICALS (U) LIMITED

FOUNTIL LIFE SCIENCES PVT LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

STEDMAN PHARMACEUTICALS LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

Page 315: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4871 MICOBACT POWDER

NDA/MAL/HDP/4959

NDA/MAL/HDP/4964

NDA/MAL/HDP/4966 CONTUS-650

NDA/MAL/HDP/5330 DREZ-V

NDA/MAL/HDP/6066 DREZ

NDA/MAL/HDP/1851 CAPSIFENAC GEL

NDA/MAL/HDP/1928 NEUTRAFLUX

NDA/MAL/HDP/2230

NDA/MAL/HDP/2411 DREZ

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

CONTUS PAEDIATRIC LINCTUS

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

CONTUS PLUS PAEDIATRIC SUSPENSION

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

NEUTRAFLUX CHERRY FLAVOUR

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

Page 316: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3520 DREZ POWDER

NDA/MAL/HDP/3688

NDA/MAL/HDP/6404 STEDNAC GEL

NDA/MAL/HDP/5323 DREZ

NDA/MAL/HDP/8160

NDA/MAL/HDP/8170

NDA/MAL/HDP/1226 SALBUTAMOL

NDA/MAL/HDP/8186 STRIDES ARCOLAB LTD CELOVAN

NDA/MAL/HDP/0511 STRIDES ARCOLAB LTD

NDA/MAL/HDP/8184 STRIDES ARCOLAB LIMITED TETRACYCLINE

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

NEUTRAFLUX MINT FLAVOUR

STEDMAN PHARMACEUTICALS PVT. LTD

VEERAM HEALTHCARE (U) LIMITED

STEDMAN PHARMACEUTICALS LTD

VEERAM HEALTHCARE (U) LIMITED

FOUNTIL LIFE SCIENCES PVT LTD.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

ULGICID (CHERRY FLAVOUR)

FOUNTIL LIFE SCIENCES PVT LTD.

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

ULGICID (PINEAPPLE FLAVOUR)

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

ROYAL PHARMA 2011 LIMITED

DELMAW ENTERPRISES LIMITED

LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE

ROYAL PHARMA 2011 LIMITED

Page 317: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8185 STRIDES ARCOLAB LTD INDOMETHACIN CAPSULES

NDA/MAL/HDP/4112

NDA/MAL/HDP/2515 SIMFEN 200 TABLETS

NDA/MAL/HDP/1458 STRIDES ARCOLAB LTD CLAVICIN INJECTION

NDA/MAL/HDP/1461 STRIDES ARCOLAB LTD CLAVICIN

NDA/MAL/HDP/2434 STRIDES SHASUN LIMITED . SOLCER

NDA/MAL/HDP/7569 STRIDES SHASUN LIMITED . ARCOMETER

NDA/MAL/HDP/8182 STRIDES ARCOLAB LTD STRICORT

NDA/MAL/HDP/8183 STRIDES ARCOLAB LTD STRICORT-100

NDA/MAL/HDP/8228 STRIDES SHASUN LIMITED .

ROYAL PHARMA 2011 LIMITED

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

ERYTHRONE TABLETS 250MG

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

DELMAW ENTERPRISES LIMITED

ROYAL PHARMA 2011 LIMITED

ROYAL PHARMA 2011 LIMITED

ROYAL PHARMA 2011 LIMITED

VITAMIN B-COMPLEX (BEEKO)

Page 318: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6670 METROSIM-200

NDA/MAL/HDP/4740 ASTRA ZENECA MACNAUGHTON LIMITED MERONEM

NDA/MAL/HDP/4742 ASTRA ZENECA MACNAUGHTON LIMITED MERONEM

NDA/MAL/HDP/1154 BACQURE

NDA/MAL/HDP/1772 GESTID TABLETS

NDA/MAL/HDP/2399 VOLINI

NDA/MAL/HDP/3314 SILVEREX

NDA/MAL/HDP/8480 ERTIVIX 1MG

NDA/MAL/HDP/0349 CLAXY 1.2 G

NDA/MAL/HDP/3945 CEFONE

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED,

ROYAL PHARMA 2011 LIMITED

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LIMITED

STAR PHARMACEUTICALS LTD

SUN PHARMACEUTICAL INDUSTRIES LTD

STAR PHARMACEUTICALS LTD

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

Page 319: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4042 S-CHLOR

NDA/MAL/HDP/3359 ARTI

NDA/MAL/HDP/8120 ABT

NDA/MAL/HDP/8121 SWISSQUINE

NDA/MAL/HDP/8522 DAYPENAM

NDA/MAL/HDP/3906 LEROLE

NDA/MAL/HDP/3392 HEALTHCARE LTD. TRAMACIN POWDER

NDA/MAL/HDP/1361 FALCI CARE

NDA/MAL/HDP/0362 BUPI

NDA/MAL/HDP/0017 HYCORT

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

PLANET PHARMACEUTICALS UGANDA LTD

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PHAMACEAUTICAL PUT LTD

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

Page 320: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0358 STREPTOCIN

NDA/MAL/HDP/0355 BICO VITA

NDA/MAL/HDP/3922 DIAZI

NDA/MAL/HDP/4276 FALCI CARE

NDA/MAL/HDP/4388 TAZOBAK

NDA/MAL/HDP/5591 SWISSCILLIN

NDA/MAL/HDP/6072

NDA/MAL/HDP/6076 FALCI CARE

NDA/MAL/HDP/2324 SWISSCLOXA

NDA/MAL/HDP/6479

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

HYDRALAZINE HYDROCHLORIDE

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT. LTD.

ROYAL PHARMA 2011 LIMITED

TRAMADOL HYDROCHLORIDE INJECTION 100MG/2ML

Page 321: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8127

NDA/MAL/HDP/8216 SEFOTAX

NDA/MAL/HDP/8337 ARTESUNATE 120 MG

NDA/MAL/HDP/8489 T-DOL

NDA/MAL/HDP/8643 ARTESUNATE 60MG

NDA/MAL/HDP/4739 MERO

NDA/MAL/HDP/7536 NETVAICAIN

NDA/MAL/HDP/8119 HALOPERIDOL DECANOATE

NDA/MAL/HDP/8015 D-FEN

NDA/MAL/HDP/2591 HEALTHCARE LTD. VITAGLOBIN SYRUP

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

LIDOCAINE HYDROCHLORIDE

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD 304

ROYAL PHARMA 2011 LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

ROYAL PHARMA 2011 LIMITED

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

PLANET PHARMACEUTICALS UGANDA LTD

PLANET PHARMACEUTICALS UGANDA LTD

SWISS PARENTERALS PVT. LTD.

SHREEJI PHARMACEUTICALS LIMITED

SWISS PARENTERALS PVT LTD

SHREEJI PHARMACEUTICALS LIMITED

SWISS PHAMACEAUTICAL PUT LTD

Page 322: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3330 HEALTHCARE LTD. DEXA-N

NDA/MAL/HDP/6418 KPI HEALTHCARE LIMITED AZOX 250

NDA/MAL/HDP/8336 KPI HEALTHCARE LIMITED LACINE ® 50

NDA/MAL/HDP/8401 KPI HEALTHCARE LIMITED AZOX-500

NDA/MAL/HDP/1310 ZEE PHARMACEUTICALS LTD ZEEMYCIN-300

NDA/MAL/HDP/1315 ZEE PHARMACEUTICALS LTD ZESOZ-20

NDA/MAL/HDP/1282 ZEE PHARMACEUTICALS LTD LOSABERG

NDA/MAL/HDP/1293 ZEE PHARMACEUTICALS LTD ZEEGRA - 100

NDA/MAL/HDP/7681 ZEE PHARMACEUTICALS LTD ZEECEL 200

NDA/MAL/HDP/4286 ZEE PHARMACEUTICALS LTD ZEEGRA-50

SWISS PHAMACEAUTICAL PUT LTD

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

Page 323: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4333 ZEE PHARMACEUTICALS LTD CARVIBERG

NDA/MAL/HDP/4363 ZEE PHARMACEUTICALS LTD ZEPTRIN

NDA/MAL/HDP/4373 ZEE PHARMACEUTICALS LTD AZIBERG

NDA/MAL/HDP/4383 ZEE PHARMACEUTICALS LTD ZEEMYCIN - 150

NDA/MAL/HDP/1206 THE METHOLATUM CO. LTD DEEP RELIEF

NDA/MAL/HDP/4735 MENTHOLATUM MENTHOLATUM BALM

NDA/MAL/HDP/5028 DEEP HEAT SPRAY

NDA/MAL/HDP/5031 DEEP HEAT RUB

NDA/MAL/HDP/5025 DEEP FREEZE COLD GEL

NDA/MAL/HDP/8468 AIVEEN (U) LIMITED THEOMOX-500

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

ZEE PHARMACEUTICALS LIMITED

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

THE MENTHOLATUM COMPANY LTD TWY

HARLEYS UGANDA LIMITED

THE MENTHOLATUM COMPANY LTD

HARLEYS UGANDA LIMITED

THE MENTHOLATUM COMPANY LTD

HARLEYS UGANDA LIMITED

THEON PHARMACEUTICALS LIMITTED

Page 324: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/8496 AIVEEN (U) LIMITED THEOXONE-500MG

NDA/MAL/HDP/7219 AIVEEN (U) LIMITED THEOXONE -1 G

NDA/MAL/HDP/1734 KAMOMINT

NDA/MAL/HDP/8349 TIL HEALTHCARE PVT LTD KPI HEALTHCARE LIMITED ASTYMIN-C DROPS

NDA/MAL/HDP/8351 TIL HEALTHCARE PVT LTD KPI HEALTHCARE LIMITED ASTYMIN SYRUP

NDA/MAL/HDP/8358 TIL HEALTHCARE PVT LTD KPI HEALTHCARE LIMITED ASTYMIN FORTE

NDA/MAL/HDP/1252 SHURIK LTD ZOY

NDA/MAL/HDP/3282 SHURIK LTD KOFF-GO

NDA/MAL/HDP/0415 SHURIK LTD RELEX

NDA/MAL/HDP/1324 SHURIK LTD TOOTH HEAL

THEON PHARMACEUTICALS LIMITTED

THEON PHARMACEUTICALS LTD

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD

KAMPALA PHARMACEUTICAL INDUSTRIES 1996 LIMITED

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

Page 325: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3813 SHURIK LTD ACTIPAR

NDA/MAL/HDP/3892 SHURIK LTD TETRAX

NDA/MAL/HDP/4171 SHURIK LTD TOREX

NDA/MAL/HDP/4726 SHURIK LTD ADB MIN MULTIPOWER

NDA/MAL/HDP/5005 SHURIK LTD COLD GO

NDA/MAL/HDP/5125 SHURIK LTD

NDA/MAL/HDP/5141 SHURIK LTD KETOMAC SHAMPOO

NDA/MAL/HDP/5361 SHURIK LTD CALFIC

NDA/MAL/HDP/1816 SHURIK LTD DRESS UP CREAM

NDA/MAL/HDP/1970 SHURIK LTD CETRAMAC

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMACEUTICALS PVT LIMITED

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

GLYGESIC FORTE RHUMETIC CREAM

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMACEUTICALS PVT LIMITED

Page 326: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2426 SHURIK LTD PROBEX SYRUP

NDA/MAL/HDP/2753 SHURIK LTD PRASIL

NDA/MAL/HDP/0690 SHURIK LTD HEALTHEASE CREAM

NDA/MAL/HDP/0727 SHURIK LTD STOMACH FIT SYRUP

NDA/MAL/HDP/1067 SHURIK LTD IBUPARA

NDA/MAL/HDP/3745 SHURIK LTD WINDERM CREAM

NDA/MAL/HDP/3823 SHURIK LTD

NDA/MAL/HDP/3840 SHURIK LTD TORACTIN TABLETS

NDA/MAL/HDP/5317 MACK BROWN SHURIK LTD

NDA/MAL/HDP/1841 SHURIK LTD FUNGNIL CREAM

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

D-WORM ORAL SUSPENSION

MACK BROWN PHARMECEUTICALS PVT LTD

DR MAC'S COUGH FROMULA

MACK BROWN PHARMECEUTICALS PVT LTD

Page 327: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1912 SHURIK LTD D-WORM

NDA/MAL/HDP/1966 SHURIK LTD PARACIN

NDA/MAL/HDP/2022 SHURIK LTD TORACTIN

NDA/MAL/HDP/2254 SHURIK LTD BURN CUR CREAM

NDA/MAL/HDP/2708 SHURIK LTD HYPER TABLETS

NDA/MAL/HDP/2721 SHURIK LTD PRIMAFEN TABLET

NDA/MAL/HDP/2722 SHURIK LTD NO SORES

NDA/MAL/HDP/2949 SHURIK LTD FUNGNIL V TABLET

NDA/MAL/HDP/1113 SHURIK LTD ALCID-YELLOW

NDA/MAL/HDP/0957 SHURIK LTD LYRED SYRUP

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMACEUTICALS PVT LIMITED

MACK BROWN PHARMACEUTICALS PVT LIMITED

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMACEUTICALS PVT LIMITED

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMACEUTICALS PVT LIMITED

Page 328: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1663 SHURIK LTD ALCID-PINK

NDA/MAL/HDP/3664 SHURIK LTD AZZY

NDA/MAL/HDP/3862 LAMITOR 100

NDA/MAL/HDP/6838 MEMENTOR 10

NDA/MAL/HDP/1652 VALPARIN CHRONO 300

NDA/MAL/HDP/1348 VALPARIN CHRONO 500

NDA/MAL/HDP/3933 TOZAAR-50

NDA/MAL/HDP/3312 TIDOMET FORTE

NDA/MAL/HDP/1588 TOZAAR-H

NDA/MAL/HDP/4150 ANGIOPRIL-25

MACK BROWN PHARMECEUTICALS PVT LTD

MACK BROWN PHARMACEUTICALS PVT LIMITED

TORRENT PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

Page 329: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4845 ANTIDEP

NDA/MAL/HDP/2024 NEXPRO - 40

NDA/MAL/HDP/2577 TOPCEF 200

NDA/MAL/HDP/2971 LEFRA-20 TABLETS

NDA/MAL/HDP/1999 CARBATOL 200

NDA/MAL/HDP/2000 CALCIGARD RETARD

NDA/MAL/HDP/2409 DEPLATT

NDA/MAL/HDP/0788 AIVEEN (U) LIMITED TRIDANTIN

NDA/MAL/HDP/0781 AIVEEN (U) LIMITED TRICOLD

NDA/MAL/HDP/5189 AIVEEN (U) LIMITED HEMOZEBEX

TORRENT PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARMACEUTICALS LIMITED

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARAMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TORRENT PHARMACEUTICALS LTD

KARURI PHARMACEUTICALS LTD.

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

Page 330: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5282 AIVEEN (U) LIMITED DORFEN

NDA/MAL/HDP/1961 AIVEEN (U) LIMITED MUILTIZEBEX

NDA/MAL/HDP/0783 AIVEEN (U) LIMITED CYPOLIVE

NDA/MAL/HDP/1162 AIVEEN (U) LIMITED WINKLOT

NDA/MAL/HDP/0786 AIVEEN (U) LIMITED DERMA 1

NDA/MAL/HDP/1164 AIVEEN (U) LIMITED PIROXICAM

NDA/MAL/HDP/1165 AIVEEN (U) LIMITED EXBRO

NDA/MAL/HDP/1158 AIVEEN (U) LIMITED TRAMADOL

NDA/MAL/HDP/3645 AIVEEN (U) LIMITED NEUROBEX

NDA/MAL/HDP/3305 SPASMOTROY

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TRIVENI FORMULATIONS LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

Page 331: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3381

NDA/MAL/HDP/1000 TROYCURIUM

NDA/MAL/HDP/0870 TROY-K

NDA/MAL/HDP/5473 TROYPOFOL

NDA/MAL/HDP/0056 DYNAPAR QPS

NDA/MAL/HDP/0755 T- DOL

NDA/MAL/HDP/0726 T DOL RAPID

NDA/MAL/HDP/0578 XYKAA RAPID

NDA/MAL/HDP/5171 KETAMAX-50

NDA/MAL/HDP/7351 TRYFIX CV DS

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TROIKAA PHARMACEUTICALS LTD

ABACUS PHARMA (AFRICA) LIMITED

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

Page 332: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7366 TRYFIX

NDA/MAL/HDP/7367 TRYFIX 100 DS

NDA/MAL/HDP/7379 TRYDROX 250

NDA/MAL/HDP/7380 TRYDROX DS

NDA/MAL/HDP/7385 TRYOXIM DS

NDA/MAL/HDP/7386 TRYLEXIN 125 DS

NDA/MAL/HDP/7388 TRYFIX CV 200

NDA/MAL/HDP/8497 TRYOXIM 500

NDA/MAL/HDP/7369 XOMOX CV DS

NDA/MAL/HDP/7370 XOMOX CV 625

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

Page 333: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/7376 XOMOX CV 375

NDA/MAL/HDP/7377 XOMOX DS

NDA/MAL/HDP/1642 EUCHLOR-1000

NDA/MAL/HDP/4181 UMEDICA LABS PVT LTD USTREP

NDA/MAL/HDP/5166

NDA/MAL/HDP/5525 UMEDICA LABS PVT LTD RILIF-SR

NDA/MAL/HDP/6038 FIXDEP-180

NDA/MAL/HDP/1765 RILIF PLUS

NDA/MAL/HDP/2489 UMETAC-150

NDA/MAL/HDP/2798 UMEDICA LABS PVT LTD OMEGARD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD

SWASTIK PHARMACEUTICAL LTD

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

KETAMINE HYDROCHLORIDE

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

GITTOES PHARMACEUTICALS LIMITED

Page 334: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3309 CLOTRIMAZOLE PESSARIES

NDA/MAL/HDP/4074 UMICORT-100

NDA/MAL/HDP/6133 RILIF-100

NDA/MAL/HDP/2461 UMERAN SR - 100

NDA/MAL/HDP/6492

NDA/MAL/HDP/6632 CIPROFLOXACIN

NDA/MAL/HDP/6634 FIXDEP -120

NDA/MAL/HDP/1584 UNI MEDICO LAB UCLOX

NDA/MAL/HDP/3825 UNI MEDICO LAB UMOXIL 250

NDA/MAL/HDP/2238 UNI MEDICO LAB UMOCLOX

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT. LTD

GITTOES PHARMACEUTICALS LIMITED

LIDOCAINE INJECTION BP 2%W/V

UMEDICA LABORATORIES PVT. LTD

GITTOES PHARMACEUTICALS LIMITED

UMEDICA LABORATORIES PVT. LTD

GITTOES PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

Page 335: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3244 UNI MEDICO LAB UMICILLIN

NDA/MAL/HDP/3595 UNI MEDICO LAB UMOXIL 125

NDA/MAL/HDP/7475 UNI MEDICO LAB UMOCLOX 500

NDA/MAL/HDP/0003 UNI MEDICO LAB UMOXIL CLAV 625

NDA/MAL/HDP/0764 CORVADIL 5

NDA/MAL/HDP/3733 DOMADOL

NDA/MAL/HDP/3767 AMPOXIN 500

NDA/MAL/HDP/3777 AMPOXIN 500

NDA/MAL/HDP/5489 CORBIS-5

NDA/MAL/HDP/2067 ZYNCET

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

SHREEJI PHARMACEUTICALS LIMITED

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

Page 336: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2068 DOMADOL

NDA/MAL/HDP/2790 TG-TOR 20

NDA/MAL/HDP/2792 TG-TOR 10

NDA/MAL/HDP/3334 MYCLAV 375

NDA/MAL/HDP/3373 MYCLAV 625

NDA/MAL/HDP/3547 CORBIS-10

NDA/MAL/HDP/0372 LEZYNCET

NDA/MAL/HDP/5038 M-CAM TABLETS

NDA/MAL/HDP/1977 LOSA-H

NDA/MAL/HDP/3444 CORVADIL 10

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LIMITED√

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LIMITED√

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

Page 337: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1641 UNIENZYME C MPS

NDA/MAL/HDP/1990 TAGERA FORTE

NDA/MAL/HDP/3872 ZYNCET SYRUP

NDA/MAL/HDP/1546 LANPRO

NDA/MAL/HDP/3989 CELIB 200MG

NDA/MAL/HDP/4126 CELIB 100MG

NDA/MAL/HDP/1893 TRIKA 0.25 TABLETS

NDA/MAL/HDP/2404 LOSAR 50

NDA/MAL/HDP/0143 UNIMED INDIA METAPLUS (U) LIMITED SPECTRIM SUSPENSION

NDA/MAL/HDP/3890 UNIMED INDIA METAPLUS (U) LIMITED PARACETAMOL SYRUP

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

UNICHEM LABORATORIES LTD

EUROPA HEALTHCARE (U) LTD

UNICHEM LABORATORIES LIMITED√

EUROPA HEALTHCARE (U) LTD

Page 338: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4849 UNI-MED INDIA METAPLUS (U) LIMITED

NDA/MAL/HDP/5008 UNIMED METAPLUS (U) LIMITED COLDAFEX

NDA/MAL/HDP/5011 UNIMED METAPLUS (U) LIMITED COLDAFEX TABLETS

NDA/MAL/HDP/8281 UNIMED INDIA METAPLUS (U) LIMITED

NDA/MAL/HDP/2776 TATA UGANDA LIMITED TENSIMIN-100

NDA/MAL/HDP/2969 TATA UGANDA LIMITED TENSIMIN-50

NDA/MAL/HDP/3869 TATA UGANDA LIMITED RANTAB INJECTION

NDA/MAL/HDP/4826 TATA UGANDA LIMITED METROGYL DENTA GEL

NDA/MAL/HDP/6064 TATA UGANDA LIMITED JOCET 10

NDA/MAL/HDP/1953 TATA UGANDA LIMITED RANTAB-150

METRONIDAZOLE ORAL SUSPENSION

CO-TRIMOXAZOLE TABLET BP

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LTD

UNIQUE PHARMACEUTICAL LABORATORIES

UNIQUE PHARMACEUTICALS LTD

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

Page 339: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4828 TATA UGANDA LIMITED METROGYL GEL

NDA/MAL/HDP/4830 TATA UGANDA LIMITED METROGYL INJECTION

NDA/MAL/HDP/6214 TATA UGANDA LIMITED VIXIB

NDA/MAL/HDP/8165 TATA UGANDA LIMITED CUFO BLACK CURRANT

NDA/MAL/HDP/8166 TATA UGANDA LIMITED CUFO ORANGE

NDA/MAL/HDP/8285 TATA (U) LTD TATA UGANDA LIMITED

NDA/MAL/HDP/4956 TATA UGANDA LIMITED CONTRAPAQUE 30

NDA/MAL/HDP/4999 TATA UGANDA LIMITED PAMIDOL*370

NDA/MAL/HDP/5326 TATA UGANDA LIMITED ECODAX G CREAM

NDA/MAL/HDP/2892 TATA UGANDA LIMITED NICARDIA-20 TABLETS

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

CUFO LOZENGES(HONEY LEMON)

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICAL LABORATORIES

UNIQUE PHARMACEUTICAL LABORATORIES

UNIQUE PHARMACEUTICAL LABORATORIES

Page 340: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4832 TATA UGANDA LIMITED METROGYL SUSPENSION

NDA/MAL/HDP/3859 TATA UGANDA LIMITED IFIMOL

NDA/MAL/HDP/6767 ADCOCK INGRAM LIMITED MEDI-KEEL A

NDA/MAL/HDP/6768 ADCOCK INGRAM LIMITED

NDA/MAL/HDP/6769 ADCOCK INGRAM LIMITED

NDA/MAL/HDP/7689 TATA UGANDA LIMITED CUFO LOZENGES(LEMON)

NDA/MAL/HDP/5235 TATA UGANDA LIMITED

NDA/MAL/HDP/4558 TATA UGANDA LIMITED IFICIPRO 500

NDA/MAL/HDP/5121 TATA UGANDA LIMITED DICLORAN GEL

NDA/MAL/HDP/5127 TATA UGANDA LIMITED DICLORAN INJECTION

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICAL LABORATORIES

UGANDA HEALTH MARKETING GROUP LIMITED

UGANDA HEALTH MARKETING GROUP LIMITED

MEDI-KEEL A BLACKCURRANT

UGANDA HEALTH MARKETING GROUP LIMITED

MEDI-KEEL A HONEY & LEMON

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

DICLORAN DELAYED-RELEASE TABLETS

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

UNIQUE PHARMACEUTICALS LABORATORIES

Page 341: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/5130 TATA UGANDA LIMITED DICLORAN MS GEL

NDA/MAL/HDP/2366 TATA UGANDA LIMITED IFICIPRO INJECTION

NDA/MAL/HDP/1072 CO-ANGINET 80/12.5MG

NDA/MAL/HDP/0560 GLIMERYL 1

NDA/MAL/HDP/0548 UNICAST

NDA/MAL/HDP/1485 DICLOFEN 25

NDA/MAL/HDP/1048 EXOFEN 120MG

NDA/MAL/HDP/1047 EXOFEN 180MG

NDA/MAL/HDP/0543 GLIMERYL 2

NDA/MAL/HDP/1076 UNICAST 4MG

UNIQUE PHARMACEUTICALS LTD

UNIQUE PHARMACEUTICALS LTD

UNITED PHARMACEUTICAL MANUFACTURING CO. LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING CO. LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING CO. LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 342: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1051 EPIVAL 300MG

NDA/MAL/HDP/1044 ANGINET 80MG

NDA/MAL/HDP/1071 CO-ANGINET 160/25MG

NDA/MAL/HDP/4354 RUXID 300

NDA/MAL/HDP/5468 EPIVAL TABLETS

NDA/MAL/HDP/6184 ATOXIA 60MG

NDA/MAL/HDP/6186

NDA/MAL/HDP/2027 CO-ANGINET 160/12.5MG

NDA/MAL/HDP/2232 UNICAST

NDA/MAL/HDP/6235 ANGINET 160MG

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING CO. LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING CO. LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

ATOXIA 90MG F.C. TABLETS

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING CO. LTD

UNITED HEALTHCARE DISTRIBUTORS LTD

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LIMITED

UNITED HEALTHCARE DISTRIBUTORS LTD

Page 343: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4127 SANOFI AVENTS FRANCE EPILIM

NDA/MAL/HDP/4550 SANOFI AVENTS FRANCE RHINATHIOL 2%

NDA/MAL/HDP/4635 SANOFI-AVENTIS RHINATHIOL 5%

NDA/MAL/HDP/1391 UNIVIR 5%

NDA/MAL/HDP/1195 ALTRINE

NDA/MAL/HDP/0288 DUXCOSPAN

NDA/MAL/HDP/0243 LAMOZID

NDA/MAL/HDP/1389 NELSTAT

NDA/MAL/HDP/1655 UNIGENTYL

NDA/MAL/HDP/0365 SULFRAN- DS

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

LABOREX UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

Page 344: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3151

NDA/MAL/HDP/3427 SULFRAN

NDA/MAL/HDP/1149 NEUROBA

NDA/MAL/HDP/1196 ACNESOL

NDA/MAL/HDP/1918 UNIVIR

NDA/MAL/HDP/1062 VENUS REMEDIES LTD VANCONEX-CP

NDA/MAL/HDP/1460 VENUS REMEDIES LIMITED PARIN E

NDA/MAL/HDP/1064 VENUS REMEDIES LTD OXOL

NDA/MAL/HDP/2915 VENUS REMIDIES LTD TREXOL

NDA/MAL/HDP/3462 VENUS REMIDIES LTD PLATOL

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

CLOTRINE 100 MG PESSARIES

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

UNIVERSAL CORPORATION LTD

DELMAW ENTERPRISES LIMITED

UNIVERSAL CORPORATION LTD

DELMAW ENTERPRISES LIMITED

UNIVERSAL CORPORATION LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

Page 345: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3467 VENUS REMEDIES LTD RONEM

NDA/MAL/HDP/3471 VENUS REMEDIES LTD PAXOL

NDA/MAL/HDP/3573 VENUS REMEDIES LIMITED PARIN-E

NDA/MAL/HDP/1194 VENUS REMEDIES LTD PISA

NDA/MAL/HDP/4798 VENUS REMIDIES LTD CITABOL

NDA/MAL/HDP/5162 VENUS REMIDIES LTD IRINOL

NDA/MAL/HDP/3009 VENUS REMEDIES LIMITED SULBACTOMAX 1.5G

NDA/MAL/HDP/3110 VENUS REMEDIES LIMITED ZYDOTUM

NDA/MAL/HDP/3254 VENUS REMEDIES LIMITED ROBOL

NDA/MAL/HDP/3475 VENUS REMIDIES LTD RONEM

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

Page 346: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3541 VENUS REMEDIES LTD CARBOL

NDA/MAL/HDP/3550 VENUS REMEDIES LIMITED DOXOL

NDA/MAL/HDP/3586 VENUS REMEDIES LIMITED DOXOL

NDA/MAL/HDP/3348 VENUS REMEDIES LTD PIMCEF

NDA/MAL/HDP/3449 VENUS REMEDIES LIMITED IMMUNOX

NDA/MAL/HDP/3452 VENUS REMEDIES LTD PAXOL

NDA/MAL/HDP/3552 VENUS REMIDIES LTD CARBOL

NDA/MAL/HDP/4539 VENUS REMEDIES LTD CRISTOL

NDA/MAL/HDP/5117 VENUS REMEDIES LIMITED LASTINEM

NDA/MAL/HDP/0072 VHB MEDI SCIENCES LTD RENE PHARMACY LTD AMTERICIN

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

AARON PHARMACEUTICALS LTD

HARLEYS UGANDA LIMITED

Page 347: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/1403 VHB MEDI SCIENCES LTD RENE PHARMACY LTD DOMAXIN-RD 10MG

NDA/MAL/HDP/4782 VHB MEDI SCIENCES LTD RENE PHARMACY LTD CYBIN PF

NDA/MAL/HDP/5047 VHB MEDI SCIENCES LTD RENE PHARMACY LTD MAXINEM 500MG

NDA/MAL/HDP/5048 VHB MEDI SCIENCES LTD RENE PHARMACY LTD MAXINEM 1G

NDA/MAL/HDP/5178 VHB MEDI SCIENCES LTD RENE PHARMACY LTD CARBOTEEN

NDA/MAL/HDP/5296 VHB MEDI SCIENCES LTD RENE PHARMACY LTD DOMAXIN-RD

NDA/MAL/HDP/5345 VHB MEDI SCIENCES LTD RENE PHARMACY LTD CEFTRIMAX

NDA/MAL/HDP/2123 VHB MEDI SCIENCES LTD RENE PHARMACY LTD PLATFIRST

NDA/MAL/HDP/2135 VHB MEDI SCIENCES LTD RENE PHARMACY LTD SOLITAX

NDA/MAL/HDP/2888 VHB MEDI SCIENCES LTD RENE PHARMACY LTD SUCCICORT

Page 348: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3008 VHB MEDI SCIENCES LTD RENE PHARMACY LTD BLEOSOL

NDA/MAL/HDP/3150 VHB MEDI SCIENCES LTD RENE PHARMACY LTD MTX-VHB

NDA/MAL/HDP/0914 OSTEOTIDE

NDA/MAL/HDP/0911 HEALACE

NDA/MAL/HDP/0895 HYORTH

NDA/MAL/HDP/0897 DEBRIDACE

NDA/MAL/HDP/0906 IONSIL

NDA/MAL/HDP/0908 HYOPT PLUS

NDA/MAL/HDP/3971 VIRIAXONE-SL

NDA/MAL/HDP/1469 VOGEN LABORATORIES LTD DURAMOX 125

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

VIRCHOW HEALTHCARE PVT LTD

SURGIPHARM (U) LIMITED

BUFFALO HEALTH CARE LTD

Page 349: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2224 VOGEN LABORATORIES LTD DURAMOX 500

NDA/MAL/HDP/5386 WIN-MEDICARE LTD UDIHEP TABLETS

NDA/MAL/HDP/2475 WIN-MEDICURE LTD URGENDOL INJECTION

NDA/MAL/HDP/3294 WIN-MEDICARE LTD URGENDOL CAPSULES

NDA/MAL/HDP/3598 WIN-MEDICARE LTD MYOSPAZ

NDA/MAL/HDP/5112 WIN-MEDICARE PVT LTD DICLOMOL SR TABLETS

NDA/MAL/HDP/2478 WIN-MEDICARE PVT LTD DICLOMOL PLUS

NDA/MAL/HDP/4707 WIN-MEDICARE PVT LTD DICLOMOL INJECTION

NDA/MAL/HDP/1898 WIN-MEDICARE LTD ZAPACID - 30

NDA/MAL/HDP/1946 WIN-MEDICARE LTD SOLUDOL TABLETS

BUFFALO HEALTH CARE LTD

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

Page 350: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/2770 WIN-MEDICARE PVT LTD RELISURE

NDA/MAL/HDP/3012 WIN-MEDICARE PVT LTD DICLOMOL TABLETS

NDA/MAL/HDP/1516 WIN-MEDICARE LTD URGENDOL P

NDA/MAL/HDP/1585 WIN-MEDICARE PVT LTD UDIHEP FORTE

NDA/MAL/HDP/1826 WIN-MEDICARE LTD LOGICAN-200

NDA/MAL/HDP/2226 WIN-MEDICARE PVT LTD HEPA-MERZ

NDA/MAL/HDP/2477 WIN-MEDICARE LTD LOGICAN-150

NDA/MAL/HDP/2738 WIN-MEDICARE LTD HEPA-MERZ INFUSION

NDA/MAL/HDP/3346 WOCKHARDT LTD ZEDEX

NDA/MAL/HDP/1495 WOCKHARDT LTD PELOX-400

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

SURGIPHARM (U) LIMITED

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

Page 351: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3843 WOCKHARDT LTD AZIWOK

NDA/MAL/HDP/3848 WOCKHARDT LTD AZIWOK

NDA/MAL/HDP/2056 WOCKHARDT LTD BRO-ZEDEX

NDA/MAL/HDP/0719 WOCKHARDT LTD WEPOX 4000

NDA/MAL/HDP/1506 WOCKHARDT LTD WEPOX 2000

NDA/MAL/HDP/2237 WOCKHARDT LTD TATA UGANDA LIMITED WOSULIN-30/70

NDA/MAL/HDP/2249 WOCKHARDT LTD TATA UGANDA LIMITED WOSULIN-R

NDA/MAL/HDP/8477 WOCKHARDT LTD TATA UGANDA LIMITED GLARITUS 100IU/ML

NDA/MAL/HDP/2506 WOCKHARDT LTD NADOXIN

NDA/MAL/HDP/2235 WOCKHARDT LTD TATA UGANDA LIMITED WOSULIN-N

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

STAR PHARMACEUTICALS LTD

Page 352: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/0142 PFIZER LAB LTD PREVENAR 13

NDA/MAL/HDP/3734 XEPA-SOUL PATTINSON ZARICORT CREAM

NDA/MAL/HDP/5010 ZARIN CREAM

NDA/MAL/HDP/5076 DEXTRACIN EYE DROPS

NDA/MAL/HDP/5338 HYDROSIL TABLETS

NDA/MAL/HDP/2458 PRISTINEX 2% CREAM

NDA/MAL/HDP/4906 AVORAX TABLETS

NDA/MAL/HDP/4944 BENA EXPECTORANT

NDA/MAL/HDP/2099

NDA/MAL/HDP/2195 EUDERM CREAM

LABOREX UGANDA LIMITED

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

HYDROCORTISONE 1% CREAM

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

Page 353: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3429 XEPA-SOUL PATTINSON EZEDE

NDA/MAL/HDP/1707 FEBRICOL TABLETS

NDA/MAL/HDP/0352 HARLEYS UGANDA LIMITED ANLODIN TABLET 5MG

NDA/MAL/HDP/1159 VOREN

NDA/MAL/HDP/1157 TRETINON

NDA/MAL/HDP/8499 SOLOCEF 1000 MG

NDA/MAL/HDP/6676 CASPRIN

NDA/MAL/HDP/0316 OFLOXACIN-UF

NDA/MAL/HDP/4665 YURIA PHARM LTD ORNIGIL

NDA/MAL/HDP/0565 YURIA PHARM LTD AMINOCAPROIC ACID-UF

DELMAW ENTERPRISES LIMITED

XEPA SOUL PATTISON (M) SDN BHD

DELMAW ENTERPRISES LIMITED

HARLEYS UGANDA LIMITED

Y.S.P INDUSTRIES (M) SDN BHD

ROYAL PHARMA 2011 LIMITED

Y.S.P INDUSTRIES (M) SDN BHD

ROYAL PHARMA 2011 LIMITED

YELURI FORMULATIONS PVT LTD

GITTOES PHARMACEUTICALS LIMITED

YSP INDUSTRIES(M) SDN BHD

ROYAL PHARMA 2011 LIMITED

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA PHARM EAST AFRICA LIMITED

YURIA PHARM EAST AFRICA LIMITED

Page 354: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/4641 RHEOSORBILACT

NDA/MAL/HDP/4646 YURIA PHARM LTD LEFLOCIN

NDA/MAL/HDP/1938 INFULGAN

NDA/MAL/HDP/0317 CIPROFLOXACIN-UF

NDA/MAL/HDP/0310 LATREN

NDA/MAL/HDP/4655 DECASAN

NDA/MAL/HDP/4661 FLUCONAZOLE-UF

NDA/MAL/HDP/5177 YURIA PHARM LTD ISONIAZID

NDA/MAL/HDP/7384 YURIA PHARM LTD TIVORTIN

NDA/MAL/HDP/4761 ADVIFEN

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA PHARM EAST AFRICA LIMITED

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA-PHARM EAST AFRICA LTD

YURIA PHARM EAST AFRICA LIMITED

YURIA PHARM EAST AFRICA LIMITED

YURIA PHARM EAST AFRICA LIMITED

ZAHRAVI PHARMACEUTICAL COMPANY

UNEED GLOBAL GROUP LIMITED

Page 355: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/6043 ZEMILAST

NDA/MAL/HDP/3954 WOCKHARDT LTD

NDA/MAL/HDP/5304 DUO-COTECXIN

NDA/MAL/HDP/2743 DUO-COTECXIN

NDA/MAL/HDP/3199 MERCK SHARP & DOHME BV ISENTRESS

NDA/MAL/HDP/5001 ASTRA PHARMA (U) LIMITED GENTAMICIN INJECTION

NDA/MAL/HDP/5328 ASTRA PHARMA (UK) LTD

NDA/MAL/HDP/1678 ASTRA PHARMA (U) LIMITED

NDA/MAL/HDP/1905 ASTRA PHARMA (U) LIMITED OXYTOCIN INJECTION

NDA/MAL/HDP/2512 ASTRA PHARMA (U) LIMITED

BHARAT SERUMS AND VACCINES LIMITED,

GITTOES PHARMACEUTICALS LIMITED

STAR PHARMACEUTICALS LTD

POWERCEF 1GM INJECTION

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

BEIJING HOLLEY COTEC PHARMA CHINA

SUPER PHARMACEUTICALS LIMITED

PHILLIPS PHARMACEUTICALS (UGANDA) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

INDOMETACIN 25MG CAPSULES BP

ASTRA PHARMA (U) LIMITED

HYDROCORTISONE SODIUM SUCCINATE

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

DICLOFENAC SODIUM INJECTABLE SOLUTION

Page 356: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3185 ASTRA PHARMA (U) LIMITED

NDA/MAL/HDP/3564 ASTRA PHARMA (U) LIMITED ATROPINE INJECTION

NDA/MAL/HDP/3577 ASTRA PHARMA (U) LTD METOCLOPRAMIDE

NDA/MAL/HDP/3599 ASTRA PHARMA LTD

NDA/MAL/HDP/3673 ASTRA PHARMA (U) LIMITED PROMETHAZINE

NDA/MAL/HDP/2726 ASTRA PHARMA (U) LIMITED QUININE INJECTION

NDA/MAL/HDP/4340 ASTRA PHARMA (U) LTD VITAMIN B COMPLEX

NDA/MAL/HDP/2274 ASTRA PHARMA (UK) LTD

NDA/MAL/HDP/2724

NDA/MAL/HDP/2926 ASTRA PHARMA (UK) LTD

ASTRA PHARMA (U) LIMITED

AMINOPHYLLINE INJECTION

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

CHLORPROMAZINE INJECTION

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

ASTRA PHARMA (U) LIMITED

PARACETAMOL TABLETS 500MG

UNEED GLOBAL GROUP LIMITED

ASTRA PHARMA (U) LIMITED

CHLORAMPHENICOL 250MG CAPSULES BP

ASTRA PHARMA (U) LIMITED

TETRACYCLINE 250MG CAPSULES BP

Page 357: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NDA/MAL/HDP/3017 ASTRA PHARMA (U) LIMITED LIDOCAINE INJECTION

NDA/MAL/HDP/3018 DICLOFENAC SODIUM

ASTRA PHARMA (U) LIMITED

ROYAL PHARMA 2011 LIMITED

SINO AFRICA MEDICINES & HEALTH LTD

Page 358: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GENERIC NAMES STRENGTHS MANUFACTURER NAMES

INDIA

METRONIDAZOLE 0.5%W/V INDIA

SODIUM CHLORIDE 0.9%W/V INDIA

GLUCOSE ANHYDROUS 5%W/V INDIA

MECOBALAMIN + PREGABALIN 750MCG + 75MG INDIA

TRAMADOL HYDROCHLORIDE 50MG INDIA

PANTOPRAZOLE+DOMPERIDONE 20MG + 10MG INDIA

LUMEFANTRINE + ARTEMETHER 480 MG + 80 MG INDIA

LEVONORGESTREL 1.5MG INDIA

METHYLCOBALAMIN 500MCG/ML INDIA

PRODUCT ORIGIN

SODIUM LACTATE SOLUTION +SODIUM CHLORIDE + CALCIUM CHLORIDE + POTASSIUM CHLORIDE

0.533 GM +0.600 GM + 0.027G+ 0.040 GM/100ML

ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA

ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA

ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA

ABARIS HEALTHCARE PVT. LTD--PLOT NO: 1407-1411 VILLAGE: RAJPUR TALUKA: KADI, DIST.: MEHSANA 382 740, GUJARAT INDIA

ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101

ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101

ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101

ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101

ACME FORMULATION PVT LTD.- ROPAR ROAD NALAGARH DIST SOLAN (H.P) -174 101

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT III, PLOT NO 2,3,4 &5, SECTOR 6-B, IIE, SIDCUL RANIPUR HARIDWAR-249403 UTTARAKHAND INDIA

Page 359: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFIXIME TRIHYDRATE 100MG/5ML INDIA

CLOTRIMAZOLE 100MG INDIA

80MG+ 400MG INDIA

PARACETAMOL 500MG INDIA

800MG + 160MG INDIA

5MG+25MG GERMANY

ARTESUNATE 60MG INDIA

LINEZOLID 600MG INDIA

GLIMEPIRIDE 2MG GERMANY

GLIMEPIRIDE 3MG GERMANY

ASSOCIATED BIOTECH-VILLAGE : KISHANPURA, GURU MAJRA, BADDI, DISTT. SOLAN,INDIA.

ASTRA LIFE CARE (INDIA) PVT-PLOT 57 ROJADA382220, BAVLA AHMEDABAD INDIA

TRIMETHOPRIM + SULPHAMETHOXAZOLE

BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGARUDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA

BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGARUDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA

SULFAMETHOXAZOLE + TRIMETHOPRIM

BAL PHARMA LTD-1, 2, 3 & SECTOR 69, SECTOR 4, IIE-PANTNAGARUDHAM SINGH NAGAR, RUDRAPUR-263153 UTTARAKHAND-INDIA

NEBIVOLOL+HYDROCHLOROTHIAZIDE

BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION-TEMPELHOFER WEG 83D-12347 BERLINGERMANY

BLISS GVS PHARMA LTD- PLOT 73 -76 SILVER INDUSTRIAL ESTATE BHIMPORE DAMAN 396 210 (UT)

CIPLA LIMITED-PLOT NO 9 & 10, PHARMA ZONE, PHASE II, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA.

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

Page 360: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ONDANSENTRON 4MG GERMANY

37.5MG + 325MG GERMANY

160MG +12.5MG GERMANY

320MG +12.5MG GERMANY

80MG +12.5MG GERMANY

ONDANSETRON 8MG GERMANY

MONTELUKAST SODIUM 10MG GERMANY

MONTELUKAST SODIUM 4MG GERMANY

MONTELUKAST SODIUM 5 MG GERMANY

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

TRAMADOL HYDROCHLORIDE + PARACETAMOL

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

VALSARTAN + HYDROCHLOROTHIAZIDE

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

VALSARTAN + HYDROCHLOROTHIAZIDE

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

VALSARTAN + HYDROCHLOROTHIAZIDE

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

DENK PHARMA GMBH & CO. KG -GOLLSTR. 1 84529 TITTMONING

Page 361: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SIMVASTATIN 20MG GERMANY

VITAMINS + MINERALS MULTI-INGREDIENT EGYPT

ALBENDAZOLE 20MG/ML EGYPT

2.5MG + 5MG EGYPT

CEFTRIAXONE DISODIUM 2G EGYPT

CEFTRIAXONE 1G EGYPT

CEFTRIAXONE SODIUM 500MG EGYPT

75IU/5ML EGYPT

EGYPT

DOXAZOCIN 2MG EGYPT

DENK PHARMA GMBH & CO-.GK GOII STR.1 84529 TIHMONING

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

CLIDINIUM BROMIDE + CHLORDIAZEPOXIDE

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

HUMAN MENOPAUSAL GONADOTROPHIN

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

FERROUS SULPHATE+FOLIC ACID+ASCORBIC ACID+THIAMINE MONONITRATE+RIBOTLAVINE+PYRIDOXINE HCL+NICOTINAMIDE+ZINC

150MG+0.5MG+50MG+2MG+2MG+1MG+10MG+25MG

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

Page 362: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OLOPATADINE HYDROCHLORIDE 1MG/ML EGYPT

TIMOLOL MALEATE 5MG/ML EGYPT

TENOXICAM 20MG EGYPT

FLUCONAZOLE 150MG EGYPT

NYSTATIN 100,000 I.U/ML EGYPT

5000I.U EGYPT

100MG EGYPT

GENTAMICIN SULPHATE 0.3W/V EGYPT

AMIKACIN SULPHATE 500MG/2ML EGYPT

INDIA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

HUMAN CHORIONIC GONADOTROPIN

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

HYDROCORTISONE SODIUM SUCCINATE

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY-10TH OF RAMADAN CITY FIRST INDUSTRIAL AREA

PARACETAMOL + IBUPROFEN + CAFFEINE

325MG + 400MG + 40MG

FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404

Page 363: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIPROFLOXACIN HYDROCHLORIDE 500MG INDIA

SUXAMETHONIUM CHLORIDE 100MG/2ML

TOPOTECAN HYDROCHLORIDE 4MG ITALY

KENYA

CHLORPHENIRAMINE MALEATE 4MG/10ML KENYA

ZOLEDRONIC ACID 4MG/5ML GERMANY

GRANISETRON HYDROCHLORIDE 1MG/ML GERMANY

EFAVIRENZ 600MG INDIA

CHLORHEXIDINE GLUCONATE 0.2 %W/V INDIA

40MG +320MG INDIA

PANTOPRAZOLE 40 MG INDIA

FREDUN PHARMACEUTICALS LTD-VEOOR PALGHAR ( E ) 401 404

FRESENIUS KABI MANUFACTURING S.A (PTY) LTD √-6 GIBAUD…ROAD KORSTEN, PORT ELIZABETH, SOUTH AFRICA.

SOUTH AFRICA

GLAXOSMITHKLINE MANUFACTURING S.P.A-STRADA PROVINCIALE ASOLANA, 9043056 SAN POLO DI TORRILE,PARMA ITALY

SODIUM BICARBONATE + CITRIC ACID

55.80%W/W + 43.20 %W/W

GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI

GLAXOSMITHKLINE-LIKONI ROAD IND. AREA, NAIROBI

HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELN

HAMELN PHARMACEUTICALS GMBH-LANGES FELD 13 31789 HAMELN

HETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA. IPCA HEALTH PRODUCTS LIMITED-286/287, GIDC, ANKLESHWAR-393002.GUJARAT, INDIA.

DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

Page 364: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

50MG + 12.5MG INDIA

ACECLOFENAC 200MG INDIA

ARTEMETHER + LUMEFANTRINE 20MG + 120MG INDIA

LOSARTAN 50MG INDIA

325MG + 37.5MG INDIA

AMITRIPTYLINE 25MG INDIA

AMPICILLIN 250MG INDIA

MULTI-INGREDIENT INDIA

DICLOFENAC DIETHYLAMINE 1.16%W/W INDIA

AMOXICILLIN 125MG/5ML INDIA

800MG + 160MG INDIA

LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

ACETAMINOPHEN + TRAMADOL HYDROCHLORIDE

IPCA LABORATORIES LTD-PLOT NO. 255/1,VILLAGE ATHAL,SILVASSA-396230,DADRA AND NAGAR HAVELI, INDIA.

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

5MG/ 2MG/ 500MG / 30MG

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

SULPHAMETHOXAZOLE + TRIMETHOPRIM

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

Page 365: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PREDNISOLONE 5MG INDIA

250MG+250MG INDIA

4MG/ML INDIA

DROTAVERINE 40MG INDIA

500MG+125MG CYPRUS

1000MG + 200MG CYPRUS

AMOXICILLIN + CLAVULANIC ACID 250MG + 125MG CYPRUS

CIPROFLOXACIN 500MG CYPRUS

MOMETASONE FUROATE 0.1%W/V CANADA

2MG + 5MG/ML BELGIUM

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM

LEBEN LABORATORIES PVT. LTD-PLOT NO. L-4, PHASE-III, MIDC, AKOLA– 444 104 (MS).

DEXAMETHASONE SODIUM PHOSPHATE

M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208NAVI MUMBAI, INDIA

M.J. BIOPHARM PVT. LTD-L-7, M.I.D.C. , TALOJA, DISTRICT RAIGAD - 410 208NAVI MUMBAI, INDIA

AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM

MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS

AMOXICILLIN SODIUM + CLAVULANIC ACID

MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS

MEDOCHEMIE LTD - FACTORY B-48 IAPETOU STREET, AGIOS ATHANASSIOS INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS

MEDOCHEMIE LTD (FACTORY AZ)-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS, INDUSTRIAL AREA, 4101 AGIOS ATHANASSIOS, LIMASSOL, CYPRUS

MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA

BETAMETHASONE DISODIUM PHOSPHATE + BETAMETHASONE DIPROPIONATE

MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG

Page 366: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DESLORATADINE 0.5MG/ML

DACLATASVIR + SOFOSBUVIR 60MG + 400MG INDIA

LEDIPASVIR + SOFOSBUVIR 90MG + 400MG INDIA

1 G + 0.2 G NEPAL

PARACETAMOL 500MG NEPAL

GENTAMICIN SULPHATE 0.3%W/V NEPAL

LIDOCAINE HYDROCHLORIDE 2% W/V INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML NEPAL

VITAMIN A 200,000 IU INDIA

5MG + 10MG INDIA

NYSTATIN 100000 I.U/ML UGANDA

MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA,SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG

SOUTH AFRICA/NETHERLANDS

MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.

MYLAN LABORATORIES LIMITED-F- 4 & F-12, MIDC, MALEGAON,SINNAR, NASHIK -422 113 MAHARASHTRA, INDIA.

AMOXICILLIN SODIUM + POTASSIUM CLAVULANATE

NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA

NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA

NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA

NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA

NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA

OLIVE HEALTHCARE-197/2, ATHIYAWAD DABHEL VILLAGE DAMAN 396210 (U.T)

LEVOCETIRIZINE DIHYDROCHLORIDE + MONTELUKAST SODIUM

RAVIAN LIFE SCIENCE PVT LTD-PLOT NO.34,SECTOR-8A,IIE,HARIDWAR-249403, UTTARKHAND

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

Page 367: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CHLOROQUINE PHOSPHATE 250MG UGANDA

AMPICILIN TRIHYDRATE 250MG UGANDA

AMOXICILLIN TRIHYDRATE 250MG UGANDA

ASCORBIC ACID 100MG UGANDA

PARACETAMOL 120MG/5ML UGANDA

AMPICILLIN + CLOXACILLIN UGANDA

DICLOFENAC SODIUM BP 50MG UGANDA

SULPHADIMIDINE 500MG UGANDA

IBUPROFEN 200MG UGANDA

GLIMEPIRIDE 1MG

MULTI-INGREDIENTS MULTI-INGREDIENTS EGYPT

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

125MG+125MG/5ML

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

RENE INDUSTRIES LTD-680,KAMULI,KIREKAKAMPALA,UGANDA

SANOFI AVENTIS-2 BOND STREET MIDRAND 1685 SOUTH AFRICA

SOUTH AFRICA

SOUTH EGYPT DRUG INDUSTRIES CO. (SEDICO)-1ST INDUSTRIAL ZONE, S" OF OCTOBER CITY, EGYPT.PO. BOX 43, OCTOBER CITY. POSTAL CODE NO.12566

Page 368: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LEVOFLOXACIN HEMIHYDRATE 750MG BANGLADESH

LOMEFLOXACIN HYDROCHLORIDE 0.3%W/V BANGLADESH

DOMPERIDONE 10MG BANGLADESH

SALBUTAMOL SULPHATE 2.5MG/2.5ML BANGLADESH

BANGLADESH

KETOTIFEN FUMARATE 0.025%W/V BANGLADESH

DICLOFENAC SODIUM 100MG BANGLADESH

CIPROFLOXACIN HYDROCHLORIDE 0.3%W/V BANGLADESH

150 MG + 750 MG INDIA

PANTOPRAZOLE SODIUM 40MG INDIA

IBUPROFEN + PARACETAMOL 400MG + 300MG INDIA

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

FERROUS SULPHATE+FOLIC ACID+THIAMINE MONONITRATE+RIBOFLAVIN+PYRIDOXINE HYDROCHLORIDE+NICOTINAMIDE+ASCORBIC ACID

150MG+0.5MG+2MG+2MG+1MG+10MG+50MG

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

SQUARE PHARMACEUTICALS LTD - DHAKA UNIT KALIAKOIR GAZIPUR

ARTEROLANE MALEATE + PIPERAQUINE PHOSPHATE

SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA

SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA

SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA

Page 369: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

ETORICOXIB 90MG INDIA

ETORICOXIB 120MG INDIA

BUPIVACAINE 5MG/ML INDIA

BUPIVACAINE HYDROCHLORIDE 5MG/ML INDIA

DROTAVERINE HYDROCHLORIDE 40MG INDIA

MIDAZOLAM 1MG/ML INDIA

50MG + 500MG INDIA

DICLOFENAC SODIUM 75MG/ML INDIA

DICLOFENAC SODIUM 100MG INDIA

325MG+675MG INDIA

SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA

SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA

SUN PHARMACEUTICAL INDUSTRIES LIMITED-SUN HOUSE, PLOT NO. 201 B/1 WESTERN EXPRESS HIGHWAY, GOREGAON (EAST), MUMBAI, INDIA

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

DICLOFENAC SODIUM + PARACETAMOL

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

PARACETAMOL BP(IMMEDIATE RELEASE)+ PARACETAMOL BP(EXTENDED RELEASE)

TROIKAA PHARMACEUTICALS LTD .-SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND, INDIA

Page 370: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ROCURONIUM BROMIDE 10MG INDIA

CLOMIPHENE 50MG MALAYSIA

DICLOFENAC 10MG/ML MALAYSIA

AMLODIPINE BESYLATE 10MG MALAYSIA

IRBESARTAN 150MG CHINA

IRBESARTAN 300MG CHINA

300MG + 12.5MG CHINA

150MG + 12.5MG CHINA

IRBESARTAN 150MG CHINA

TROIKAA PHARMACEUTICALS LTD- SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197 UTTARAKHAND

Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN

Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN

Y.S.P INDUSTRIES (M) SDN BDH - LOT 3,5 & 7 P/7 SECTION 13 KAWASAN PERINDUSTRIAN BANDAR BARU BANGI 43000 KAJANG SELANGOR DARUL EHSAN

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA

IRBESARTAN + HYDROCHLOROTHIAZIDE

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA

IRBESARTAN + HYDROCHLOROTHIAZIDE

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA,DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS

Page 371: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IRBESARTAN 300MG CHINA

EFAVIRENZ 600MG

EFAVIRENZ 200MG

EFAVIRENZ 50MG

CEFIXIME TRIHYDRATE 200MG INDIA

CLOPIDOGREL BISULFATE 75MG INDIA

CELECOXIB 200 MG INDIA

CEFIXIME TRIHYDRATE 100MG INDIA

20MG INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA,DELORBIS PHARMACEUTICALS LTD-17 ATHINON STR., ERGATES INDUSTRIAL AREA, 2643 ERGATES, P.O. BOX 28629, 2081 LEFKOSIA, CYPRUS

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA,MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEM

CHINA/NETHERLANDS

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEM

CHINA/NETHERLANDS

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD-XUNQIAO, LINHAI, ZHEJIANG PROVINCE 317024 PEOPLES’ REPUBLIC OF CHINA,MERCK SHARP & DOHME.-WAADERWAG 39, POSTBUS 581. 2003 PC HAARLEM

CHINA/NETHERLANDS

ZIM LABORATORIES LIMITED-B-21122, MIDC AREA,KALMESHWAR -441 501,DIST. NAGPUR,INDIA.

ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR – 441501,DIST. NAGPUR,MAHARASHTRA,

ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR – 441501,DIST. NAGPUR,MAHARASHTRA,

ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR – 441501,DIST. NAGPUR,MAHARASHTRA,

ATORVASTATIN CALCIUM (TRIHYDRATE)

ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR – 441501,DIST. NAGPUR,MAHARASHTRA,

ZIM LABORATORIES LTD-B-21/22, M.I.D.C. AREA,KALMESHWAR – 441501,DIST. NAGPUR,MAHARASHTRA,

Page 372: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BENZYLPENICILLIN 1MU CHINA

UGANDA

HEPARIN SODIUM 1000I.U/G ITALY

KETOPROFEN 2.5%W/W ITALY

ZOFENOPRIL 30MG ITALY

DEXKETOPROFEN TROMETAMOL 25MG ITALY

OTILONIUM BROMIDE 40MG ITALY

0.1%W/V UGANDA

CHLORAMPHENICOL 5%W/V UGANDA

GENTAMICIN SULPHATE 0.3% W/V UGANDA

,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

GLUCOSE ANHYDROUS+TRISODIUM CITRATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE

6.75G + 1.45G + 1.3G + 0.75G

: MEDIPHARM INDUSTRIES LTD-PLOT 65, KAKAJJO ROAD, BWEYOGERERE POSTAL ADDRESS : P.O.BOX 5917, KAMPALA.

A. MENARINI MANUFACTURING LOGICTICS AND SERVICES-VIA 3 SETTE SANTI FLORENCE 50131 ITALY

A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA SETTE SANTI 3, 50131 FIRENZE-ITALY

A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILA

A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.I-VIA CAMPO DI PILE 67100 L'AQUILA

A.MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L-VIA CAMPO DI PILE, L’AQUILA (AQ), ITALY

BETAMETHASONE SODIUM PHOSPHATE

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

Page 373: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GLUCOSE 5%W/V UGANDA

SODIUM CHLORIDE + GLUCOSE 0.9%W/V + 5% W/V UGANDA

WATER FOR INJECTION NEUTRAL UGANDA

GLUCOSE INTRAVENOUS INFUSION 50%W/V UGANDA

FLUCONAZOLE 200MG UGANDA

BORIC ACID 1.83%W/V UGANDA

LEVOFLOXACIN HEMIHYDRATE 5G/L UGANDA

ARTESUNATE 120MG UGANDA

NORFLOXACIN 0.3%W/V UGANDA

UGANDA

MANNITOL 200MG/ML UGANDA

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-BLOCK 191, PLOT NO. 114, GWAWANYA KINGA AND KAPEKA MUKONO DISTRICT, UGANDA.

ABACUS PARENTERAL DRUGS LIMITED-PLOT 114, BLOCK 191

COMPOUND SODIUM LACTATE INFUSION BP

0.6/ 0.25 /0.04 / 0.027 % W/V

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

Page 374: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE 500MG UGANDA

SODIUM CHLORIDE 0.9%W/V UGANDA

SODIUM CROMOGLICATE 2%W/V UGANDA

0.1 % W/V UGANDA

DEXAMETHASONE+NEOMYCIN 0.1W/V+ 0.35W/V UGANDA

STERILE WATER FOR IRRIGATION N/A UGANDA

GLUCOSE 10%W/V UGANDA

CHLORAMPHENICOL 0.5% W/V UGANDA

CIPROFLOXACIN 0.3%W/V UGANDA

TIMOLOL MALEATE 0.5% W/V UGANDA

BETAMETHASONE + NEOMYCIN 0.1%W/V +0.5%W/V UGANDA

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

DEXAMETHASONE SODIUM PHOSPHATE

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

Page 375: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SODIUM CHLORIDE 0.9% W/V UGANDA

UGANDA

CIPROFLOXACIN 0.2%W/V UGANDA

CIPROFLOXACIN HYDROCHLORIDE 2MG/ML INDIA

DYDROGESTERONE 10MG

15µG + 15µG +15µG

CETRORELIX 0.25MG FRANCE

LOPINAVIR+RITONAVIR 200MG+50MG GERMANY

LOPINAVIR/ RITONAVIR 100MG/25MG GERMANY

RITONAVIR 100MG GERMANY

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

POTASSIUM CHLORIDE+SODIUM CHLORIDE+SODIUM LACTATE

0.13% + 0.20% + 0.30%

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABACUS PARENTERAL DRUGS LTD.-PLOT NO. 114, BLOCK 191, GWAGAMYA, KINGA, KAPEKE, MUKONO

ABARIS HEALTHCARE PVT. LTD.---406, SAFFRON, PANCHVATI, AMBAVADI, AHMEDABAD - 380 006, GUJARAT, INDIA

ABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLST

NETHERLANDS

INACTIVATED INFLUEZA VACCINE-SURFACE ANTIGEN [A/CALIFORNIA/7/2009(H1N1) PDM09 + A/SWITZERLAND /9715293/2013(H3N2) + B/PHUKET/3073/2013-LIKE STRAINS]

ABBOTT BIOLOGICALS B.V -ABBOTT BIOLOGICALS B.V VEERWEG 12 8121 AA OLST

NETHERLANDS

ABBOTT BIOLOGICALS B.V VEERWEG -12,NL-8121 AA OLST THE NETHERLANDS,PIERRE FABRE MEDICAMENT -AQUITAINE PHARM INTERNATIONAL SITE 1

ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.

ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.

ABBVIE DEUTSCHLAND GMBH & CO. KG.-KNOLLSTASSE 50, D-67061, LUDWIGSHAFEN, GERMANY.

Page 376: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BERACTANT 100MG/4ML

240MG/4MG GERMANY

MEFLOQUINE 250MG SWITZERLAND

DICLOFENAC SODIUM 100MG SWITZERLAND

MULTIVITAMIN MULTINGREDIENT SWITZERLAND

CLOPIDOGREL BESILATE 75MG SWITZERLAND

GERMANY

OMEPRAZOLE 20MG SWITZERLAND

CIPROFLOXACIN 500MG SWITZERLAND

MULTINGREDIENT MULTINGREDIENT SWITZERLAND

ALPRAZOLAM 0.25MG INDIA

ABBVIE NORTH CHICAGO FACILITY-1401 SHERDAN ROAD NORTH CHICAGO FACILITY ILLINOIS 60064 -4000

UNITED STATES

VERAPAMIL HYDROCHLORIDE + TRANDOLAPRIL

ABOTT GMBH & CO KG -KNOLLSTRASSE 67061 LUDWIGSHAFEN

ACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL

ACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL

ACINO PHARMA AG (FORMER MEPHA LLC)-DORNACHERSTRASSE 114 P.O BOX 445 CH4147, AESCH/BL

ACINO PHARMA AG .-BIRSWEG 2 4253 LIESBERG BASEL LAND

VITAMIN B1+VITAMIN B6+VITAMIN B12

100MG+100MG+1MG

ACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND

ACINO PHARMA AG -DORNACHERSTRASSE, 114, 4147, AESCH, SWITZERLAND

ACINO PHARMA AG.-DORNACHERSTRASSE 114, CH-4147 AESCH, SWITZERLAND

ACINO PHARMA AG-DORNACHERSTRASSE 114 P.O.BOX 445 CH4147 AESCH/BL SWITZERLAND

ACME FORMULATION PVT LTD -ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH

Page 377: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MISOPROSTOL 200MCG INDIA

OMEPRAZOLE DELAYED-RELEASE 20MG INDIA

LEVONORGESTREL 1.5MG INDIA

OFLOXACIN + ORNIDAZOLE 200MG + 500MG INDIA

AZITHROMYCIN 500MG INDIA

HEPARIN SODIUM 1000IU/ML INDIA

WATER FOR INJECTION N/A INDIA

SODIUM CHLORIDE 0.9 % W/V INDIA

COMPOUND SODIUM LACTATE MULTI INGREDIENT INDIA

DEXTROSE 5%W/V INDIA

METRONIDAZOLE 500MG/100ML INDIA

ACME FORMULATION PVT LTD,-ACME FORMULATION PVT LTD ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH

ACME FORMULATION PVT LTD.-ROPAR ROAD NALAGARH DIST SOLAN HIMACHAL PRADESH

ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA

ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA

ACME FORMULATION PVT LTD.-ROPAR ROAD, NALAGARH, DIST. SOLAN, HIMACHAL PRADESH 174101 INDIA

ACULIFE HEALTH CARE, FORMALLY NIRMA(HEALTHCARE DIVISION)-VILLAGE: SACHANA, TALUKA: VIRAMGAM DISTRICT: AHMEDABAD-382150 GUJARAT, INDIA

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

Page 378: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIPROFLOXACIN 200MG/100MG INDIA

PROPOFOL 1%W/V INDIA

MEROPENEM SODIUM 1000MG INDIA

CEFTRIAXONE SODIUM 1000MG INDIA

MEROPENEM 500MG INDIA

BUPIVACAINE HYDROCHLORIDE BP 5 MG/ML INDIA

BISACODYL 5 MG INDIA

CHLORPHENIRAMINE MALEATE 4MG INDIA

PARACETAMOL 500MG INDIA

INDIA

INDIA

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ACULIFE HEALTHCARE PVT. LTD-VILLAGE SACHANA ,TALUKA - VIRAMGAM , AHMEDABAD 382150 GUJARAT

ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA

ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA

ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA

PARACETAMOL+CODEINE PHOSPHATE+DOXYLAMINE+CAFFEINE

450 MG+10 MG+5 MG+50 MG

ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA

PARACETAMOL+ASPIRIN+CAFFEINE ANHYDROUS

100MG+400MG+130MG

ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE 560099, KARNATAKA STATE, INDIA

Page 379: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

20MG GERMANY

40MG GERMANY

SALBUTAMOL 100MCG AEROPHARM GMBH...-RUDOLSTADT ALLEMAGNE GERMANY

50MG + 1000MG

50MG + 850MG

ISOFLURANE 99.9%W/V

RITONAVIR 80MG/ML

SEVOFLURANE 100%W/W

MAGNESIUM TRISILICATE 370MG INDIA

MEBENDAZOLE 100MG INDIA

PARACETAMOL + IBUPROFEN + CODEINE PHOSPHATE

250MG + 200MG + 10MG

ADCOCK INGRAM LIMITED-49C & D BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK, BANGALORE560099, KARNATAKA STATE, INDIA

PANTOPRAZOLE SODIUM SESQUIHYDRATE

ADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN

PANTOPRAZOLE SODIUM SESQUIHYDRATE

ADVANCE PHARMA GMBH..-WALLENRODER STR.12-14, 13435 BERLIN

SITAGLIPTIN + METFORMIN HYDROCHLORIDE

AESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM

UNITED KINGDOM

SITAGLIPTIN + METFORMIN HYDROCHLORIDE

AESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM

UNITED KINGDOM

AESICA QUEESNBOROUGH LTD .-NORTH ROAD, QUEENBOROUGH KENT ME 11 5EL, UNITED KINGDOM

UNITED KINGDOM

AESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENT

UNITED KINGDOM

AESICA QUEESNBOROUGH LTD- NORTH RD. QUEENSBOROUGH KENT

UNITED KINGDOM

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.

Page 380: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FOLIC ACID 5MG INDIA

FUROSEMIDE 40MG INDIA

PARACETAMOL 500MG INDIA

GLIBENCLAMIDE 5MG INDIA

INDIA

MULTI-INGREDIENT N/A INDIA

DOXYCYCLINE 100MG INDIA

800MG/160MG INDIA

INDIA

KETOCONAZOLE USP 200 MG INDIA

PROMETHAZINE 5MG/5ML INDIA

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.

AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

FERRIC AMMONIUM+FOLIC ACID+PYRIDOXINE+THIAMINE

50+0.55+2.4+1.2 MG

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

SULFAMETHOXAZOLE/TRIMETHOPRIM

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

PARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/DIPHENHYDRAMINE/CAFFEINE

400MG/5MG/12.5MG/30MG

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

Page 381: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PARACETAMOL 500 MG INDIA

INDIA

DEXAMETHASONE 0.5MG INDIA

DICLOFENAC SODIUM 50MG INDIA

CYPROHEPTADINE 4MG INDIA

TETRACYCLINE 3%W/W INDIA

LEVAMISOLE HYDROCHLORIDE 40MG INDIA

BENZYL BENZOATE 25%W/W INDIA

BETAMETHASONE 0.1%W/W INDIA

BETAMETHASONE + NEOMYCIN INDIA

BETAMETHASONE VALERATE 0.1%W/W INDIA

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

PARACETAMOL+PHENYLEPHRINE HCL+CAFFEINE+CHLORPHENIRAMINE HYDROCHLORIDE

500.MG+5.0MG+30.0MG+2.0MG

AGOG PHARMA LIMITED-PLOT NO.33,SECTOR II,THE VASAI TALUKA INDL.CO-OP ESTATE LTD.VASAI(E) DIST.THANE,INDIA

AGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD.-NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD.-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

0.1%W/W + 0.5% W/W

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

Page 382: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

CIMETIDINE 400MG INDIA

DICLOFENAC DIETHYLAMINE 1%W/W INDIA

FLUCONAZOLE 200 INDIA

METHYLDOPA 250MG INDIA

PARACETAMOL 500 MG INDIA

PHENYTOIN 100MG INDIA

PHENYTOIN 100MG INDIA

1%W/W + 0.20W/W INDIA

ZINC SULPHATE 20MG INDIA

CIMEDITINE 200MG INDIA

BETAMETHASONE+NEOMYCIN SULPHATE

0.1%W/W+0.5%W/W

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

Page 383: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DICLOFENAC 50MG INDIA

PREDNISOLONE 5MG INDIA

FUROSEMIDE 40MG INDIA

QUININE SULPHATE 300MG INDIA

ERYTHROMYCIN ESTOLATE 125MG/5ML INDIA

LOPERAMIDE HYDROCHLORIDE USP 2MG INDIA

PARACETAMOL 125 MG/5ML INDIA

CHLORPROMAZINE 100MG INDIA

CARBAMAZEPINE 200 MG INDIA

INDIA

ACETYL SALICYLIC ACID 300MG INDIA

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

PARACETAMOL/ DEXTROMETHORPHAN HCL/ CHLORPHENIRAMINE

500MG/ 15MG/ 2MG /10MG

AGOG PHARMA LTD-PLOT NO. 33, SECTOR II, VASAI, TALUKA INDL.

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 384: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACICLOVIR 5% W/W INDIA

AMINOPHYLLINE 100MG INDIA

INDIA

ATENOLOL 50MG INDIA

AZITHROMYCIN 250MG INDIA

BISACODYL 5MG INDIA

CALAMINE 15%W/W INDIA

CETIRIZINE 5MG/5ML INDIA

CHLORHEXIDINE GLUCONATE 4 INDIA

CLOTRIMAZOLE 1 INDIA

CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

ANHYDROUS GLUCOSE/SODIUM CHLORIDE/TRISODIUM CITRATE/POTASSIUM CHLORIDE

(2.7G/0.52G/0.58G/0.3G)/20MG

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 385: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DAPSONE 100MG INDIA

HYOSCINE BUTYLBROMIDE 10MG INDIA

IBUPROFEN + PARACETAMOL INDIA

MEFENAMIC ACID 250MG INDIA

INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

NALIDIXIC ACID 500MG INDIA

NEOMYCIN SULPHATE 0.5% W/W INDIA

NIFEDIPINE 20MG INDIA

NORFLOXACIN 400MG INDIA

PARACETAMOL 500MG INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

100MG + 162.5MG /5ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

MICONAZOLE NITRATE+NEOMYCIN SULPHATE+CLOBETASOL PROPIONATE

2.0%W/W+0.5%W/W+0.05%W/W

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 386: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PROMETHAZINE HCL 25MG INDIA

QUININE HYDROCHLORIDE 100MG/5ML INDIA

QUININE SULPHATE 300MG INDIA

TETRACYCLINE HYDROCHLORIDE 250MG INDIA

TRAMADOL 50MG INDIA

INDIA

BENDROFLUMETHIAZIDE 5MG INDIA

ACETYL SALICYLIC ACID 100MG INDIA

SALBUTAMOL SULPHATE 4MG INDIA

METRONIDAZOLE 200MG INDIA

LACTULOSE 3.35MG/5ML INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

VITAMIN B1 + VITAMIN B2 + NICOTINAMIDE + VITAMIN B6

1.0 MG + 1.0 MG + 15 MG + 0.5 MG

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 387: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GRISEOFULVIN TABLETS 500MG INDIA

NITROFURANTOIN BP 100MG INDIA

INDIA

INDIA

INDIA

TERBINAFINE 250MG INDIA

PRAZIQUANTEL 600MG INDIA

CHLORPHENIRAMINE MALEATE 2MG/5ML INDIA

SILDENAFIL 100MG INDIA

AZITHROMYCIN 500MG INDIA

AZITHROMYCIN 250MG INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

TERBUTALINE SULPHATE +GUAIFENESIN+BROMOHEXINE HCL+LEVOMENTHOL

1.25MG/5ML+50MG//5ML+4MG/5ML+2.5MG/5ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

PARACETAMOL+PHENYLEPHRINE+CHLORPHENIRAMINE+SODIUM CITRATE

125MG/5ML+2.5MG/5ML+1MG/5ML+60MG /5ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE

250MG/5ML+ 250MG/5ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 388: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

FERROUS SULPHATE 200MG INDIA

MEBENDAZOLE 100MG/5ML INDIA

MEBENDAZOLE 100MG INDIA

IBUPROFEN 200MG INDIA

FERROUS SULPHATE+FOLIC ACID 200MG + 0.25MG INDIA

METFORMIN 500MG INDIA

HYDROCORTISONE 0.1%W/W INDIA

METRONIDAZOLE 200MG INDIA

METRONIDAZOLE BENZOATE 125MG/5ML INDIA

METRONIDAZOLE 200MG INDIA

BROMHEXINE HCL+DEXTROMETHORPHAN HBR+AMMONIUM CHLORIDE+MENTHOL

4MG/5ML+5MG/5ML+50MG/5ML+2.5MG/5ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 389: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE 200MG INDIA

MAGNESIUM TRISILICATE 250MG INDIA

MULTIVITAMIN MULTI-INGREDIENT INDIA

FOLIC ACID 5MG INDIA

INDOMETHACIN 25MG INDIA

ITRACONAZOLE 100MG INDIA

DIGOXIN 0.25MG INDIA

INDIA

IBUPROFEN 200MG INDIA

CHLORPHENIRAMINE 4MG INDIA

CIPROFLOXACIN 500MG INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

IBUPROFEN + PARACETAMOL + CAFFEINE

200MG + 325MG + 30MG

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 390: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

ARTEMETHER + LUMEFANTRINE 20MG + 120MG INDIA

SALBUTAMOL 2MG/5ML INDIA

CALCIUM LACTATE 300MG INDIA

CLOTRIMAZOLE 100MG INDIA

ACTIVATED CHARCOAL 0.25MG INDIA

INDIA

AMOXICILLIN TRIHYDRATE 250MG INDIA

AZITHROMYCIN 500MG INDIA

ARTEMETHER + LUMEFANTRINE INDIA

PYRIDOXINE 25MG INDIA

PARACETAMOL+IBUPROFEN+CAFFEINE

500MG+200MG+30MG

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

ANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE DIHYDRATE,POTASSIUM CHLORIDE

2.7G + 0.52G + 0.58G + 0.30G/ 200ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

PER 5ML: 15MG + 90MG

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 391: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TRIFLUOPERAZINE 5MG INDIA

CO-TRIMOXAZOLE 100MG/20MG INDIA

OMEPRAZOLE 20MG INDIA

ATENOLOL 100MG INDIA

VITAMIN B COMPLEX BPC FORMULA INDIA

HALOPERIDOL 10MG INDIA

ISONIAZID 100MG INDIA

PARACETAMOL 100MG INDIA

PROPANOLOL 40MG INDIA

MEBENDAZOLE 100MG INDIA

INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

ANHYDROUS GLUCOSE,SODIUM CHLORIDE,TRISODIUM CITRATE,POTASSIUM CHLORIDE

2.7G/200ML,0.52G/200ML,0.58G/200ML,0.30G/200ML

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 392: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTEMETHER + LUMEFANTRINE 180 MG + 1080 MG INDIA

FERROUS SULPHATE + FOLIC ACID 200MG + 0.4MG INDIA

CO-TRIMOXAZOLE 240MG/5ML INDIA

CO-TRIMOXAZOLE 480MG INDIA

ACICLOVIR 200MG INDIA

ALBENDAZOLE 400MG INDIA

ALBENDAZOLE USP 200 MG/ 5 ML INDIA

TINIDAZOLE 500MG INDIA

PIROXICAM 20MG INDIA

CHLORAMPHENICOL 125MG/5ML INDIA

MAGNESIUM TRISILICATE 370MG INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 393: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SILDENAFIL CITRATE 50MG INDIA

ERYTHROMYCIN STEARATE 250MG INDIA

AMITRIPTYLINE 25 MG INDIA

IBUPROFEN 100MG/5ML INDIA

CETIRIZINE 10MG INDIA

CHLORAMPHENICOL 250MG INDIA

NYSTATIN 100000 IU INDIA

SILVER SULFADIAZINE 1%W/W INDIA

VITAMIN C 100MG INDIA

HYDROCORTISONE ACETATE 1%W/W INDIA

INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

ANHYDROUS GLUCOSE + SODIUM CHLORIDE + TRISODIUM CITRATE + POTASSIUM CHLORIDE

13.50G + 2.60G + 2.90G +1.50G/ 1L

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

Page 394: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NYSTATIN 500,000I.U INDIA

PEFLOXACIN 400MG INDIA

ERYTHROMYCIN ESTOLATE 125MG/5ML INDIA

GENTAMICIN SULFATE 0.3%W/V INDIA

GENTAMYCIN SULPHATE 0.3%W/V INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

MOXIFLOXACIN 400MG/100ML INDIA

INDIA

SODIUM CROMOGLICATE 2%W/V INDIA

TIMOLOL MALEATE O.5%W/V INDIA

AGOG PHARMA LTD-PLOT NO.33,SECTOR II,VASAI,TALUKA INDL CO-OP ESTATE LTD,GAURAI PADA,VASAI(E)DIST.THANE INDIA

AGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA

AGOG PHARMA-PLOT 33 SECTOR THE VASAI-TULUKA CO-OP ESTATE LTD INDIA

AHLCON PARENTERAL (I) LTD.--SP-918,BHLWADI (RAJ) INDIA M.LIC.: RAJ 2002

AHLCON PARENTERALS (I) LIMITED-SP-918,INDUSTRIAL AREA,PHASE III BHIWADI DIST, ALWAR (RAJASTHAN) INDIA

AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN

AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN

DEXAMATHASONE SODIUM PHOSPHATE+NEOMYCIN SULPHATE

0.35%W/V+0.1%W/V

AHLCON PARENTERALS (INDIA) LTD-SP-917-918, PHASE-III BHIWADI-301019, ALWAR, RAJASTHAN

AHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)TEL: +91-1493-305300 (30 LINES)FAX: +91-1493-221045, 305345

AHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)TEL: +91-1493-305300 (30 LINES)FAX: +91-1493-221045, 305345

Page 395: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CARMELLOSE SODIUM 0.5%W/V INDIA

PANTOPRAZOLE SODIUM 20MG INDIA

PIOGLITAZONE 15MG INDIA

ATORVASTATIN CALCIUM 10MG INDIA

PIOGLITAZONE HYDROCHLORIDE 30MG INDIA

PANTOPRAZOLE 40MG INDIA

ATORVASTATIN CALCIUM 20MG INDIA

AZITHROMYCIN 200MG/5ML INDIA

INDIA

MEFENAMIC ACID 50MG/5ML INDIA

AHLCONPARENTERALS (INDIA) LIMITED-SP-918, PHASE-III, BHIWADI-301019, RAJASTHAN (INDIA)TEL: +91-1493-305300 (30 LINES)FAX: +91-1493-221045, 305345

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD .-NO. 172 & 173, APPAREL PARK ROAD, DULAPALLY VILLAGE, QUTHBULLAPUR - MANDAL RR DIST HYDERABAD 500100, TELANGANA

AIZANT DRUG RESEARCH SOLUTIONS PVT LTD.-SY. N0. 172 & 173,PARK ROAD, DULAPALLY VILLAGE

AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE

SODIUM FEREDETATE + PYRIDOXINE + CYANOCOBALAMIN + FOLIC ACID

216.87MG + 1.5MG + 7.5MCG + 1.5MG

AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE

AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE

Page 396: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IBUPROFEN + PARACETAMOL INDIA

INDIA

INDIA

INDIA

CANDESARTAN CILEXETIL 8MG INDIA

ARTEMETHER + LUMEFANTRINE 20MG + 120MG INDIA

TADALAFIL 20MG INDIA

40MG + 320MG INDIA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

ARTEMETHER + LUMEFANTRINE 40 MG + 40 MG INDIA

ARTEMETHER + LUMEFANTRINE 80 MG + 480 MG INDIA

100MG + 162.5 MG /5ML

AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE

CHLOROPHENERAMINE + PARACETAMOL + VITAMIN C

0.5MG + 120MG + 50MG

AJANTA PHARMA LIMITED-31-0 MIDC INDUSTRIAL AREA CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA STATE

CARBONYL IRON + FOLIC ACID + VITAMIN B12 + VITAMIN C + ZINC SULFATE MONOHYDRATE

100MG+1.5 MG + 15 MCG + 75 MG + 61.8 MG

AJANTA PHARMA LIMITED-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.

VITAMIN C/ VITAMIN A/ ZINC SULPHATE

150MG/10MG/75MG

AJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.

AJANTA PHARMA LIMITED-B-4-5-6, MIDC AREA PAITHAN, AURANGABAD, 431148 DIST:AURANGABAD MAHARASHTRA, INDIA.

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

DIHYDROARTEMISININ + PIPERAQUINE

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

Page 397: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTESUNATE + AMODIAQUINE 100 MG + 270 MG INDIA

AZITHROMYCIN 250 MG INDIA

SILDENAFIL CITRATE 100MG INDIA

CLARITHROMYCIN 500MG INDIA

ACECLOFENAC 100MG INDIA

ACECLOFENAC + PARACETAMOL 100 MG + 500 MG INDIA

ARTEMETHER+LUMEFANTRINE 180MG+1080MG INDIA

ATORVASTATIN 10MG INDIA

150MG + 1G + 1G INDIA

SILDENAFIL 50MG INDIA

AZITHROMYCIN 500MG INDIA

AJANTA PHARMA LTD .-B-4//5/6, MIDC INDUSTRIALAREA, PAITHAN-431 128, AURANGBAD

AJANTA PHARMA LTD .-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIA

AJANTA PHARMA LTD .-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIA

AJANTA PHARMA LTD .-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIA

AJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA, P

AJANTA PHARMA LTD, B-4/5/6 MIDC INDUSTRIAL AREA, P

AJANTA PHARMA LTD.-B-41516, MIDC INDUSTRIAL AREA,PAITHAN, AURANGABAD-431 148 DIST: AURANGABAD MAHARASHTRA,INDIA

AJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PAITHAN 431125, MAHARASHTRA INDIA

FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE

AJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PAITHAN 431125, MAHARASHTRA INDIA

AJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIA

AJANTA PHARMA LTD.-B-4-5-6 MIDC IND AREA, PARTHEN 431125, MAHARASHTRA INDIA

Page 398: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTESUNATE + AMODIAQUINE 25 MG + 67.5 MG INDIA

ARTESUNATE+AMODIAQUINE 50MG+135MG INDIA

CLOPIDOGREL 75MG INDIA

LANSOPRAZOLE 30MG INDIA

ATORVASTATIN 20MG INDIA

INDIA

PARACETAMOL + IBUPROFEN 325MG + 400MG INDIA

PROGESTERONE 100MG/ML INDIA

PROGESTERONE 200 MG INDIA

RISPERIDONE 4MG INDIA

CEFIXIME TRIHYDRATE 400MG INDIA

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

OMEPRAZOLE + SODIUM BICARBONATE

20MG/6G + 1680MG/6G

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

AJANTA PHARMA LTD--B-4/5/6 MIDC INDUSTRIAL AREA PAITHAN 431 128 AURANGABAD

AKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD .-47, 48 SECTOR 6A I.I.E SIDCUL RANIPUR HARIDWAR 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA

Page 399: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1MG + 500MG INDIA

RABEPRAZOLE SODIUM 20MG INDIA

CEFUROXIME AXETIL 250MG INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

CEFTRIAXONE SODIUM 1G/VIAL INDIA

IRON SUCROSE 20MG/ML INDIA

1000MG + 500MG INDIA

METHYLCOBALAMIN 1500 MCG/ML INDIA

PIPERACILLIN +TAZOBACTAM 4G + 0.5G INDIA

PARACETAMOL 1.0%W/V INDIA

CEFUROXIME AXETIL 500MG INDIA

GLIMEPIRIDE + METFORMIN HYDROCHLORIDE

AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD --19,20,21, SECTOR 6A, I.I.E, SIDCUL, RANIPUR, HARIDWAR 249403 DISTRICT: UTTARAKHAND INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD. -PLANT III,-PLOT NO. 2, 3, 4 & 5, SECTOR 6-B, IIE, SIDCUL,RANIPUR, 249 403

CEFOPERAZONE SODIUM+SULBACTAM SODIUM

AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD.-2, 3, 4, & 5, SEC-6B, I.I.E., SIDCUL, RANIPUR, HARIDWAR-249403 (INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA

Page 400: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MOXIFLOXACIN HYDROCHLORIDE 0.4%W/V INDIA

PREGABALIN 75 MG INDIA

ACECLOFENAC+PARACETAMOL 100MG+500MG INDIA

ACECLOFENAC 100MG INDIA

ACECLOFENAC 100MG INDIA

DESLORATIDINE 5MG, INDIA

INDIA

INDIA

AZITHROMYCIN 500MG INDIA

CEFIXIME TRIHYDRATE 100MG INDIA

500MG + 125MG INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD.-PLANT III, PLOT NO. 19, 20, 21, SECTOR 6-A, IIE, SIDCUL, RANIPUR, DISTRICT: UTTARAKHAND INDIA

AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403

AKUMS DRUGS & PHARMACEUTICALS LTD-19, 20,21 SECTOR 6A IIE SIDCUL RANIPUR HARIDWAR 249 403

BROMHEXINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + AMMONIUM CHLORIDE

8MG + 10MG + 100MG

AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA

TERBUTALINE SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN

2.5MG + 8MG + 100MG

AKUMS DRUGS & PHARMACEUTICALS LTD-PLANT II-PLOT NO.22, SECTOR 6-A, IIE, SIDCUL, RANIPUR,DISTRICT: HARIDWAR 249 403, INDIA

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

Page 401: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MOXIFLOXACIN HYDROCHLORIDE 400MG INDIA

100MG + 60MG INDIA

INDIA

MONTELUKAST SODIUM 10MG INDIA

5MG + 10MG INDIA

SODIUM STIBOGLUCONATE 100MG/ML INDIA

PREDNISOLONE ACETATE 1%W/W ALCON (PUETRO RICO) LABORATORIES-INC USA

BRINZOLAMIDE + TIMOLOL BELGIUM

NATURAL TEARS 15ML BELGIUM

OLOPATADINE HYDROCHLORIDE 0.1%W/V BELGIUM

PILOCARPINE 2%W/V BELGIUM

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

SILDENAFIL CITRATE + DAPOXETINE HYDROCHLORIDE

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE

100MG+325MG+15MG

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM

AKUMS DRUGS AND PHARMACEUTICALS LTD-PLANT-1 PLOT NO.19, 20&21 SECTOR-6A, 11E, SIDCUL, RAHIPUR DISTT; HARIDWAR, 249403, (UTTRAKHAND) INDIA

ALBERT DAVID LTD .-15-CHITTARANJAN AVE. KOLKATA

UNITED STATES

10MG/ML + 5MG/ML

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

Page 402: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TOBRAMYCIN 0.3%W/V BELGIUM

TRAVOPROST 4µG/ML BELGIUM

BETAXOLOL O.5%W/V BELGIUM

ATROPINE SULPHATE 1%W/V BELGIUM

TIMOLOL MALEATE 0.5% W/V SPAIN

SODIUM CROMOGLYCATE 4 %W/V SPAIN

ERYTHROMYCIN 0.5%W/W SPAIN

CEFPODOXIME PROXETIL 200MG INDIA

CEFUROXIME AXETIL 250MG INDIA

CEFIXIME 50MG/5ML INDIA

CEFIXIME 200MG INDIA

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON COUVREUR NV-RIJKSWEG 14, B-2870 PUURS BELGIUM

ALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAIN

ALCON CUSI S.A .-CAMIL FABRA,58 08320 EL MASNOU BARCELONA SPAIN

ALCON CUSI SA-CAMIL FABRA 58 08320 EL MASNOUR BARCELONA

ALKEM LABORATORIES LIMITED -VILLAGE- THANA BADDI, YEHNALAGAR, DISTRICT SOLAN, HIMACHAL PRADESH INDIA

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

Page 403: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFOPERAZONE + SULBACTAM 500 MG + 500 MG INDIA

CEFUROXIME 125MG/5ML INDIA

CEFUROXIME AXETIL 500MG INDIA

BENZYL BENZOATE 25%W/W INDIA

MEROPENEM 1G INDIA

CEFTRIAXONE 1G INDIA

PANTOPRAZOLE SODIUM 40MG INDIA

RABEPRAZOLE 20MG INDIA

CEFIXIME 400MG INDIA

CEFEPIME 1G INDIA

CEFPODOXIME PROXETIL USP 50MG / 5ML INDIA

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LIMITED.-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LTD .- VILLAGE THANA BADDI TEHSIL NALAGARH DIST SOLAN HIMACHAL PRADESH

ALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LTD .-VILLAGE THANA, BADDI, TEHSIL-NALAGARH, DISTT-SOLAN, (HP), INDIA-173205

ALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA.

ALKEM LABORATORIES LTD.-VILLAGE THANA, BADDI, DISTT. SOLAN,HIMACHAL PRADESH 173205 INDIA.

Page 404: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

250MG + 125MG INDIA

500MG + 125MG INDIA

200MG + 28.5MG INDIA

875MG + 125MG INDIA

PREGABALIN 150MG INDIA

156.25MG INDIA

200MG+ 28.5MG INDIA

PIPERACILLIN + TAZOBACTAM 4.5G INDIA

500 MG + 125 MG INDIA

AMOXICILLIN + CLAVULANIC ACID INDIA

RISEDRONATE SODIUM 35MG INDIA

875MG + 125MG INDIA

457MG/5ML INDIA

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD--167/1, VILLAGE DABHEL, AMALIYA DAMAN-396210, INDIA

ALKEM LABORATORIES LTD--167/2, MAHATMA GANDHI UDYOG NAGAR DABHEL, AMALIYA, DAMAN(UT) 396 210 INDIA

AMOXICILLIN AND CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210

AMOXICILLIN TRIHYDRATE+CLAVULANIC ACID

ALKEM LABORATORIES LTD-PLOT 167/1 VILLABE DAHBEL AMALIYA DAMAN 396210

ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.

AMOXICILLIN + POTASSIUM CLAVULANATE

ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.

200 MG + 28.5 MG/ 5 ML

ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.

ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.

AMOXICILLIN TRIHYDRATE+CLAVULANATE POTASSIUM

ALKEM LABORATORIES LTD--PLOT NO. 167/1, MAHATMA GANDHI UDYONG NAGAR, AMALIYA, DABHEL, DAMAN,396210 INDIA.

Page 405: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFUROXIME AXETIL USP 125 MG/5 ML INDIA

CEFUROXIME AXETIL USP 500 MG INDIA

CEFPODOXIME 200MG INDIA

CEFTAZIDIME 1 G INDIA

CEFUROXIME SODIUM 1.5G INDIA

CEFUROXIME SODIUM 750MG INDIA

CEFUROXIME SODIUM 750MG INDIA

ONDANSETRON 4MG/2ML INDIA

ONDANSETRON 8MG/4ML INDIA

1000MG +200MG INDIA

CIPROFLOXACIN HYDROCHLORIDE 750MG GERMANY

CIPROFLOXACIN 500MG GERMANY

AZITHROMYCIN 500MG INDIA

ALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESH

ALKEM LABORATORIES LTD--PURANA BARRIER, VILLAGE THANA, BADDI, DISTT. SOLAN, HIMACHAL PRADESH

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

ALKEM LABORATORIES LTD-VILLAGE – THANA, BADDI TEHSIL – NALAGARH, DIST-SOLAN (HP), INDIA – 173205

AMOXICILLIN SODIUM + CLAVULANATE POTASSIUM

ALKEMS LABORATORIES LIMITED-PLOT 167/1 MAHATMA GHANDHI, UDYOG NAGAR, DABHEL, AMALIYA DAMAN- 396 210UTTARANCHAL, INDIA.

ALLPHAMED PHARBIL ARZNEIMITTEL GMBH. -HILDEBRANDSTRABE 12 37081 GOTTINGEN

ALLPHARMED PHARBIL ARZNEIMITTEL GMBH-12 D377081

ALLY PHARMA OPTIONS PVT LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

Page 406: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SODIUM CHLORIDE 0.9% W/V INDIA

LINEZOLID 2MG/ML INDIA

LEVOFLOXAXIN 500MG/100ML INDIA

PARACETAMOL 10MG/ML INDIA

JORDAN

FUSIDIC ACID 1%W/V JORDAN

TIMOLOL MALEATE 0.5%W/V JORDAN

SODIUM CROMOGLYCATE 2%W/V JORDAN

PREDNISOLONE ACETATE 0.12%W/V JORDAN

ATROPINE 1%W/V JORDAN

GENTAMYCIN SULPHATE 0.3%W/V JORDAN

NORFLOXACIN 0.3%W/V JORDAN

NEOMYCIN +DEXAMETHASONE JORDAN

ALTHEA PHARMA PVT LTD --PLOT NO. 374 SHED NO. E,.ALPHA INDUSTRIAL PARK ,ATHIYAWAD DABHEL ,NANI DAMAN (U.T) 396210, INDIA

AMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT

AMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT

AMANTA HEALTHCARE LIMITED-PLOT NO. 876 N.H. NO. 8 VILLAGE-HIRIYALA TALUKA, MATAR, DIST KHEDA-387 411, GUJARAT

PREDNISOLONE ACETATE + NEOMYCIN SULPHATE+ POLYMYXIN-B

5MG/ML +5MG/ML + 1M I.U/ML

AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES .-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

0.5%W/V + 0.1%W/V

AMMAN PHARMACEUTICALS INDUSTRIES-AMMAN PHARMACEUTICAL INDUSTRIES-KING ABDULLAH II, INDUSTRIAL ESTATE,SAHAB, AMMAN, JORDAN

Page 407: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT N/A EGYPT

120MG + 5MG EGYPT

TERBINAFINE HCL 250MG EGYPT

TERBINAFINE HYDROCHLORIDE 1%W/W EGYPT

TRANEXAMIC ACID 500MG/5ML EGYPT

EGYPT

EGYPT

SECNIDAZOLE 500MG EGYPT

TRANEXAMIC ACID 500 MG EGYPT

2 GM+0.1 GM EGYPT

LORATADINE 5MG/5ML EGYPT

AMOUN PHARMACETICAL COMPANY-1ST INDUSTRIAL ZONE, EL OBOUR CITY, CAIRO, EGYPT

PSEUDOEPHEDRINE HCL+ LORATIDINE

AMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT

AMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT

AMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT

AMOUN PHARMACEUTICAL CO. S.A.E-1ST INDUSTRIAL ZONE A, PLOTS NO. 1B,2,3,4,5 BLOCK 13015, EL-OBOUR CITY, KALYOUBIA CAIRO EGYPT

BENZOCAINE+BENZYDAMINE+CATALKONIUM CHLORIDE

1.5%W/V+0.15%W/V+0.0413%W/V

AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.

NEOMYCIN + TRIAMCINOLONE ACETONIDE + GRAMICIDIN

0.25GM + 0.1G + 100000IU + 0.025G/100G

AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.

AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.

AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.

LIDOCAINE HCL+CETYL PYRIDINUM CHLORIDE

AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.

AMOUN PHARMACEUTICALS CO. S.A.E-1ST INDUSTRIAL ZONE, EL-OBOUR CITY, EGYPT.

Page 408: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EGYPT

EGYPT

NIFUROXAZIDE 200MG EGYPT

AZITHROMYCIN 500 MG EGYPT

AZITHROMYCIN 200MG/5ML EGYPT

NIFUROXAZIDE 220MG/5ML EGYPT

EGYPT

GENTAMYCIN 80MG/2ML CHINA

ARTEMETHER 80MG/ML CHINA

CHINA

DICLOFENAC 75MG/3ML CHINA

PHOLCODINE+EPHEDRINE HCL +CARBINOXAMINE MALEATE

4MG+7MG+2MG /5ML

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT

HYPERTONIC SOLUTION OF SODIUM PHOSPHATES

6GM AND 16GM/100ML

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY CAIRO EGYPT

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE EL OBOUR CITY, CAIRO EGYPT

CHLORPHENARIMINE MALEATE/DEXAMETHASONE

2MG/5ML + 0.5MG/5ML

AMOUN PHARMACEUTICALS COMPANY-1ST INDUSTRIAL ZONE,EL OBOUR CITY, CAIRO, EGYPT

ANHUI CHENGSHI MANUFACTURE MEDICINE CO LTD-NEW INDUSTRIAL ZONE BENGBU CITY ANHUI PROVINCE

ANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINA

VIT B1 + VIT B2 + VIT B6 + NICOTINAMIDE + CALCIUM DEXTROPANTOTHENATE

20MG + 2MG + 2MG + 30MG + 1MG /2ML

ANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINA

ANHUI CHENGSHI MEDICINE MANUFACTURE CO. LTD-INDUSTRIAL AREA, BENGBU CITY, ANHUI PROVINCE, CHINA

Page 409: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AZITHROMYCIN 250MG JORDAN

AZITHROMYCIN 200MG/5ML JORDAN

TELMISARTAN 40MG INDIA

INDIA

TRANEXAMIC ACID 500MG/5ML INDIA

ACECLOFENAC+PARACETAMOL 100MG+500MG INDIA

CALCIUM + COLECALCIFEROL 250MG + 125 IU INDIA

PIOGLITAZONE + METFORMIN 15 MG + 500 MG INDIA

40MG/12.5MG INDIA

20MG+10MG INDIA

ASPIRIN 75MG INDIA

ARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES,-SAHAB, JORDAN

ARAB PHARMACEUTICAL MANUFACTURING INDUSTRIES,-SAHAB, JORDAN

ARISTO PHAMACUTLAB PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.2 MANIDIDEEP 462.046

ALGINIC ACID + MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE + SIMETHICONE

100 MG + 250 MG + 125 MG + 50 MG

ARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH

ARISTO PHARMACEUTCALS PVT LTD-PLOT NO.208 NEW INDUSTRIAL AREA NO.II MANDIDEEP 462046 RAISEN MADHYA PRADESH

ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA

ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA

ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA

TELMISARTAN/HYDROCHLOROTHIAZIDE

ARISTO PHARMACEUTICALS PVT LIMITED-PLOT 208, NEW INDUSTRIAL AREA NO II, MANDIDEEP-462 046 (DISTRICT) RAISEN, MADHYA PRADESH INDIA

PANTOPRAZOLE SODIUM SESQUIHYDRATE + DOMPERIDONE CAPSULES

ARISTO PHARMACEUTICALS PVT LTD .-MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN HIMACHAL PRADESH

ARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046

Page 410: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PIOGLITAZONE HCL 30MG INDIA

ACECLOFENAC 100MG INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

AMLODIPINE BESILATE 5MG INDIA

AMLODIPINE BESILATE 2.5 MG INDIA

FEXOFENADINE HYDROCHLORIDE 120MG INDIA

FEXOFENADINE 180MG INDIA

1MG+15MG+500MG INDIA

2MG+15MG+500MG INDIA

ORNIDAZOLE + OFLOXACIN 500MG + 200MG INDIA

INDIA

ARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046

ARISTO PHARMACEUTICALS PVT LTD -PLOT NO 208 NEW INDUSTRIAL GREEN NO2 MANDIDEED 462046

ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP

ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP

ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP

ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP

ARISTO PHARMACEUTICALS PVT LTD-PLOT NO 208 NEW INDUSTRIAL AREA N0 11 MANDIDEEP

GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE

ARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205

GLIMEPIRIDE+PIOGLITAZONE+METFORMIN HYDROCHLORIDE

ARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205

ARISTO PHARMACEUTICALS PVT LTD---VILLAGE MAKHNUMAJRA P.O BHUD BADDI DISTRICT SOLAN (H.P) 173205

ACECLOFENAC+PARACETAMOL+SERRATIOPEPTIDASE

100MG + 500MG + 15MG

ARISTO PHARMACEUTICALS PVT LTD-VILLAGE: MAKHNUMAJRA P.O. BHUD BADDI DISTRIC: SOLAN (H.P) 173205

Page 411: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DIASTASE+PEPSIN 50MG+10MG INDIA

INDIA

ORNIDAZOLE 500MG INDIA

80MG +12.5 MG INDIA

LOSARTAN + AMLODIPINE 50MG + 5MG INDIA

AMBROXOL HYDROCHLORIDE 7.5MG/ML INDIA

500MG,500MG INDIA

AMBROXOL HYDROCHLORIDE 30MG/5ML INDIA

AMBROXOL HYDROCHLORIDE 30MG INDIA

TELMISARTAN 80MG INDIA

CARVEDILOL 6.25MG GERMANY

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA.

IBUPROFEN + PARACETAMOL + CHLORZOXAZONE

400MG + 325MG + 250MG

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA.

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA.

TELMISARTAN +HYDROCHLOROTHIAZIDE

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA.

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO. II, MANDIDEEP-462046, DIST. - RAISEN, MADHYA PRADESH, INDIA.

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH

METORMIN HYDROCHLORIDE ,METFORMIN HYDROCHLORIDE

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH

ARISTO PHARMACEUTICALS PVT. LIMITED-PLOT NO. 208, NEW INDUSTRIAL AREA NO.II,MANDIDEEEP PRADESH

ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY

Page 412: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CARVEDILOL 25MG GERMANY

CLOPIDOGREL BESYLATE 75MG GERMANY

ATENOLOL 50MG GERMANY

METRONIDAZOLE 200MG INDIA

SILDENAFIL 50MG INDIA

MAGNESIUM TRISILICATE 370MG INDIA

CO-TRIMOXAZOLE 480MG INDIA

CIMETIDINE 200MG INDIA

NYSTATIN 100,000IU INDIA

ACICLOVIR 200MG INDIA

FOLIC ACID 5MG INDIA

ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY

ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY

ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY

ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA382220 BAVIAAHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA382220 BAVIAAHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA382220 BAVIAAHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA382220 BAVIAAHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LIMITED-57/P RAJODA382220 BAVIAAHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA

Page 413: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIPROFLOXACIN 500MG INDIA

SILDENAFIL CITRATE 100MG INDIA

MEBENDAZOLE 100MG INDIA

PROMETHAZINE HYDROCHLORIDE 25MG INDIA

ALBENDAZOLE 400MG INDIA

AMLODIPINE 5MG INDIA

AMLODIPINE 10MG INDIA

FUROSEMIDE 40MG INDIA

METFORMIN HYDROCHLORIDE 500MG INDIA

PHENOXYMETHYL PENICILLIN 250MG INDIA

ROSUVASTATIN CALCIUM 20MG INDIA

ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT LTD-57/P,RAJODA 382220, BAVLA AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, RAJODA-382220, BAVLA AHMEDABAD, INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220,TALUKA BAVLA DIST AHMEDABAD, INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

Page 414: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TETRACYCLINE HYDROCLORIDE 250MG INDIA

CIMETIDINE TABLETS 400 MG INDIA

AZITHROMYCIN 500MG INDIA

PARACETAMOL + IBUPROFEN 500MG + 400MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

TRAMADOL 50MG INDIA

FLUCONAZOLE 150MG INDIA

FLUCONAZOLE 200MG INDIA

IBUPROFEN 200MG INDIA

GRISEOFULVIN 500MG INDIA

ERYTHROMYCIN 250MG INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

Page 415: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXYCILLIN 250MG INDIA

AZITHROMYCIN 250MG INDIA

ATORVASTATIN 20MG INDIA

AMPICILLIN 250MG INDIA

PARACETAMOL + CAFFEINE 650MG + 50MG INDIA

BISACODYL 5MG INDIA

160MG/800MG INDIA

HYOSCINE BUTYLBROMIDE 10MG INDIA

ATORVASTATIN 20MG INDIA

CARBAMAZEPINE 200MG INDIA

LORATADINE 10MG INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

TRIMETHOPRIM/SULFAMETHOXAZOLE

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT.LTD-PLOT NO. 57/P, SARKHEJ-BAVLA HIGHWAY, POST RAJODA-382220, TALUKA BAVLA, AHMEDABAD INDIA

ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.

ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.

ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.

Page 416: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METOCLOPRAMIDE 10MG INDIA

ROSUVASTATIN 10MG INDIA

AMOXICILLIN 500MG INDIA

PREDNISOLONE 5MG INDIA

NORFLOXACIN 400MG INDIA

TINIDAZOLE 500MG INDIA

CHLORPHENIRAMINE 4MG INDIA

DOXYCYCLINE 100MG INDIA

DOXYCYCLINE 100MG INDIA

DICLOFENAC SODIUM 50MG INDIA

PARACETAMOL 500MG INDIA

ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.

ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.

ASTRA LIFE CARE (INDIA) PVT-SURVEY NO.57/P, SARKHEJ-BAVLA HIGHWAY, POST- RAJOD-382220, TALUKA-BAVLA, DIST-AHMEDABAD.

ASTRA LIFE CARE PVT LTD-57/P RAJODA-382220 BAVIA AHMEDABAD INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

Page 417: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GLIBENCLAMIDE 5MG INDIA

ALBENDAZOLE 200MG INDIA

CHLORAMPHENICOL 250MG INDIA

DEXAMETHASONE 0.5MG INDIA

KETOCONAZOLE 200MG INDIA

PIROXICAM 20MG INDIA

LEVOFLOXACIN 500MG INDIA

QUININE SULPHATE BP 300MG INDIA

INDIA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

ATENOLOL 50MG INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, 382220, BOVIA, AHMEDOBAD, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-57/P, POJODA, SARKEJ BAVLA HIGHWAY RAJODA AHMEDABAD 382220, INDIA

ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD

ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD

ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD

ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD

ASTRA LIFE CARE(INDIA) PVT LTD-PLOT NO. 57/P, SARKHEJ – BAVLA HIGHWAY, POST. RAJODA – 382220, TALUKA: BAVLA, DIST. AHMEDABAD

PYRIDINE-3-CARBOXAMIDE/ RIBOFLAVIN/ THIAMINE NITRATE

17.25MG/ 1.3MG/ 1.3MG

ASTRA LIFECARE (INDIA) PVT. LTD. -PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

Page 418: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ATENOLOL 100MG INDIA

DAPSONE 100MG INDIA

DICYCLOMINE HCL + PARACETAMOL 20MG+500MG INDIA

METHYLDOPA 250MG INDIA

SALBUTAMOL 4MG INDIA

LOPERAMIDE HYDROCHLORIDE 2MG INDIA

OMEPRAZOLE 20 MG INDIA

CANDESARTAN 8MG SWEDEN

16 MG + 12.5 MG

METOPROLOL 25MG SWEDEN

METOPROLOL 50MG SWEDEN

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE (INDIA) PVT. LTD-PLOT 57/P, SARKHEJ-BAVLA HIGHWAY, RAJODA 382 220, AHMEDABAD, INDIA

ASTRA LIFECARE PVT LTD-57/P RAJODA 382220 BAVLA AHMEDABAD

ASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE

CANDESARTAN + HYDROCHLOROTHIAZIDE

ASTRA ZENECA AB, SODERTALJE-GARTUNAYEGEN, SODERTALJE

UNITED KINGDOM

ASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN

ASTRA ZENECA AB-GARTUNAVGEN SE 151 58 SODAERTAJJE SWEDEN

Page 419: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TICAGRELOR 90MG

METOPROLOL 100MG SWEDEN

CANDESARTAN CILEXETIL 16MG SWEDEN

10MG SWEDEN

BUDESONIDE 0.25MG/ML SWEDEN

BUDESONIDE 0.5MG/ML SWEDEN

CANDESARTAN 32MG SWEDEN

GOSERELIN 3.6MG

GOSERELIN ACETATE 10.8MG

BICALUTAMIDE 50MG

ATENOLOL + CHLORTHALIDONE 100 MG + 25 MG

ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)

UNITED KINGDOM

ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)

ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)

ESOMEPRAZOLE (AS MAGNESIUM TRIHYDRATE)

ASTRA ZENECA AB-SE-151 85 SODERTALJE, SWEDEN (GARTUNAVAGEN & SNACKVIKEN)

ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN

ASTRA ZENECA SWEDEN OPERATIONS LIQUID PRODUCTION -KVARNBERGAGATANLZ SE-151-85,SWEDEN

ASTRA ZENECA SWEDEN OPERATIONS-TABLET PRODUCTION SE-151 85, GARTUNAVAGEN, SODERTALJE

ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,,BULK CORDEN PHARMA GMBH-OTT HAHN STRASSE ,68723GERMANY

UNITED KINGDOM

ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

Page 420: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ATENOLOL + CHLORTHALIDONE 50 MG + 12.5 MG

ATENOLOL 100MG

ATENOLOL 50MG

ESOMEPRAZOLE 40MG/5ML SWEDEN

FELODIPINE 5MG SWEDEN

FELODIPINE 10MG SWEDEN

BUDESONIDE+FORMOTEROL SWEDEN

BUDESONIDE 200MCG SWEDEN

BUDESONIDE+FORMOTEROL SWEDEN

ESOMEPRAZOLE 20MG SWEDEN

ESOMEPRAZOLE 40MG SWEDEN

ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ASTRA ZENECA UK LIMITED-SILK ROAD BUSINESS PARK,MACCLESFIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ASTRA ZENECA--KVARNBERGAGATAN12, SE-151 SODERTALIJE

ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM

ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM

80MCG+4.5MCG/DOSE

ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM

ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM

160MCG+4.5MCG/DOSE

ASTRAZENECA AB,-GARTUNA & SNACKVIKEN STOCKHOLM

ASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLM

ASTRAZENECA AB.-GARTUNA & SNACKVIKEN STOCKHOLM

Page 421: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

20MG/12.5MG ASTRAZENECA MACCLESFIELD-CHESHIRE

BICALUTAMIDE 150MG ASTRAZENECA MACCLESFIELD-CHESHIRE

SAXAGLIPTIN + METFORMIN 5MG + 1000MG

SAXAGLIPTIN + METFORMIN 2.5MG + 1000MG

LISINOPRIL 20MG

LISINOPRIL 10MG

LISINOPRIL 5MG

ANASTROZOLE 1MG

TAMOXIFEN 10MG

TAMOXIFEN 20MG

BETAMETHASONE VALERATE 0.1%W/W PAKISTAN

LISINOPRIL/HYDROCHLOROTHIAZIDE

UNITED KINGDOM

UNITED KINGDOM

ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.

UNITED STATES

ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.

UNITED STATES

ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-CHESHIRE

UNITED KINGDOM

ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOM

UNITED KINGDOM

ASTRAZENECA PHARMACEUTICALS LP -HUANGSHAN ROAD, WUXI 214028, JIANGSU, CHINA.,ASTRAZENECA MACCLESFIELD-UNITED KINGDOM

UNITED KINGDOM

ASTRAZENECA PHARMACEUTICALS LP-NEWARK, DELAWARE

UNITED STATES

ASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ASTRAZENECA UK LIMITED -ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,

UNITED KINGDOM

ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN

Page 422: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BETAMETHASONE + NEOMYCIN 0.1%W/V+0.5%W/V PAKISTAN

PAKISTAN

BETAMETHASONE VALERATE 0.1%W/W PAKISTAN

INDIA

OLANZAPINE 5MG INDIA

OLANZAPINE 10MG INDIA

MOXIFLOXACIN HYDROCHLORIDE 400MG INDIA

METFORMIN HYDROCHLORIDE 1000MG INDIA

PANTOPRAZOLE 20MG INDIA

ABACAVIR SULPHATE 300MG INDIA

SUMATRIPTAN SUCCINATE 100MG INDIA

ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN

BETAMETHASONE VALERATE + NEOMYCIN

0.1%W/W + 0.5%W/W

ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN

ATCO LABORATORIES PVT LTD-B-18,S.I.T.E KARACHI 75700, PAKISTAN

EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMERATE

600MG + 300MG + 300MG

AUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (SEZ, UNIT – VII), -SURVEY NO.411, 425, 434, 435 & 458, APIIC, PLOT NO. SI GREEN INDUSTRIAL PARK, POLEPALLY VILLAGE, JEDCHERLA MANDAL, MAHABOOB NAGAR DISTRICT, HYDERABAD, ANDHRA PRADESH 500090, INDIAAUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.

Page 423: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EFAVIRENZ 50MG INDIA

EFAVIRENZ 200MG INDIA

EFAVIRENZ 600MG INDIA

LOPINAVIR + RITONAVIR 100MG + 25MG INDIA

CLOXACILLIN 250MG INDIA

BETAHISTINE DIHYDROCHLORIDE 24MG INDIA

CEFPODOXIME 200MG INDIA

CEFUROXIME AXETIL 500MG INDIA

CEFUROXIME AXETIL 250MG INDIA

CEFADROXIL 250 MG INDIA

CEFADROXIL 500MG INDIA

AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.

AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.

AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.

AUROBINDO PHARMA LIMITED (UNIT III) -AURO HOUSE, 313, BUCHUPALLY, QUTHUBULLAPAR(M), RR DISTRICT HYDERABAD-500090, ANDHERA PRADESH, INDIA.

AUROBINDO PHARMA LIMITED UNIT -SURVEY NO. 314, BACHUPALLY, QUTHUBULLAPUR (MANDAL), R.R - DISTRICT, HYDERABAD – 500 072, AP – INDIA

AUROBINDO PHARMA LIMITED, UNIT – III-SURVEY NO.:113 & 314,BACHUPALLY (VILLAGE)QUTHUBULLAPUR MANDAL, RANGA REDDY DISTRICT, TELANGANA STATE.INDIA.

AUROBINDO PHARMA LTD (UNIT VI) ,.,.,-SURVEY NOS. 329/39 & 329/47, CHITKUL VILLAGE, PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH

AUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH

AUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH

AUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH

AUROBINDO PHARMA LTD (UNIT VI) ,-SURVEY NOS. 329/39 & 329/47,CHITKUL VILLAGE,PATANCHERU MANDAL, MEDAK DISTRICT PIN CODE 502307, ANDHRA PRADESH

Page 424: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ZIDOVUDINE 100MG INDIA

ZIDOVUDINE 50MG/5ML INDIA

BISOPROLOL FUMARATE 2.5MG INDIA

ALFUZOSIN HYDROCHLORIDE 2.5MG INDIA

200MG/300MG INDIA

LAMIVUDINE 150 MG INDIA

LEVOFLOXACIN 500MG INDIA

4MG INDIA

MONTELUKAST SODIUM 5MG INDIA

ZIDOVUDINE 100MG INDIA

INDIA

AUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHU

AUROBINDO PHARMA LTD .-UNIT III SURVEY NO.313 BACHU

AUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)

AUROBINDO PHARMA LTD UNIT III.-SURVEY NO.313 BACHUPALL VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)

EMTRICITABINE/TENOFOVIR DISOPROXIL FUMERATE

AUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)

AUROBINDO PHARMA LTD UNIT III-AUROBINDO PHARMA LTD UNIT III SURVEY NO. 313 BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT (A.P)

AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH

MONTELUKAST CHEWABLE TABLETS 4 MG

AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH

AUROBINDO PHARMA LTD UNIT VII (SEZ) APIIC-PLOT NO. S1 SURVEY NO. 411,425,434,435 & 458 GREEN INDUSTRIAL PARK POLEPALLY VILLAGE MAHABOOBNAGAR DISTRICT ANDHRA PRADESH

AUROBINDO PHARMA LTD --UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESH

LAMIVUDINE+ZIDOVUDINE+NEVIRAPINE

150MG+300MG+200MG

AUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302

Page 425: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

INDIA

EFAVIRENZ 50MG INDIA

156.25MG/5ML INDIA

250 MG + 125 MG INDIA

500 MG + 125 MG INDIA

250+62.50MG/ 5ML INDIA

NEVIRAPINE 50MG/5ML INDIA

ABACAVIR SULPHATE 20MG/ML INDIA

NEVIRAPINE 50MG INDIA

TENOFOVIR DISOPROXIL FUMARATE 300MG INDIA

EFAVIRENZ + EMITRICITABINE + TENOFOVIR DISOPROXIL FUMARATE

600MG +200MG + 300MG

AUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

150MG + 300MG + 200MG

AUROBINDO PHARMA LTD UNIT VII-SEZ SURVEY NO. 411/P,425/P, 434/P, 435/P AND 458/P PLOT NO S1 ( PART) SPECIAL ECONOMIC ZONE GREEN INDUSTRIAL PARK POLEPALLY VILLAGRE ANDHRA PRADESH 509302

AUROBINDO PHARMA LTD UNIT VII---UNIT VII PLOT NO. S1 GREEN INDUSTRIAL PARK POLLEPALLY VILLAGE ANDHRA PRADESH

AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNALATE

AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH

AMOXICILLIN + CLAVULANATE POTASSIUM

AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH

AMOXICILLIN + CLAVULANATE POTASSIUM

AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH

CO-AMOXICLAV (AMOXYCILLIN TRIHYDRATE+POTASSIUM CLAVUNATE)

AUROBINDO PHARMA LTD, UNIT XII,.-SURVEY NO 314, BACHUPALLY VILLAGE, QUTHUBULLAPAR, R.R DISTRICT .A. PRADESH

AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA

AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA

AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA

AUROBINDO PHARMA LTD-UNIT III SURVEY NO 313& 314, BACHUPALLY (V),QUTHUBULLAPUR (M), RANGA REDDY (DIST) TELANGANA STATE,INDIA

Page 426: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

NEVIRAPINE 200MG INDIA

LAMIVUDINE 150MG INDIA

ZIDOVUDINE 300MG INDIA

LOPINAVIR/ RITONAVIR 200MG/ 50MG INDIA

ABACAVIR SULPHATE 300MG INDIA

DIDANOSINE DELAYED RELEASE 250MG INDIA

DIDANOSINE DELAYED-RELEASE 400MG INDIA

CEFPROZIL 500MG INDIA

CEFPROZIL 250 MG INDIA

CEFTRIAXONE 1000MG INDIA

LAMUVIDINE+ZIDOVUDINE + EFAVIRENZ

150MG+300MG+600MG

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT III-SURVEY NO.313,BACHUPALLY VILLAGE,QUTHUBULLAPUR MANDAL R.R DISTRICT(A.P),INDIA

AUROBINDO PHARMA LTD-UNIT VI SY.NO.329/39 & 329/47 CHITKUL VILLAG,PATARICHEM,MANDAT MEDAK DISTRICT,ANDRA PRADESH,INDIA

AUROBINDO PHARMA LTD-UNIT VI SY.NO.329/39 & 329/47 CHITKUL VILLAG,PATARICHEM,MANDAT MEDAK DISTRICT,ANDRA PRADESH,INDIA

AUROBINDO PHARMA LTD-UNIT VI, SY. NO 329/39, 329/

Page 427: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

300MG+300MG INDIA

RABEPRAZOLE SODIUM 20 MG INDIA

ZIDOVUDINE 300MG INDIA

CLOPIDOGREL 75MG INDIA

8MG INDIA

LAMIVUDINE + ZIDOVUDINE 150MG+300MG INDIA

40MG INDIA

FUSIDIC ACID 2.0 % W/W INDIA

INDIA

INDIA

LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE

AUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR

AUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR

AUROBINDO PHARMA LTD-UNIT VII (SEZ), PLOT NO.S1, GREEN INDUSTRIAL PARK, POLEPALLY (V) JEDCHERIA (M), MAHABOOB NAGAR

AUROBINDO PHARMA LTD--UNIT VII SEZ PLOT S1 SPECIAL ECONOMIC ZONE

ONDANSETRON HYDROCHLORIDE DIHYDRATE

AUROBINDO PHARMA LTD--UNIT-III SURVEY NO. 313 & 314, BACHUPALLY VILLAGE QUTHUBULLAPUR MANDAL RANGA REDDY DISTRICT TELANGANA STATE INDIA

AUROBINDOPHARMA LIMITED,-SURVEY NO. 313 & 314, BACHUPALLY VILLAGE, QUTHUBULLAPUR MANDAL, HYDERABAD,RANGA REDDY (DT),ANDHRA PRADESH - 500090INDIA.

PANTOPRAZOLE SODIUM SESQUIHYDRATE

AUROBINDOPHARMA LIMITED,-UNIT VII, SEZ APIIC, PLOT NO.SI SURVEY NO’S 425, 434,435 & 458 GREEN INDUSTRIAL PARK, POLEPALLY VILLAGEJEDCHERTA MANDAL, MAHABOOBNAGAR DISTTRICT, ANDRA PRADESH, INDIA.AUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE

FUSIDIC ACID +HYDROCORTISONE ACETATE

2.0 % W/W+1.0 % W/W

AUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE

KETOPROFEN + CAPSICUM OLEORESIN

2.50%W/W + 0.25%W/W

AUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE

Page 428: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

LACTULOSE 10G/15ML INDIA

500MG + 250MG INDIA

INDIA

INDIA

INDIA

2%W/V INDIA

0.3W/V + 0.5%W/V INDIA

LATANOPROST 0.005%W/V INDIA

CROMOLYN SODIUM 2%W/V INDIA

GATIFLOXACIN SESQUIHYDRATE 0.3%W/V INDIA

FUSIDIC ACID BP AND BETAMETHASONE VALERATE BP

2.0%W/W+0.1%W/W

AUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE

AUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE

TRANEXAMIC ACID + MEFENAMIC ACID

AUROCHEM LABORATORIES (I) PVT LTD--8 PALGHAR TALUKA INDUSTRIAL CO-OP ESTATE LTD PALGHAR 401 404 DIST THANE

BETAMETHASONE DIPROPIONATE + GENTAMICIN SULFATE + CLOTRIMAZOLE

0.64 MG/1 G + 0.1 MG/1 G + 10 MG/1 G

AUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIA

CLINDAMYCIN PHOSPHATE + TRETINOIN

1.0%W/W + 0.025%W/W

AUROCHEM LABORATORIES LTD -PLOT 08 PALGHAR 401404 MAHARASHTRA, INDIA

PARACETAMOL+ DICLOFENAC POTASSIUM+CHLORZOXAZONE

500 MG+50 MG+250 MG

AUROCHEM PHARMACEUTICALS (I) PVT.LTD.-58, PALGHAR TALUKA,INDUSTRIAL CO.-OP. ESTATE LTD.PALGHAR –INDIA

HYPROMELLOSE OPHTHALMIC SOLUTION USP

AUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA

OFLOXACIN + PREDNISOLONE SODIUM PHOSPHATE

AUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA

AUROLAB.-SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI 625 020 TAMIL INDIA

AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA

AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA

Page 429: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PREDNISOLONE ACETATE 1%W/V INDIA

CHLORAMPHENICOL 0.5%W/V INDIA

TIMOLOL MALEATE 0.5% W/V INDIA

MEROPENEM 500MG INDIA

ERTAPENEM SODIUM 1 G INDIA

IMIPENEM+CILASTATIN 500MG +500MG INDIA

MEROPENEM 1000MG INDIA

METRONIDAZOLE 0.5%W/V INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG/100ML INDIA

CIPROFLOXACIN 200MG/100ML INDIA

CIPROFLOXACIN HYDROCHLORIDE 0.3% W/V INDIA

AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA

AUROLAB-NO 1 SIVAGANGAI MAIN ROAD, VEERAPANJAN MADURAI – 625 020 TAMIL NADU, INDIA

AUROLAB-NO. 1, SIVAGANGAI MAIN ROAD, VEERAPANJAN, MADURAI

AURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.

AURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.

AURONEXT PHARMA PRIVATE LIMITED,-A-1128, RIICO INDUSTRIAL AREA, PHASE-III,BHIWADI-301019, DISTRICT- ALWAR (RAJASTHAN), INDIA.

AURONEXT PHARMA PVT LTD.-A- 1128 RIICO INDUSTRIAL AREA, PHASE III, DISTALWAR, BHIWADI

AXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR(UTTARAKHAND) INDIA.

AXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR(UTTARAKHAND) INDIA.

AXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR(UTTARAKHAND) INDIA.

AXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR(UTTARAKHAND) INDIA.

Page 430: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PARACETAMOL 10MG/ML INDIA

MOXIFLOXACIN HYDROCHLORIDE 0.5%W/V INDIA

CEFUROXIME AXETIL 500MG INDIA

CEFUROXIME AXETIL 250MG INDIA

BAYER AG -D-51368 LEVERKUSEN GERMANY GERMANY

BIFONAZOLE 10MG BAYER AG-D-51368 LEVERKUSEN GERMANY GERMANY

NIFEDIPINE 30MG BAYER AG-D-51368 LEVERKUSEN GERMANY GERMANY

NIFEDIPINE 20MG BAYER AG-D-51368 LEVERKUSEN GERMANY GERMANY

1.3MG/ 1MG ITALY

0.001 ITALY

1.9MG/G & 5MG/G ITALY

AXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR(UTTARAKHAND) INDIA.

AXA PARENTERAL LIMITED-PLOT NO.936,937&939,VILL. KISHANPUR, JAMALPUR,ROORKEE 247667, DISTT. HARIDWAR(UTTARAKHAND) INDIA.

BAROQUE PHARMACEUTICALS PVT LTD -192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA

BAROQUE PHARMACEUTICALS PVT LTD -192/2&3, SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIA

ACETYL SALICYLIC ACID + SODIUM HYDROGEN CARBONATE + CITRIC ACID

342 MG + 1625 MG + 965 MG

PREDNISOLONE CAPROATE/ CINCHOCAINE HYDROCHLORIDE

BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY

METHYL PREDNISOLONE ACEPONATE

BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY

PREDNISOLONE CAPROATE/ CINCHOCAINE HCL

BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY

Page 431: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

0.1% + 1% W/W ITALY

0.1%W/W GERMANY

ISOCONAZOLE NITRATE 1%W/W ITALY

RIVAROXABAN 10MG BAYER HEALTHCARE AG,-D-51368, LEVERKUSEN GERMANY

MESTEROLONE 25MG GERMANY

NORETHISTERONE ENANTATE 200MG GERMANY

PRAZIQUANTEL 600MG GERMANY

NIMODIPINE 30MG GERMANY

VARDENAFIL HCL 5MG GERMANY

10 MG GERMANY

VARDENAFIL HCL 20 MG GERMANY

DIFLUCORTOLONE VALERATE + ISOCONAZOLE NITRATE

BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY

METHYLPREDNISOLONE ACEPONATE

BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY

BAYER HEALTH CARE MANUFACTURING S.R.I -S.P.A VIA SCHERING,21 20090 SEGRATE (MILAN) ITALY

BAYER PHARMA A.G-PRODUKTIONS KG DOBERRENSTRASSE 20 99427 WEIMAR

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

VARDENAFIL MONOHYDROCHLORIDE TRIHYDRATE

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

Page 432: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIPROFLOXACIN 2MG/ML GERMANY

CIPROFLOXACIN 750MG GERMANY

CIPROFLOXACIN 500MG GERMANY

NIMODIPINE 0.2MG/ML GERMANY

0.15MG / 0.03MG GERMANY

250MG GERMANY

NORETHISTERONE 5MG GERMANY

BIFONAZOLE 1%W/W GERMANY

RIVAROXABAN 15MG GERMANY

RIVAROXABAN 20MG GERMANY

CIPROFLOXACIN 500MG GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

LEVONORGESTREL / ETHINYLESTRADIOL.

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

HYDROXYPROGESTERONE HEXANOATE

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN

BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN

BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN

Page 433: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

RIVAROXABAN 2.5MG GERMANY

FRANCE

LEVONORGESTREL 150MG BAYER PHARMA OY-PANSLONTIE 47 20210 TURK FINLAND

LEVONORGESTREL 52MG BAYER PHARMA OY-PANSLONTIE 47 20210 TURK FINLAND

LEVONORGESTREL 0.03MG GERMANY

0.15MG + 0.03MG FRANCE

ARTEMETHER + LUMEFANTRINE 20MG + 120MG

MULTI-INGREDIENT N/A

MULTIINGREDIENT N/A

5MG + 12.5MG GERMANY

BAYER PHARMA AG 51368 LEVERKUSEN-BAYER PHARMA AG 51368 LEVERKUSEN

ETHINYL ESTRADIOL+ LEVONORGESTREL+FERROUS FUMARATE

0.03MG+0.15MG+75MG

BAYER PHARMA AG BERLIN,BAYER PHARMA AG -13353 BERLIN GERMANY,BAYER WEIMAR GMBH UND CO. KG,-WEIMAR DEBEREINERSTRASSE 20, 99427 WEIMAR GERMANY

BAYER WEIMER GMBH- DOBEREINERSTRASSE 20, D-99427 WEIMER 2.BAYER PHARMA AG 13342, BERLIN

LEVONORGESTREL + ETHINYLESTRADIOL

BAYER WEIMER GMBH- DOBEREINERSTRASSE 20, D-99427 WEIMER 2.BAYER PHARMA AG 13342, BERLIN,BAYER PHARMA AG -51368 LEVERKUSEN GERMANY

BEIJING NOVARTIS PHARMA LTD-31ST YONG'AN ROAD, CHANGPING DISTRICT, BEIJING P.R,NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY

BEIJING/TURKEY

BELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRESCHESHIRE HOUSE/GORSEY LA

UNITED KINGDOM

BELL SONS & CO (DRUGGISTS) LTD-SLAIDBURN CRESCHESHIRE HOUSE/GORSEY LA

UNITED KINGDOM

NEBIVOLOL HYDROCHLORIDE + HYDROCHLOROTHIAZIDE

BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, -) BERLIN-CHEMIE AG, SITE BRITZ (BULK PRODUCTION, BATCH CONTROL)TEMPELHOFER WEG 83 D-12347 BERLINGERMANY

Page 434: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NEBIVOLOL HYDROCHLORIDE 5MG GERMANY

IBUPROFEN 100MG/5ML KENYA

SALBUTAMOL + BROMHEXINE KENYA

MULTIINGREDIENT N/A KENYA

MULTIINGREDIENT N/A KENYA

PARACETAMOL 120MG/5ML KENYA

MULTIINGREDIENT N/A KENYA

IPECACUANHA TINCTURE 0.5ML KENYA

IPECACUANHA TINCTURE 0.5ML KENYA

PARACETAMOL 500MG KENYA

POVIDONE IODINE 0.1%W/V KENYA

BERLIN-CHEMIE AG-BERLIN-CHEMIE AG GLIENICKER WEG 125 D-12489 BERLIN

BETA HEALTH CARE INTERNATIONAL LTD-BONDO ROAD P.O BOX 42569, NAIROBI, KENYA.

2MG/5ML + 4MG/5ML

BETA HEALTH CARE INTERNATIONAL LTD-INDUSTRIAL AREA BONDO RD PLOT NO.7261/207 NAIROBI KENYA,BETA HEALTH CARE INTERNATIONAL LTD-MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYA

BETA HEALTH CARE INTERNATIONAL LTD-MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYA

BETA HEALTH CARE INTERNATIONAL LTD-MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYA

BETA HEALTH CARE INTERNATIONAL LTD-MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYA

BETA HEALTHCARE INTERNATIONAL LTD-INDUSTRIAL AREA, BONDO ROAD

BETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,

BETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,

BETA HEALTHCARE INTERNATIONAL LTD-PLOT LR 209/6554 MOGADISHU ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA NAIROBI, 00100,

BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA

Page 435: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BENZYL BENZOATE 25%W/V KENYA

ACECLOFENAC 100MG BANGLADESH

ALBENDAZOLE 400MG BANGLADESH

BECLOMETHASONE 50MCG BANGLADESH

BECLOMETHASONE DIPROPIONATE 200MCG BANGLADESH

LEVOFLOXACIN 500MG BANGLADESH

METFORMIN HYDROCHLORIDE 500MG BANGLADESH

25MCG+125MCG BANGLADESH

SALBUTAMOL BANGLADESH

SACCHAROMYCES BOULARDII 250MG INDIA

CHORIONIC GONADOTROPHIN 5000 I.U/ VIAL INDIA

CARBOPROST TROMETHAMINE 125MCG/0.5ML INDIA

300MCG INDIA

BETA HEALTHCARE INTERNATIONAL LTD--PLOT NO.209/6554,MOGADISHU ROAD,OFF LUNGA LUNGA INDUSTRIAL AREA,NAIROBI,KENYA

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESHBEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

100MCG/ACTUATION

BEXIMCO PHARMACEUTICALS LTD-TONGI- 1711, GAZIPUR, BANGLADESH

BHARAT BIOTECH INTERNATIONAL LTD-TURKPALLYSHAMEX500 078MYDERAHADINDIA

BHARAT SERUMS & VACCINES LIMITED -PLOT NO. K-27, ADDITIONAL MIDC, AMBERNATH (E) MAHARASHTRA STATE 421501

BHARAT SERUMS & VACCINES LTD.-PLOT NO. K–27, JAMBIVILI VILLAGE,ANAND NAGAR, ADDITIONAL M.I.D.C., AMBERNATH (EAST)-INDIA

ANTI RHO-D IMMUNOGLOBULIN INJECTION, MONOCLONAL

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

Page 436: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

250IU INDIA

RABIES ANTISERUM 1000IU/ 5ML INDIA

75I.U/ VIAL INDIA

ULINASTATIN 100,000 I.U INDIA

LEUPROLIDE ACETATE 3.75MG INDIA

POLYMYXIN B 500,000 UNITS INDIA

AMPHOTERICIN B 50MG INDIA

INDIA

RABEPRAZOLE SODIUM 20MG TURKEY

200MG + 28MG TURKEY

FERROUS SULPHATE+FOLIC ACID 200MG+0.4MG INDIA

FERROUS SULPHATE+FOLIC ACID 200MG+0.25MG INDIA

INSULIN HUMAN 100 IU/ML INDIA

B.GABONICA/B.ARIENTANS/ B.NASICORNIS/ DENDROASPIS/ POLYEPIS/D.ANGUSTICEPS/ N.NIVEA /N.NLGRCOLLIS/N.HAJE

25/25/20/25/25/25/25/25/20/25/20/25 I.U

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

HUMAN TETANUS IMMUNOGLOBULIN

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

RECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

BHARAT SERUMS AND VACCINES LIMITED,-PLOT NO. K-27, ADDITIONAL MIDC,AMBERNATH (EAST), INDIA

BHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501

HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU] /150 I.U

75 IU + 75 IU/ 150 I.U VIAL

BHARAT SERUMS AND VACCINES LTD- PLOT NO. K-27 ADDITIONAL MIDC AMBERNATH (E ) 412 501

BİLİM PHARMACEUTICALS-GOSB 41480 GEBZE-KOCAELİ/TURKE

AMOXYCILLIN + POTASSIUM CLAVULANATE

BILIM PHARMACEUTICALS-ISLETMESI 59501 CERKEZKOY TEKIRDAG

BIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLI

BIO NOVA PHARM LTD.-C-66/1 OKHLA INDUSTIAL AREA PHASE II NEW DEHLIBIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROAD

Page 437: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INSULIN HUMAN 100 IU/ML INDIA

INSULIN HUMAN 30/70I.U/ML INDIA

INSULIN GLARGINE 100IU/ML INDIA

4,000 IU/ML INDIA

INSULIN GLARGINE(R-DNA ORGIN) 100I.U/ML INDIA

INSULIN GLARGINE (R-DNA ORIGIN) 100I.U/ML INDIA

TRASTUZUMAB (R-DNA ORIGIN) 150MG INDIA

TRASTUZUMAB (R-DNA ORIGIN) 440MG INDIA

TETANUS VACCNE ADSORBED 40 I.U INDIA

TETANUS VACCNE ADSORBED 40 I.U INDIA

TETANUS VACCNE ADSORBED 40 I.U INDIA

BIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROAD

BIOCON LIMITED-SPECIAL ECONOMIC ZONE PLOT 204 PHASE IV BOMMASANDRA JIGANI LINK ROAD

BIOCON LIMITED-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA

RECOMBINANT HUMAN ERYTHROPOETIN ALPHA

BIOCON LIMITED-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA

BIOCON LIMITED-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA

BIOCON LIMITED-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROAD BANGALORE-560 099 INDIA

BIOCON LIMITED-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROADBANGALORE-560 099

BIOCON LIMITED-SPECIAL ECONOMIC ZONE,PLOT NO.2-4, PHASE IV, BOMMASANDRA- JIGANI LINK ROADBANGALORE-560 099

BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078

BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078

BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078

Page 438: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

HEPATITIS B VACCINE (RDNA) INDIA

INDIA

INDIA

ALBENDAZOLE 400MG INDIA

ARTEMETHER + LUMEFANTRINE 180 MG + 1080 MG INDIA

AZITHROMYCIN 250MG INDIA

AZITHROMYCIN 500MG INDIA

DIAZEPAM 5MG INDIA

DIAZEPAM 2.5MG INDIA

GLIBENCLAMIDE 5MG INDIA

GLYCERIN 1G INDIA

INDIA

PAEDIATRIC 0.5ML-1DOSE , ADULT 1ML-1 DOSE

BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078

NOSCAPINE + CHLORPHENIRAMINE MALEATE + SODIUM CITRATE + AMMONIUM CHLORIDE

7MG+2 MG+ 3.25 MG+28 MG/5 ML.

BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078

DIPHTHERIA + TETANUS + PERTUSSIS + HEPATITIS B + HAEMOPHILUS TYPE B CONJUGATE VACCINE

25LF + 5.5LF + 16 IOU + 12.5 MCG + 11MCG

BIOLOGICAL E LTD-PLOT NO.1, S.P BIOTECHNOLOGY PARK, PHASE II KOLTHER (V), SHAMEERPET(M), RANGA REDDY(DIST), ANDHRA PRADESH, INDIA 500078

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

METRONIDAZOLE+NEOMYCIN SULPHATE+NYSTATIN

500MG+65,000I.U+100,000I.U

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

Page 439: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

ARTEMETHER + LUMEFANTRINE 80 MG + 480 MG INDIA

ARTEMETHER + LUMEFANTRINE 40 MG + 240 MG INDIA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

PARACETAMOL BP 250 MG INDIA

PARACETAMOL 125MG INDIA

INDOMETHACIN 100MG INDIA

DICLOFENAC SODIUM 100MG INDIA

INDIA

METRONIDAZOLE BP 500MG INDIA

INDIA

ACECLOFENAC + PARACETAMOL 100MG + 500MG INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-NO.10 SURVEY NO. 38/1 DEWAN UDYOG NAGAR ALIYALI VILLAGE TAL. PALGHAR DIST. THANE 401404 MAHARASHTRA INDIA

BLISS GVS PHARMA LIMITED-PLOT NO. 10/11 SURVEY NO.39/1 DEWAN UDYOGNAGAR ALIYALI VILLAGE TAL PALGHARDIST. THANE 401404 MAHARASHTRAINDIA

BLISS GVS PHARMA LIMITED-PLOT NO. 10/11, SURVEY NO. 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

ZINC OXIDE+LIDOCAINE+HYDROCORTISONE+ALLANTOIN

5%W/W+3%W/W+0.25%W/W+0.5%W/W

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

VITAMIN B1 +B6+B12 WITH L-GLUTAMIC ACID

100MG+50MG+100MCG+50MG

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

Page 440: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

80MG /640MG INDIA

NONOXYNOL-9 5%W/V INDIA

PEG 150OBP/ PEG 1000BP 1280MG/ 320MG INDIA

POVIDONE IODINE 200MG INDIA

40/320MG INDIA

AZITHROMYCIN DIHYDRATE 40MG/ML INDIA

ARTESUNATE 50MG INDIA

CEFADROXIL 125MG INDIA

AMOXYCILLIN 125MG INDIA

CEFADROXIL 250MG INDIA

ALBENDAZOLE 400MG INDIA

MEFENAMIC ACID + PARACETAMOL 500MG + 450MG INDIA

250MG + 10MG INDIA

MEFENAMIC ACID 500MG INDIA

INDIA

MEFENAMIC ACID 100MG/5ML INDIA

CETIRIZINE 10 MG INDIA

DIHYDROARTEMISININ/ PIPERAQUINE PHOSPHATE

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

DIHYDROARTEMISININ/PIPERAQUINE PHOSPHATE

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS GVS PHARMA LTD-PLOT.NO 10,SURVEY NO 38/1,DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR, TAL: PALGHAR DIST.THANE, MAHARASHTRA-INDIA

BLISS INDASI LIFESCINCES PRIVATE LIMITED - -PLOT 73-76 SILVER INDUSTRIAL ESTATE, BHIMPORE, DAMAN 396 210, INDIA

BLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA

BLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA

BLUE CROSS LABORATORIES LIMITED-A-12 MIDC AMBAD-NASHIK-422010 MAHARASHTRA STATE, INDIA

BLUE CROSS LABORATORIES LTD-A-12, M.I.D.C AMBAD NASHIK-422010BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722

MEFENAMIC ACID + DICYCLOMINE HYDROCHLORIDE

BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722

CLOBETASOL + MICONAZOLE + GENTAMICIN

0.05%W/W + 2% W/W+ 0.1%W/W

BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722BLUE CROSS LABORATORIES LTD-L-17, VERNA INDUSTRIAL ESTATE,VERNA GOA-403722

Page 441: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

AMOXICILLIN TRIHYDRATE 125MG/5ML INDIA

ACICLOVIR 5%W/W INDIA

CEFIXIME TRIHYDRATE 200MG INDIA

AZITHROMYCIN DIHYDRATE 500MG INDIA

ACYCLOVIR 200MG INDIA

CIPROFLOXACIN 500MG INDIA

DICLOFENAC DIETHYLAMINE 1%W/W INDIA

DICLOFENAC SODIUM 25MG/ML INDIA

100MG INDIA

INDIA

CETIRIZINE HYDROCHLORIDE 10MG INDIA

AMOXICILLIN TRIHYDRATE 250MG INDIA

CEFALEXIN MONOHYDRATE 125MG/5ML INDIA

SAXAGLIPTIN 2.5MG

CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN HBR + PHENYLEPHRINE

2MG/5ML + 15MG/5ML + 5MG/5ML

BLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010

TERBUTALINE+BROMHEXINE+GUAIFENESIN

1.25MG+4MG+50MG/5ML

BLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK 422010BLUECROSS LABORATORIES LIMITED-A-12,M.I.D.C,NASHIK MAHARASHTRA 422010BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

HYDROCORTISONE SODIUM SUCCINATE

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

OXYTETRACYCLINE HYDROCHLORIDE +HYDROCORTISONE ACETATE+POLYMYXIN B SULPHATE

10MG+5MG+10000I.U

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRAWN LABORATORIES LTD.-13, NIT, INDUSTRIAL AREA, FARIDABAD-121001, HARYANA

BRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620USA

UNITED STATES

Page 442: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DAPAGLIFLOZIN 10MG

SAXAGLIPTIN 5MG

OFLOXACIN + ORNIDAZOLE 200MG + 500 MG INDIA

ONDANSENTRON 4MG INDIA

DICLOFENAC SODIUM 50MG INDIA

INDIA

CETIRIZINE HCL 10MG INDIA

MEBENDAZOLE 100MG INDIA

MEBENDAZOLE 100MG/5ML INDIA

IRON + FOLIC ACID + VITAMIN B12 INDIA

PARACETAMOL 125MG/5ML INDIA

OMEPRAZOLE 20MG INDIA

10MG INDIA

AZITHROMYCIN 200MG/5ML INDIA

AZITHROMYCIN 500MG INDIA

CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML INDIA

BRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620USA

UNITED STATES

BRISTOL-4601 HIGHWAY 62 EAST MOUNT VERNON INDIANA 47620USA,ASTRA ZENECA UK LIMITED-ASTRAZENECA UK LIMITED SILK ROAD BUSINESS PARK, MACCLES FIELD,CHESHIRE SK 10 2NA,

UNITED STATES

CACHET PHARMACEUTICAL PVT LTD. HIMACHAL-THANA, BADDI, HIMACHAL PRADESH-173 205,INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

PARACETAMOL/ CAFFEINE/ PHENYLEPHRINE/ CHLORPHENIRAMINE

500MG/ 30MG/ 5MG/ 2MG

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

32MG/15ML + 0.5MG/15ML + 7.5MCG/15ML

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

METOCLOPRAMIDE HYDROCHLORIDE

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

Page 443: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

IBUPROFEN 200MG INDIA

AMINOPHYLLINE 100MG INDIA

INDIA

ONDANSETRON 2MG/5ML INDIA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

PREGABALIN 75MG INDIA

ARTEMETHER / LUMEFANTRINE 80MG/ 480MG INDIA

PARACETAMOL 500MG INDIA

325MG+37.5MG INDIA

OFLOXACIN + ORNIDAZOLE INDIA

INDIA

BROMHEXIDINE HCL + SALBUTAMOL SULPHATE + GUAIPHENESIN

24MG/100ML + 42MG/100ML + 1G/ML

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CETIRIZINE HYDROCHLORIDE+DEXTROMETHORPHAN HYDROBROMIDE+ACETAMINOPHEN+PHENYLEPHRINE HYDROCHLORIDE+ZINC GLUCONATE+MENTHOL

2.5MG+7.5MG+125MG+5MG+7.5MG+2.5MG/5ML

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD -THANA BADDI 173205 DISTRICT SOLAN (HIMACHAL PRADESH) INDIA

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

ACETAMINOPHEN +TRAMADOL HYDROCHLORIDE

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

50MG + 125MG / 5ML

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

CETIRIZINE HYDROCHLORIDE + DEXTROMETHORPHAN HYDROBROMIDE + ACETAMINOPHEN + PHENYLEPHRINE HYDROCHLORIDE + ZINC GLUCONATE

5.0 MG +15 MG + 500 MG + 5 MG + 7.5 MG

CACHET PHARMACEUTICALS PVT LTD-VILLAGE AND POST THANA BADDI TEHSIL NALAGARH SOLAN DISTRICT HIMACHAL PRADESH 173 205

Page 444: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

ATORVASTATIN 10MG INDIA

MONTELUKAST 10MG INDIA

80MG/12.5MG INDIA

ATENOLOL 50MG INDIA

TRAMADOL HYDROCHLORIDE 50MG INDIA

TINIDAZOLE 500MG INDIA

GLIBENCLAMIDE 5MG INDIA

OLANZAPINE 10MG INDIA

ATORVASTATIN 40MG INDIA

ATENOLOL 100MG INDIA

NIFEDIPINE 20MG INDIA

GLYCERIN/ ZINC SULPHATE/ SODIUM MOLYBDATE/ MANGANESE CHLORIDE/ LYSINE HCL

5.0G/ 263.83MG/ 0.4035MG/ 57.66MG/ 612MG

CACHET PHARMACEUTICALSPVT.LTD.--415,SHAH NAHAR,WORLI MUMBAI

CADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOACADILA HEALTH CARE LIMITED -PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA

VALSARTAN/HYDROCHLOROTHIAZIDE

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

Page 445: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CARBAMAZEPINE 200MG INDIA

CIPROFLOXACIN 500MG INDIA

LOSARTAN POTASSIUM 25MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

ATORVASTATIN 20MG INDIA

FLUCONAZOLE 200MG INDIA

4MG/ML INDIA

DEXAMETHASONE 0.5MG INDIA

MESALAMINE DELAYED RELEASE 1.2GM INDIA

OLMESARTAN 40MG INDIA

8MG INDIA

OLMESARTAN 20MG INDIA

AMLODIPINE BESYLATE 5MG INDIA

OFLOXACIN 200MG INDIA

PIROXICAM 20MG INDIA

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..

CADILA HEALTH CARE LIMITED-KUNDAIM INDUSTRIAL ESTATE, PONDA, GOA-403401, INDIA..,S.KANT HEALTHCARE LIMITED--PLOT NO. 1802-1805,GIDC PHASE II-396195,DIST.VALSAD,GUJARAT,INDIA

CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTH CARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIA

DEXAMETHASONE DISODIUM PHOSPHATE

CADILA HEALTH CARE LTD-SARKHEJ BAVLA N.H NO. 8A MORAIJA, TAL, SANARD, AHMEDAD 382210, INDIA

CADILA HEALTHCARE LIMITED SARKHEJ-SARKHEJ-BAVLA N.H NO.8A, N.H NO.8A,

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

ONDANSETRON HYDROCHLORIDE DIHYDRATE

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

Page 446: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

50MG + 12.5MG INDIA

GLIMEPIRIDE 4MG INDIA

CELECOXIB 200MG INDIA

CELECOXIB 100MG INDIA

RANITIDINE 150MG INDIA

FILGRASTIM 300µG/ML INDIA

ACECLOFENAC 100MG INDIA

VALSARTAN 80MG INDIA

ALENDRONATE 70MG INDIA

CARVEDILOL 3.125 MG INDIA

DESLORATADINE 5MG INDIA

TRAMADOL HCL + PARACETAMOL 37.5MG+325MG INDIA

CLOPIDOGREL 75MG INDIA

GLIMEPIRIDE 2MG INDIA

SILDENAFIL 50MG INDIA

AMLODIPINE BESYLATE 10MG INDIA

SILDENAFIL 100MG INDIA

TOLPERISONE 100MG INDIA

TOLPERISONE 150MG INDIA

OMEPRAZOLE 40MG/VIAL INDIA

LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE

CADILA HEALTHCARE LIMITED--KUNDAIM INDUSTRIAL ESTATE, PLOT NO. 203-213, KUNDAIM,GOA-403 115, INDIA

CADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD -KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD SARKHEJ-BAVLA NH NO.8A MORAIYA TAL SANAND DISTRICT AHMEDABAD 382210

CADILA HEALTHCARE LTD.--PLOT SURVEY NO. 23, 25/P, 37, 40/P, 42 TO 47 SARKHEJ BAVLA N.H NO.8A OPP.RAMDEV MASALA CHANGODAR TAL. SANAND DIST AHMEDABAD 382213

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE PONDA GOA 403 401CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-KUNDAIM INDUSTRIAL ESTATE, PLOT NO.203-213, KUNDAIM GOA, 403115, INDIA

CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOACADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOACADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA

Page 447: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CARVEDILOL 12.5 MG INDIA

CARVEDILOL 6.25MG INDIA

OMEPRAZOLE 20MG INDIA

INDIA

RABIES VACCINE BP 2.5 IU INDIA

SALBUTAMOL 100CMG/DOSE INDIA

ONDANSETRON 4MG/2ML INDIA

200MCG/ 6MCG INDIA

100MCG+6MCG INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

MONTELUKAST 5MG INDIA

40MG + 12.5MG INDIA

ATORVASTATIN 20MG INDIA

TADALAFIL 20MG INDIA

CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOACADILA HEALTHCARE LTD--PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA 403401CADILA HEALTHCARE LTD-PLOT 203-213, KUNDAIM INDUSTRIAL ESTATE, GOA, S KANT HEALTHCARE LTD-PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT.

BUDESONIDE + FORMOTEROL FUMARATE

120 METERED DOSES (400MCG/6MCG)

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

BUDESONIDE + FORMOTEROL FUMARATE

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

BUDESONIDE + FORMOTEROL FUMARATE

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

CADILA HEALTHCARE LTD---SARKHEJ-PLOT 417,419,420, SARKHEJ-BAVLA NH NO.8A,VILLAGE: MORAIYA TAL: SANAND DISTRICT AHMEDABAD 382210

TELMISARTAN + HYDROCHLOROTHIAZIDE

CADILA PHARMACEUTICALS LIMITED.-1389, DHOLKA-387810, INDIA OPP.RAJVANSH APARTMENT,SATYA MARG, BODAKDEV, AHMEDABAD – 380054,GUJARAT, INDIA.

CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE

Page 448: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFALEXIN 125MG/5ML INDIA

FLUOXETINE HCL 20MG INDIA

RUPATADINE FUMERATE 10 MG INDIA

PARACETAMOL/DICYCLOMINE 500MG/20MG INDIA

ENALAPRIL 10MG INDIA

ENALAPRIL MALEATE 5MG INDIA

TRIAMCINOLONE ACETONIDE 40MG/ML INDIA

CEFOTAXIME SODIUM 1GM INDIA

CEFTRIAXONE SODIUM 1000MG INDIA

DOMPERIDONE 1MG/ML INDIA

TELMISARTAN 40MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

CEFPODOXIME PROXETIL 50MG/5ML INDIA

KETOROLAC TROMETHAMINE 30MG INDIA

RABEPRAZOLE SODIUM 20MG INDIA

CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LIMITED-1389 DHOLKA 387810 DISTRCT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD ...-1389 DHOKA GUIJARAT STATE, INDIA

CADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA – 387 810, AHMEDABAD, GUJARAT STATEINDIA

CADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA – 387 810, AHMEDABAD, GUJARAT STATEINDIA

CADILA PHARMACEUTICALS LTD DHOLKA ...-SURVEY NO. 1389, DHOLKA – 387 810, AHMEDABAD, GUJARAT STATEINDIA

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

Page 449: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

RABEPRAZOLE 20MG/VIAL INDIA

INDIA

INDIA

CEFOPERAZONE + SULBACTAM INDIA

CLOPIDOGREL 75MG INDIA

DICYCLOMINE HYDROCHLORIDE 10MG/ML INDIA

ONDANSETRON 2MG/ML INDIA

ONDANSETRON 4MG INDIA

NEBIVOLOL 5MG INDIA

1G + 1G INDIA

INDIA

DICLOFENAC POTASSIUM 50MG GERMANY

DUTASTERIDE, TAMSULOSIN 0.5MG,0.4MG GERMANY

TETRACYCLINE HYDROCHLORID 1%W/W INDIA

MICONAZOLE 20MG INDIA

INDIA

DIAZEPAM 5MG INDIA

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

FOLICACID+ VITAMIN B12+IRON AMMONIUM CITRATE

1MG+5MCG+200MG/15ML

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CHLORPHENIRAMINE/GUAIFENESIN/AMMONIUM CHLORIDE

2MG//80MG/100MG

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

604.96 MG + 570.03 MG

CADILA PHARMACEUTICALS LTD.-1389, TRASAD ROAD, DHOLKA 387810 DISTRICT AHMEDABAD GUJARAT STATE

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

SULBACTAM SODIUM + CEFOPERAZONE SODIUM

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

MYCOBACTERIUM W (HEAT KILLED) + SODIUM CHLORIDE

0.5 *10 TO POWER 9 BACILLI + 0.9%W/V

CADILA PHARMACEUTICALS LTD-1389 DHOLKA 387 810 DIST AHMEDABAD GUJARAT

CATALENT GERMANY EBERBACH GMBH..-GAMMELS BACHERSTRASSE2

CATALENT GERMANY SCHONDORF GMBH -STEINBEISSTRASSE 1-2, 73614 SCHORNDORF, GERMANY

CENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIA

CENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIA

CHOLINE SALICYLATE+LIGNOCAINE HCL+BENZALKONIUM CHL

8.7%W/W+2%W/W+0.01%W/W

CENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIA

CENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIA

Page 450: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOBETASOL 0.05%W/W INDIA

0.2%W/W / 1%W/W INDIA

MULTIINGREDIENT N/A INDIA

OXYMETAZOLINE HYDROCHLORIDE 0.025%W/V INDIA

INDIA

METOLAZONE TABLETS USP 2.5MG INDIA

METOLAZONE 5MG INDIA

BENZOYL PEROXIDE 5%W/W INDIA

2MG+275MG INDIA

MULTI INGREDIENT MULTI INGREDIENT INDIA

INDIA

INDIA

ESOMEPRAZOLE 20MG INDIA

ESOMEPRAZOLE 40MG INDIA

TETRACYCLINE HYDROCHLORIDE 1%W/W INDIA

INDIA

CENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIA

CHOLRHEXIDINE GLUCONATE/SILVER SULPHADIAZINE

CENTAUR DRUG HOUSE PVT LIMITED-PLOT 39-41 TWIM IND. EST,KARASWADA,MAPUJA,GOA 403526 INDIA

CENTAUR PHARMA PVT. LTD, PLANT I-PLOT 3, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOA

CENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA

VITAMIN B1 + VITAMIN B6 + VITAMIN B12

200MG + 50MG + 1MG

CENTAUR PHARMA PVT. LTD-PLOT 39-41, TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA GOA INDIA

CENTAUR PHARMA PVT.LIMITED-PLANT I-PLOT3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA

CENTAUR PHARMA PVT.LTD-PLANT I-PLOT 3,TIVIM INDUSTRIAL ESTATE,KARASWADA,MAPUSA GOA INDIA

CENTAUR PHARMACEUTICALS LTD- PLOT NO. 39 TIVIN IN

CYPROHEPTADINE+TRICHOLINE CITRATE

CENTAUR PHARMACEUTICALS LTD,--KARASWADA MAPUSA GOA

CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

SALBUTAMOL SULPHATE/AMBROXOL SULPHATE/GUAFENESIN/MENTHOL

2MG+30MG+100MG+5MG/10ML

CENTAUR PHARMACEUTICALS LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

PHENYLEPHRINE HYDROCHLORIDE+NAPHAZOLINE HYDROCHLORIDE+CHLORPHRENIRAMINE MALEATE+MENTHOL+CAMPHOR

0.12%+0.05%+0.1%+0.005%+0.01%

CENTAUR PHARMACEUTICALS PRIVATE LIMITED-PLOT NO.3,TIVIM INDUSTRIAL ESTATE KARASWADA MUPUSA-GOA 403 526 INDIA

CENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEAR

CENTAUR PHARMACEUTICALS PVT L.T.D.-CENTAUR HOUSE NEAR

CENTAUR PHARMACEUTICALS PVT LTD --PLANT II PLOT 39-41 TIVIM INDUSTRIAL ESTATE KARASWADA MAPUSA GOA 403 526

PARACETAMOL/PHENYLEPHERINE HYDROCHLORIDE/CHLORPHENIRAMINE MALEATE/CAFFEINE

500MG+5MG+2MG+30MG

CENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

Page 451: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1MG/ML+3MG/ML INDIA

OXYMETAZOLINE 0.05%W/V INDIA

INDIA

PIPERAZINE CITRATE 750ML/5ML INDIA

2MG+10MG+1.5MG INDIA

AMLODIPINE 5MG INDIA

MULTI INGREDIENT N/A INDIA

CHLORAMPHENICOL 1%W/W INDIA

CLOTRIMAZOLE 1%W/W INDIA

DROTAVERINE HYDROCHLORIDE 40MG HUNGARY

DROTAVERINE HCL 80MG HUNGARY

DROTAVERINE HYDROCHLORIDE 40MG/2ML HUNGARY

SILDENAFIL CITRATE 100 MG INDIA

SILDENAFIL CITRATE 50MG INDIA

INDIA

ARTEMETHER + LUMEFANTRINE 80MG + 480MG INDIA

PRAZIQUANTEL 600MG INDIA

MISOPROSTOL 200MCG INDIA

DICLOFENAC SODIUM+GENTAMICIN SULPHATE

CENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CENTAUR PHARMACEUTICALS PVT LTD --PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE+SIMETHICONE

40MG+200MG+250MG/5ML

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CHLORPHENIRAMINE+DEXTROMETHORPHAN+METHANOL

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CENTAUR PHARMACEUTICALS PVT LTD-PLOT NO.3 TIVIN INDUSTRIAL ESTATE KARASWADA 403526 INDIA

CHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.

CHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.

CHINOIN PHARMACEITCAULS AND CHEMICAL WORKS CO. LTD-H10-45 BUDAPEST TOU HUNGARY.

CIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802CIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802

LANSOPRAZOLE+TINIDAZOLE+CLARITHROMYCIN

30MG+500MG+250 MG

CIPLA LIMITED PUNE-MIDC, KURKUMBH DISTRICT PUNE 413802

CIPLA LIMITED--UNIT 1,VILLAGE UPPER MALPUR, P.O. BHUD, TEHSIL NALAGARH, DISTRICT SOLAN, HIMACHAL PRADESH 173205, INDIA

CIPLA LTD .-352 KUNDAIM INDL. ESTATE KUNDAIM GOA 403 115CIPLA LTD .-CIPLA GOA UNIT 8 L-147 TO L-147/1 L-147-3 TO L-138 VERNA INDUSTRIAL ESTATE VERNA GOA

Page 452: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SALBUTAMOL 100MCG/DOSE INDIA

PARACETAMOL 500MG INDIA

LAMIVUDINE 50MG/5ML INDIA

INDIA

PREDNISOLONE 5MG INDIA

TENOFOVIR DISOPROXIL FUMARATE 300MG INDIA

300/200/600MG INDIA

CYCLOSERINE 250MG CIPLA LTD -CIPLA LTD VERNA IND BT GOA 403722 INDIA

METFORMIN HCL 1000MG INDIA

ARTEMETHER + LUMEFANTRINE 20MG + 120 MG INDIA

MOMETASONE FUROATE 50MCG /SPRAY INDIA

ARTEMETHER+LUMEFANTRINE 20MG+120MG INDIA

CLOTRIMAZOLE 1%W/W INDIA

CIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH

CIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH

CIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE

150MG + 300MG + 200MG

CIPLA LTD .-PLOT NO. 9, 10 AND 15, INDORE SPECIAL ECONOMIC ZONE, PHASE –II, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH,CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA

CIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA

TENOFOVIR/ EMTRICITABINE/ EFAVIRENZ

CIPLA LTD .-PLOT NO. S-103 TO S-105, S-107 TO S-112, L-147 TO L-1147-1, VERNA ELECTRONIC CITY GOA

CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TALCIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775

CIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775CIPLA LTD INDORE-PLOT 9 & 10 INDORE SEZ PITHAMPUR M.P 454 775

CIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722

Page 453: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MONTELUKAST SODIUM 5MG INDIA

LOPINAVIR + RITONAVIR 200MG + 50MG INDIA

INDIA

MOXIFLOXACIN 400MG INDIA

HYOSCINE BUTYL BROMIDE 10MG INDIA

300MG+300MG INDIA

ATORVASTATIN CALCIUM 20MG INDIA

NEVIRAPINE 50MG/5ML INDIA

OMEPRAZOLE 20 MG INDIA

FLUOXETINE 20MG INDIA

FLUCONAZOLE 200MG INDIA

UGANDA

ARTESUNATE+AMODIAQUINE 100MG+270MG INDIA

ARTESUNATE+AMODIAQUINE 50MG+135MG INDIA

PRAZIQUANTEL 600MG INDIA

ARTESUNATE+AMODIAQUINE 25MG+67.5MG INDIA

LAMIVUDINE + ZIDOVUDINE 30MG + 60MG INDIA

LAMIVUDINE,+ ZIDOVUDINE 150MG+300MG INDIA

CIPLA LTD ----L139 TO L-146 VERNA INDUSTRIAL ESTATE VERNA SALCETTE GOA 403 722

CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845

EFAVIRENZ + LAMIVUDINE + TENOFOVIR

600MG +300MG + 300MG

CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845

CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845

CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845

LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE

CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845

CIPLA LTD -MIDC PATALGANGA MS 410 220 INDIA MFG LIC: 845

CIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA

CIPLA LTD --PLOT NO 9, 10 & 15, PHARMA ZONE, PHASE II,SECTOR III, INDORE SPECIAL ECONOMIC ZONE, PITHAMPUR, DIST: DHAR, MADHYA PRADESH – 454 775, INDIA

CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIACIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA

ZIDOVUDINE + LAMUVIDINE + NEVIRAPINE

300MG/150MG/ 200MG

CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA

CIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATECIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATECIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATECIPLA LTD UNIT II-A-42 MIDC PATALGANGA DISTRICT RAIGAD MAHARASHTRA STATECIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

Page 454: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LEVOSALBUTAMOL 50MCG INDIA

100MG INDIA

LAMIVUDINE 10MG/ML INDIA

BECLOMETHASONE DIPROPIONATE 50MCG/ACTUATION INDIA

BECLOMETHASONE DIPROPIONATE 50MCG INDIA

INDIA

INDIA

300MG+200MG INDIA

LEVOFLOXACIN 250MG INDIA

EFAVIRENZ 600MG INDIA

LEVONORGESTREL 0.75MG INDIA

SECNIDAZOLE 1000MG INDIA

LEVOFLOXACIN 500MG INDIA

BECLOMETASONE 200MCG/DOSE INDIA

25MCG + 250MCG INDIA

LEVONORGESTREL 1.5MG INDIA

LAMIVUDINE 150MG INDIA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

HYDROCORTISONE SODIUM SUCCINATE

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

150MG + 300MG + 200MG

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

IPRATROPIUM BROMIDE & SALBUTAMOL

500MG + 2.5 MG /2.5ML

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

TENOFOVIR DISOPROXIL FUMARATE + EMTRICITABINE

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

SALMETEROL+ FLUTICASONE PROPIONATE

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

Page 455: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

ENOXAPARIN SODIUM 40MG/0.4ML INDIA

AZITHROMYCIN 500MG INDIA

TENOFOVIR DISOPROXIL FUMARATE 300 MG INDIA

ABACAVIR SULFATE + LAMIVUDINE 600 MG + 300 MG INDIA

ABACAVIR SULFATE + LAMIVUDINE 60MG + 30MG INDIA

AMLODIPINE BESYLATE 5MG INDIA

TADALAFIL 20MG INDIA

25MCG + 125MCG INDIA

AMPHOTERICIN B 50MG INDIA

AMIKACIN 500MG/2ML INDIA

NIFEDIPINE 20MG INDIA

ABACAVIR SULPHATE 300MG INDIA

METFORMIN HYDROCHLORIDE 500MG INDIA

ABACAVIR SULPHATE 60MG INDIA

NEVIRAPINE 200MG INDIA

MICONAZOLE NITRATE 2%W/W INDIA

NEVIRAPINE 200MG INDIA

CLOPIDOGREL BISULPHATE 75MG INDIA

CETIRIZINE HYDROCHLORIDE 5MG/5ML INDIA

60MG + 30MG INDIA

ETHIONAMIDE 250MG INDIA

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

30MG +50MG + 60MG

CIPLA LTD.- -PLOT NO L/139 TO L/146, VERNA INDUSTRIAL ESTATE, VERNA, SOUTH GOA DISTRICT, 403722 GOA

CIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIACIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIACIPLA LTD.-VERNA IND. ESTATE GOA 403 722 INDIACIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220CIPLA LTD-A-33 & A-37/2/2 MIDC PATALGANGA 410220CIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIACIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA

SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE

CIPLA LTD-CIPLA LTD PLOT NO L-139,VERNA IND ESTATE, VERNA GOA INDIA

CIPLA LTD-M-61, M-62 & M-63, VERNA INDUSTRIAL ESTATE VERNA GOA,INDIACIPLA LTD-M-61, M-62 &M-63 UNIT IX VERNA INDUSTRIAL ESTATE, VERNA, SALCETTE GOA 403 722

CIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADCIPLA LTD-MIDC PATALGANGA 410 220 DIST. RAIGADCIPLA LTD-PATALGANGA UNIT II PLOT MO A-33 A42 MIDC RAIGADCIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIACIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIACIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIACIPLA LTD--PLOT NO L-139,VERNA IND ESTATE, VERNA GOA-403 INDIACIPLA LTD---PLOT NO. 9 & 10 PHARMA ZONE, PHASE –II, INDORE SEZ, PITHAMPUR, DISTRICT DHAR, PIN CODE: 454775, MADHYA PRADESH

ABACAVIR SULPHATE + LAMIVUDINE

CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA

CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA

Page 456: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ALBENDAZOLE 400MG INDIA

ABACAVIR 300MG INDIA

NORETHISTERONE ACETATE 5MG INDIA

CLOMIPHENE 50MG INDIA

ALBENDAZOLE 20MG/5ML CIPLA LTD-VERNA INDUSTRIAL ESTATE, GOA INDIA

ACICLOVIR 5%W/W CIPLA LTD-VERNA INDUSTRIAL ESTATE, GOA INDIA

LAMIVUDINE/ZIDOVUDINE 150MG/300MG UGANDA

NEVIRAPINE 200MG UGANDA

ZIDOVUDINE+ LAMIVUDINE 300MG + 150MG UGANDA

INDIA

300MG+300MG INDIA

EFAVIRENZ 600MG INDIA

EFAVIRENZ 600MG UGANDA

300MG UGANDA

ENTECAVIR 0.5MG UGANDA

ENTECAVIR MONOHYDRATE 1.0MG UGANDA

300MG+300MG UGANDA

CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220 DIST-RAIGAD, MAHARASHTRA INDIA

CIPLA LTD-UNIT I & II A-32 & A-42 MIDC PATALGANGA 410220, DIST- RAIGAD, MAHARASHTRA, INDIA

CIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDACIPLA LTD-VERNA INDIA ESTATES 403722 GOA INDA

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA

EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE

600MG+300MG+300MG

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA L.T.D -MIDC PATALGANGA MAHARASHTRA 410 220

LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA LTD ----D-7 MIDC INDUSTRIAL AREA, KURKUMBH, TAL

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED - -PLOT 1-7 1ST RING ROAD, LUZIRA, KAMPALA,CIPLA LTD -PLOT NO. L-139, VERNA, GOA 403 722 INDIA

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA

TENOFOVIR DISOPROXIL FUMARATE CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA

CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED-PLOT 1-7, LUZIRA

LAMIVUDINE+TENOFOVIR DISOPROXIL FUMARATE

CIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDA

Page 457: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

UGANDA

NYSTATIN 100000 UNITS/5ML INDIA

DICLOFENAC 25MG/ML INDIA

DIAZEPAM 5MG/ML INDIA

BETAMETHASONE+NEOMYCIN INDIA

LIDOCAINE HYDROCHLORIDE 20MG/ML INDIA

METOCLOPRAMIDE 5MG/ML INDIA

INDIA

DICLOFENAC DIETHYLAMINE BP 1%W/W INDIA

CETIRIZINE HYDROCHLORIDE 5MG/5ML INDIA

HYDROCORTISONE 100MG INDIA

PHYTOMENADIONE 10MG/ML INDIA

CHLORPROMAZINE 25MG/ML INDIA

ADRENALINE 1MG/ML INDIA

10MG + 40MG/ 5ML INDIA

10MG + 40MG/ 5ML INDIA

EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE

600 MG + 300 MG + 300 MG

CIPLA QUALITY CHEMICALS INDUSTRIES LIMITED--PLOT 1-7 1ST RING ROAD, LUZIRA INDUSTRIAL PARK P O BOX 34871, KAMPALA, UGANDA

CIRON DRUGS & PHARMACEUTICAL PVT LTD -N-118, N-119, N-113, MIDC TARAPUR, BOISAR DIST: THANE-401 506 MAHARASHTRA, INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.

CIRON DRUGS & PHARMACEUTICALS PVT LTD .-N-118,M.I.D.C, TARAPUR,BOISAR, DIST.THANE-401506, MAHARASHTRA,INDIA.

0.1%W/W+0.5%W/W

CIRON DRUGS & PHARMACEUTICALS PVT LTD.-N-118 MIDC TARAPUR BOISAR DIST THANE 401 506 MAHARASTHTRA

CIRON DRUGS & PHARMACEUTICALS PVT LTD.-N-118 MIDC TARAPUR BOISAR DIST THANE 401 506 MAHARASTHTRA

CIRON DRUGS & PHARMACEUTICALS PVT LTD.-N-118 MIDC TARAPUR BOISAR DIST THANE 401 506 MAHARASTHTRA

PARACETAMOL + PHENYLEPHRINE HYDRCHLORIDE + CHLORPHENIRAMINE MALEATE

125MG + 2.5MG + 2.5MG/ 5ML

CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506

CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506

CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506

CIRON DRUGS & PHARMACEUTICALS PVT LTD--N-118, 119 MIDC TARAPUR BOISAR DIST THANE 4011 506

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

DICYCLOMINE HYDROCHLORIDE + SIMETICONE

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

DICYCLOMINE HYDROCHLORIDE + SIMETICONE

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

Page 458: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML INDIA

CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML INDIA

PROMETHAZINE HYDROCHLORIDE 25MG/ML INDIA

THIOPENTAL SODIUM 1GM / VIAL INDIA

ERGOMETRINE MALEATE 0.5MG/ML INDIA

QUININE DIHYDROCHLORIDE 300MG/ML INDIA

CHLORAMPHENICOL 5%W/V INDIA

ATROPINE 1MG/ML INDIA

FUROSEMIDE 10MG/ML INDIA

GENTAMYCIN 0.3%W/V INDIA

CHLORAMPHENICOL 0.5%W/V INDIA

1G INDIA

ARTEMETHER 80MG/ML INDIA

KETAMINE 50MG/ML INDIA

FLUCONAZOLE 2MG/ML INDIA

PARACETAMOL 10MG/ML INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

CIRON DRUGS & PHARMACEUTICALS PVT LTD-N-118, N-119 MIDC TARAPUR BOISAR DIST THANE 401506 MAHARASHTRA INDIA

CIRON DRUGS AND PHARMACEUTICALS PRIVATE LTD-N-118 MIDC TARAPUM BOISAR DIST THANE 401506 MAHARASHTRA, INDIA

CIRON DRUGS AND PHARMACEUTICALS PVT LIMITED-N-118, N119, N113, MIDC TARAPUR BOISAR DIST THANE 401506, INIDA

CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA

CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA

CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA

CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA

CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA

CHLORAMPHENICOL SODIUM SUCCINATE

CIRON DRUGS AND PHARMACEUTICALS PVT LTD-N-118 M.I.D.C, TAAPUR,BOISAR,DIST.THANE MAHARASHTRA INDIA

CIRON DRUGS AND PHARMACEUTICALS PVT. LTD-N-118, N119, N113, MIDC, TARAPUR, BOISAR, DIST. THANE 401506, INDIA

CLARIS INJECTABLE LIMITED--CHACHARWADI VASANA AHMEDABAD GUJARATCLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT

CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT

Page 459: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BUPIVACAINE 0.5% W/V INDIA

0.5%W/V INDIA

PROPOFOL 10MG/ML INDIA

PROPOFOL 1%W/V INDIA

FLUMAZENIL 0.1MG/ML INDIA

INDIA

OFLOXACIN 2 MG/ML INDIA

HYDROXYETHYLSTARCH 6%W/V CLARIS OTSUKA PRIVATE LIMITED-N3 INDIA

PROPOFOL 20MG/ML ITALY

PROPOFOL 1%W/V ITALY

PANTOPRAZOLE 40MG INDIA

INDIA

ONDANSETRON 4MG INDIA

CODEINE PHOSPHATE 30MG KENYA

PARACETAMOL 500MG KENYA

AMINOSIDINE 125MG/5ML KENYA

CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT

BUPIVACAINE HYDROCHLORIDE IN DEXTROSE

CLARIS INJECTABLES LIMITED---CHACHARWADI VASANA 382 213 AHMEDABAD GUJARAT

CLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIA

CLARIS LIFE SCIENCES LIMITED-CHACHOSWADIII VASNA.AHMEDABAD-382213,INDIA

CLARIS LIFE SCIENCES LTD-CHACHARWADI-VASANA,SANAND, AHMEDABAD GUJARAT-382213 INDIA

SODIUM ACETATE + DIBASIC POTASSIUM PHOSPHATE + MAGNESSIUM CHLORIDE + DEXTROSE MONONOHYDRATE + POTASSIUM CHLORIDE

(0.32G + 0.026G + 0.031G + 5.50G + 0.13G)/100ML

CLARIS OTSUKA LIMITED .-VILLAGE VASANA CHACHARWADI TAL:SANAD DIST -AHMEDABAD 382 213

CLARIS OTSUKA LIMITED-VILLAGE – VASANA – CHACHARWADIP,TAL: SANAND, AHMADABAD

CORDEN PHARMA SPA-VIALE DELL INDUSTRIA 3 REPAR TO VIA GAB'LEI 1720040CORDEN PHARMA SPA-VIALE DELL INDUSTRIA 3 REPAR TO VIA GAB'LEI 1720040CORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA

DICLOFENAC POTASSIUM+PARACETAMOL+CHLORZOXAZONE

50MG+325MG+250MG

CORONA REMEDIES PVT LIMITED-VILLAGE JATOLI, POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. SOLAN HIMACHAL PRADESH – 173223. INDIA

CORONA REMEDIES PVT LTD--VILLAGE JATOLI,POST OFFICE - OACHGHAT, TEHSIL SOLAN, DIST. OLAN HIMACHAL PRADESH

COSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA

COSMOS LIMITED -RANGWA ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA

COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA

Page 460: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FERROUS FUMERATE 300MG KENYA

KENYA

KENYA

ZINC SULPHATE 20MG KENYA

METHYLDOPA 250MG KENYA

CO-TRIMOXAZOLE 480MG KENYA

LORATADINE 5MG/5ML KENYA

NYSTATIN 100,000 I.U/ML KENYA

PRAZIQUANTEL 600MG KENYA

SALBUTAMOL 2MG/5ML KENYA

PARACETAMOL/CAFFEINE 500MG+65MG KENYA

NITROFURANTOIN 100MG INDIA

NYSTATIN 100,000 I.U KENYA

NYSTATIN 100.000 I.U KENYA

ORAL REHYDRATION SALT N/A KENYA

SALBUTAMOL 4MG KENYA

COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA

TABLET-ZINC, SACHET-NACL + KCL + TRISODIUM CITRATE + ANHYDROUS GLUCOSE

TABLET-54.89MG , SACHET 1.3G + 0.75G + 1.45G + 6.75G

COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA

THIAMINE + PYRIDOXINE + CYANOCOBALAMIN

200MG + 50MG +1000MCG

COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA

COSMOS LIMITED, KENYA-RANGWE ROAD, OFF LUNGA ROAD, INDUSTRIAL AREA NAIROBI - KENYA

COSMOS LIMITED..-RANGWE ROAD, OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

Page 461: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FUROSEMIDE 40MG KENYA

CO-TRIMOXAZOLE 960MG KENYA

METFORMIN 500MG KENYA

HYDRALAZINE HYDROCHLORIDE 25MG KENYA

PROPRANOLOL HYDROCHLORIDE 40MG KENYA

PYRAZINAMIDE 500MG KENYA

DIAZEPAM 5MG KENYA

PHENOBARBITONE 30MG KENYA

TRIHEXYPHENIDYL HYDROCHLORIDE 5MG KENYA

ALBENDAZOLE 400MG KENYA

ISONIAZID 100MG KENYA

ACETYL SALICYLIC ACID 75MG KENYA

PARACETAMOL 120MG/5ML KENYA

CHLORPROMAZINE 25MG KENYA

100MG KENYA

AMITRIPTYLINE 25MG KENYA

MAGNESIUM TRISILICATE 370MG KENYA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED--RANGWA ROAD, OFF LUNGA LUNGA ROAD,P.O BOX 414 33, NAIORBI INDUSTRIAL AREA

COSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBICOSMOS LIMITED-RANGWE ROAD, OFF LUNGA ROAD - INDUSTRIAL AREA NAROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

CHLORPROMAZINE HYDROCHLORIDE

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

Page 462: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

KENYA

ATENOLOL 100MG KENYA

ETHAMBUTOL 400MG KENYA

AZITHROMYCIN 500MG KENYA

AZITHROMYCIN 200MG/5ML KENYA

N/A KENYA

LORATADINE 10MG KENYA

CHLORHEXIDINE GLUCONATE 20%W/V KENYA

BENZHEXOL HCL 2MG KENYA

ATENOLOL 50MG KENYA

BENDROFLUMETHIAZIDE 5MG KENYA

AZITHROMYCIN 250MG KENYA

PROMETHAZINE HYDROCHLORIDE 25MG KENYA

CIPROFLOXACIN 500MG KENYA

MULTI-INGREDIENT MULTI-INGREDIENT KENYA

MULTI-INGREDIENT MULTI-INGREDIENT KENYA

MULTIINGREDIENT NA KENYA

GRISEOFULVIN 500MG KENYA

METRONIDAZOLE 200MG KENYA

AMPICILLIN SODIUM 500MG CHINA

BENZATHINE PENICILLIN 2.400.000 IU CHINA

SALBUTAMOL SULPHATE+BROMOHEXINE HYDROCHLORIDE+GUAIFENESIN+MENTHOL

1MG+2MG+50MG+0.5MG

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

ATTAPULGITE/ ALUMINIUM HYDROXIDE

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

COSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBICOSMOS LTD.-RANGWE ROAD; OFF LUNGA LUNGA ROAD. P.O BOX 414 33, NAIROBI

CSPC ZHONGNUO (SHIJIAZHUANG) PHARMACEUTICAL CO LTD-NO. 47 FENGSHOU ROAD SHIJIAZHUANG,CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

Page 463: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BENZYLPENICILLIN SODIUM 1000000 I.U CHINA

AMPICILLIN SODIUM 500MG CHINA

BENZATHINE PENICILLIN 2.4 M.U CHINA

FORTIFIED PROCAINE PENICILLIN 4 MEGA UNITS CHINA

BENZATHINE PENICILLIN 2400000 I.U CHINA

BENZYLPENICILLIN SODIUM 1,000,000I.U CHINA

FORTIFIED PROCAINE PENICILLIN 4000000 IU CHINA

BENZYLPENICILLIN 1 MU CHINA

CLOXACILLIN SODIUM 500MG CHINA

CLOXACILLIN SODIUM 500MG CHINA

CEFTRIAXONE SODIUM 1G CHINA

STREPTOMYCIN SULPHATE 1GM CHINA

FERROUS SULPHATE 200MG INDIA

DEXAMETHASONE 0.5MG INDIA

PROMETHAZINE HYDROCHLORIDE 25MG INDIA

LEVAMISOLE HYDROCHLORIDE 40MG INDIA

ACTIVATED CHARCOAL 250MG INDIA

PHENOBARBITONE 30MG INDIA

CODEINE PHOSPHATE 30 MG INDIA

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO, LTD.-NO.47 FENGSHOU ROAD, SHIJIAZHUANG CITY, CHINA.

CSPC ZHONGNUO PHARMACEUTICALS LTD-NO. 88, YANGZI ROAD, SHIJIAZHUANG CITY CHINA

CSPC ZHONGUO (SHIJIAZHUANG) PHARMACEUTICAL CO.LTD-NO. 188 GONGNONG

CYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORECYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORECYANO PHARMA(P)-115-C IND ESTATE POLO GROUND INDORE

CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015

CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015CYANO PHARMA(P)-115-C IND ESTATE POLOGROUND, INDORE 452015

Page 464: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LEVOFLOXACIN 500MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

ROSUVASTATIN CALCIUM 40MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

PREGABALIN 75MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

METFORMIN 850MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

150MG+12.5MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

300MG/12.5MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

ATORVASTATIN 10MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

CEPHALEXIN 250MG/5ML DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

CEPHALEXIN MONOHYDRATE 125MG/5ML DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

IRBESATAN 150MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN

IRBESARTAN 300MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

RISPERIDONE 1MG/ML DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

ROSUVASTATIN CALCIUM 10MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

ROSUVASTATIN CALCIUM 20MG DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN JORDAN

PREGABALIN 150MG JORDAN

LEVOFLOXACIN 500MG JORDAN

IRBESARTAN+HYDROCHLOROTHIAZIDE

IRBESARTAN/HYDROCHLOROTHIAZIDE

NETHERLANDS

DAR AL DAWA DEVELOPMENT & INVESTMENT COMPANY LTD-P.O.BOX 16633-00620,NAIROBI, KENYA.

DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. LTD, -NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET, AMMAN, JORDAN

Page 465: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GABAPENTIN 300MG JORDAN

RISPERIDONE 2MG JORDAN

LORATIDINE 5MG/5ML JORDAN

DICLOFENAC SODIUM. 100MG JORDAN

DICLOFENAC SODIUM 100MG JORDAN

DICLOFENAC SODIUM 12.5MG JORDAN

DICLOFENAC 50MG JORDAN

CIPROFLOXACIN 500MG JORDAN

CEFUROXIME 500MG JORDAN

CLOMIPHENE 50MG JORDAN

METFORMIN HYDROCHLORIDE 1000MG JORDAN

METFORMIN 500MG JORDAN

AMOXYCILLIN TRIHYDRATE 125MG/5ML DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

DAR AL DAWA-DAR AL DAWA DEVELOPMENT AND INVESTMENT CO LTD. NA’UR PRINCE HASHEM BIN AL-HUSSEIN STREET. AMMAN, JORDAN

Page 466: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN/CLAVULANIC ACID 875MG/125MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

CLOPIDOGREL BISULFATE 30MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

AMOXICILLIN + CLAVULANIC DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

IBUPROFEN/PSEUDOEPHEDRINE 200MG/30MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

AMLODIPINE BESILATE 5MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

AMLODIPINE BESILATE 10MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

AMOXICILLIN TRIHYDRATE 250MG/5ML DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

AMOXICILLIN/CLAVULANIC ACID 500MG/125MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

AMOXICILLIN/CLAVULANIC ACID 400MG/57MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

ATORVASTATIN 20MG DAR AL DAWA-NA'UR PLANT AMMAN JORDAN

OMEPRAZOLE 20MG JORDAN

DAWA LIMITED -BABA DOGO RWARAKA KENYA

DAWA LIMITED -BABA DOGO RWARAKA KENYA

SALBUTAMOL SULPHATE 2MG/5ML DAWA LIMITED -BABA DOGO RWARAKA KENYA

MEBENDAZOLE 100MG/5ML DAWA LIMITED -BABA DOGO RWARAKA KENYA

HYDROCORTISONE 1%W/W KENYA

AMPICILLIN TRIHYDRATE 125MG/5ML KENYA

BENZOIC ACID + SALICYLIC ACID KENYA

200MG + 28MG /5ML

DAR AL DAWA-NA'UR PLANT AMMAN,DAR AI DAWA-NA UR PLANT,AMMAN,JORDAN

CAFFEINE ANHYDROUS+CHLORPHENIRAMINE MALEATE+PARACETAMOL+PSUDOEPHEDRINE

30MG+4MG+400MG+30MG

SILVER SULPHADIAZINE AND CHLORHEXIDINE GLUCONATE

1%W/W / 10.0%W/W

DAWA LTD -BABA DOGO ROAD, RUARAKA P.O.BOX 16633-00620, NAIROBI KENYADAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

6.0%W/W +3.0%W/W

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

Page 467: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFALEXIN 250MG KENYA

DIAZEPAM 5MG KENYA

KENYA

KENYA

KENYA

PARACETAMOL/CAFFEINE 500MG/60MG KENYA

SALBUTAMOL 4MG KENYA

KENYA

SULPHUR 10%W/W KENYA

ASCORBIC ACID 100 MG INDIA

MULTI-INGREDIENT MULTI-INGREDIENT KENYA

KENYA

PROMETHAZINE HCL 5MG/5ML KENYA

SECNIDAZOLE 1G KENYA

NYSTATIN 100000IU/ML KENYA

PREDNISOLONE 5MG KENYA

KENYA

KENYA

ACECLOFENAC + PARACETAMOL 100 MG + 500 MG DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

CHLORPHENIRAMINE MALEATE 4MG DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

PHENOBARBITAL 30MG DAWA LTD-BABA DOGO ROAD RUARAKA INDIA

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

DIPHENHYDRAMINE + DEXTROMETHORPHAN + MENTHOL

12.5MG + 6.5MG + 1.10MG

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE + SODIUM CITRATE + MENTHOL

14.0MG + 135.0MG + 57.0MG + 1.10MG

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

DIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + MENTHOL

75MG + 28.5MG + 0.55MG

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

SALBUTAMOL + BROMOHEXINE + GUAIPHENESIN + MENTHOL

2.OMG + 4.0MG +100MG + 1.0MG

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

MICONAZOLE NITRATE + CLOBETASOL PROPRIONATE + GENTAMICN

2%W/W+0.5%W/W+0.1W/W

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBIDAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

PARACETAMOL+ACETYLSALICYLIC ACID+CAFFEINE

200MG+300MG+30MG

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

PARACETAMOL +ACECLOFENAC+CHLORZOXAZONE

500 MG+100 MG +375 MG

DAWA LTD -PLOT NO.7879/8 BABA ROAD RUARAKA NAIROBI

Page 468: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PROMETHAZINE HCL 25MG DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

PARACETAMOL 120MG/5ML DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

CEFALEXIN MONOHYDRATE 125MG/5ML DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

MICONAZOLE NITRATE 2%W/W DAWA LTD-BABA DOGO ROAD RUARAKA KENYA

AMOXYCILLIN TRIHYDRATE 250MG KENYA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG KENYA

AMPICILLIN + CLOXACILLIN 125 MG + 125 MG KENYA

CHLORPHENIRAMINE MALEATE 2MG/5ML KENYA

KENYA

250MG + 250MG KENYA

AMOXYCILLIN TRIHYDRATE 125MG/5ML KENYA

ALBENDAZOLE 200MG/5ML KENYA

KENYA

DICLOFENAC SODIUM 12.5MG FRANCE

DICLOFENAC SODIUM 25MG FRANCE

DICLOFENAC SODIUM 50MG FRANCE

CARBAMAZEPINE 20MG/ML FRANCE

PARACETAMOL + PSEUDOEPHEDRINE HCL + CHLORPHENIRAMINE MALEATE

120MG/5ML+10MG/5ML+2MG/5ML

ACECLOFENAC + SERRATIOPEPTIDASE + PARACETAMOL

100MG + 15MG + 500MG

DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA

DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKADAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA

DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA

DICLOFENAC DIETHYLAMINE + METHYL SALICYLATE + LINSEED OIL + MENTHOL CRYSTALS

1.16%W/W + 10%W/W + 3%W/W + 5%W/W

DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA

FLUCLOXACILLIN SODIUM + AMOXICILLIN TRIHYDRATE

DAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKADAWA PHARMACEUTICALS LIMITED-PLOT 7879, BABA DOGO ROAD RUARAKA

DAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYA

MAGNESIUM TRISILICATE + ALUMINIUM HYDROXIDE

250MG/5ML + 120MG/5ML

DAWA-PLOT 7879, BABA DOGO ROAD RUARAKA, NAIROBI, KENYADELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE

DELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE

DELPHARM HUNINGUE S.A.S--SITE INDUSTRIAL HUNINGUE26, RUE DE LA CHAPELLE, F-68330, HUNINGUE

DELPHARMA HUNINGUE S.A.S-26, RUE DE LA CHAPELLE, 68330 HUNINGUE, FRANCE

Page 469: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DESLORATIDINE 5MG GERMANY

VALSARTAN 160MG GERMANY

VALSARTAN 320MG GERMANY

VALSARTAN 80MG GERMANY

THIAMINE HCL + PYRIDOXINE HCL 100MG + 200MG GERMANY

SIMVASTATIN 40MG GERMANY

NIFEDIPINE 20MG GERMANY

RANITIDINE 150MG GERMANY

DICLOFENAC SODIUM 25MG/ML GERMANY

TORASEMIDE 10MG GERMANY

TORASEMIDE 5MG GERMANY

DICLOFENAC SODIUM 50MG GERMANY

50MG + 12.5MG GERMANY

LOSARTAN 100MG GERMANY

METFORMIN 500MG GERMANY

METFORMIN 1000MG GERMANY

DENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYDENK PHARMA GMBH & CO.KG -GOLLSTR 1,84529 TITTMONING GERMANYDENK PHARMA GMBH & CO.-PRINZREGENTENSTR. 79, 81675 MÜNCHEN, GÖLLSTR. 1, 84529 TITTMONING, GERMANY

DENK PHARMA GMBH & CO-G0 11 STR.1 84529 T,HMONING GERMANYDENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529

DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

LOSARTAN + HYDROCHLOROTHIAZIDE

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

Page 470: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DICLOFENAC SODIUM 100MG GERMANY

IBUPROFEN 400MG GERMANY

METFORMIN HYDROCHLORIDE 850MG GERMANY

ENALAPRIL MALEATE 10MG GERMANY

100MG + 12.5MG GERMANY

LOSARTAN 50MG GERMANY

10MG GERMANY

5MG GERMANY

ACYCLOVIR 200MG GERMANY

CLOTRIMAZOLE 100MG GERMANY

TRIAMCINOLONE ACETONIDE 40 MG/ML GERMANY

CAPTOPRIL 25MG GERMANY

AZITHROMYCIN DIHYRATE 500MG TURKEY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE

DENK PHARMA GMBH &CO.KG--PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

AMLODIPINE MESILATE MONOHYDRATE

DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

AMLODIPINE MESILATE MONOHYDRATE

DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY

DENK PHARMA GMBH &CO.KG-PRINZREGENTESTR.79.81675 MUENCHEN, GERMANY, GOLLSTR, 1-D-845529 TITTMONING GERMANY,ARTESAN PHARMA GMBH & CO. KG -WENDLANDSTRABE 1,29439 LUCHOW,GERMANY

DENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY

DENK PHARMA, GOLLSTR.,-1-D-845 529 TITTMONING GERMANY

DEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAAĞAÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDAĞ/ TURKEY

Page 471: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SILDENAFIL CITRATE 50MG TURKEY

SALBUTAMOL SULPHATE 120.5MCG/SPRAY TURKEY

AZITHROMYCIN 500MG TURKEY

CEFTRIAXONE SODIUM 1G TURKEY

AMLODIPINE BESILATE 10MG TURKEY

AMLODIPINE BESILATE 5MG TURKEY

CO-TRIMOXAZOLE 480MG/5ML DRAXIS PHARMA INC.- QUEBEC, CANADA CANADA

AMLODIPINE BESILATE 5 MG TURKEY

CIPROFLOXACIN HYDROCHLORIDE 500MG TURKEY

AMLODIPINE BESILATE 10MG TURKEY

EGYPT

EGYPT

MEBEVERINE 135MG EGYPT

TOBRAMYCIN 3MG/G EGYPT

GENTAMICIN SULFATE 0.3%W/W EGYPT

NEOSTIGMINE METHYLSULPHATE 0.05%W/V EGYPT

DEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAAĞAÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDAĞ/ TURKEY

DEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAAĞAÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDAĞ/ TURKEY

DEVA HOLDING A. S.-ÇERKEZKÖY ORGANIZE SANAYI BOLGESI. KARAAĞAÇ MAH. ATATÜRK CAD. NO: 32 KAPAKLI- TEKIRDAĞ/ TURKEY

DEVA LIAC SAN. VE TIC. A.S. -ORGANISE SANAYI BOLGESI ATATURK MAH. ATATURK CAD. NO: 32 KARAAGAC CERKEZKOY

DEVA-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLI

DEVA-CERKEZKOY ORGANIZE SANAYI BOLGESI KARAAGAC MAH ATATURK CAD.,NO.: 32 KAPAKLI

DROGSAN İLAÇLARI SAN. VE TIC. A.Ş.-06760 ÇUBUK –ANKARA / TURKEYDROGSAN İLAÇLARI SAN. VE TIC. A.Ş.-ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEY

DROGSAN İLAÇLARI SAN. VE TIC. A.Ş.-ESENBOGA MERKEZ MAH CUBUK CAD NO.31 CUBUK ANKARA -TURKEY

DRIED ALUMINIUM HYDROXIDE + MAGNESSIUM HYDROXIDE + OXETHAZAINE

8G/100ML + 2G/100ML + 0.2 G/100ML

EGYPIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO EIPICO-10TH OF RAMADAN CITY-FIRST INDUSTRIAL AREA -EGYPT

GUAIPHENESIN+EPHEDRINE HYDROCHLORIDE+DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN

50MG+7.5MG+5MG+4.58MG

EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. EIPICO-10TH STREET RAMADAN CITY, FIST INDUSTRIES ARE

EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)-EGYPTIAN INT.PHARMACEUTICAL INDUSTRIES CO (E.I.P.C.O)

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA BEGYPT

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA BEGYPT

EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO. A.R.E-10TH OF RAMADAN CITY INDUSTRIAL AREA B1,EGYPT

Page 472: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

HUMAN INSULIN 100IU FRANCE

HUMAN INSULIN ISOPHANE 100IU EGYPT

HUMAN INSULIN 70/30 I.U

CLOBETASOL 0.05%W/W ITALY

CLOBETASOL PROPIONATE 0.05%W/W ITALY

CLOBETASOL PROPIONATE 0.05G/100G ITALY

AZITHROMYCIN DIHYDRATE 500 MG BANGLADESH

150MG +500MCG BANGLADESH

DIACEREIN 50MG EGYPT

FUSIDIC ACID 2%W/W EGYPT

GABAPENTIN 100MG EGYPT

GABAPENTIN 300MG EGYPT

EGYPT

LEFLUNOMIDE 20MG INDIA

LORNOXICAM 8MG EGYPT

MOXIFLOXACIN 400MG INDIA

THIOTIC ACID 600MG EGYPT

ELI LILLY & COMPANY-LILLY TECHNOLOGY CENTER, 1555 S HARDING, INDIANAPOLIS, INDIANA, 46221,LILLY FRANCE SA-FRANCE

ELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USAELI LILLY AND COMPANY LILLY TECHNOLOGY CENTRE INDIANAPOLIS,-INDIANA 46285 USA

UNITED STATES

ESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY

ESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY

ESAPHARMA S.R.L.VIA-VIA ALCIDE DE GASPERI, 23, MELZO MI, ITALY

ESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH

DRIED FERROUS SULPHATE + FOLIC ACID

ESKAYEF BANGLADESH LTD--400, TONGI INDUSTRIAL AREA, SQUIB ROAD TONGI-GAZIPUR BANGLADESH

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

GLUCOSAMINE SULPHATE SODIUM CHLORIDE+METHYLSULPHONYLMETHANE+CHONDROITIN SULPHATE

375MG+375MG+300MG

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

Page 473: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

THIOTIC ACID 300MG EGYPT

EGYPT

ALFUZOSIN HYDROCHLORIDE 10MG EGYPT

DESLORATIDINE 0.5MG/ML EGYPT

DESLORATIDINE 5MG EGYPT

AZITHROMYCIN DIHYDRATE 250MG IRAN

AZITHROMYCIN DIHYDRATE 200MG/5ML IRAN

ACETAMINOPHEN 120MG/5ML IRAN

CEFOTAXIME 1000MG/ML IRAN

CEFTRIAXONE 1000MG IRAN

MIDAZOLAM 5MG/5ML SWITZERLAND

MIDAZOLAM 7.5MG SWITZERLAND

TRASTUZUMAB 440MG SWITZERLAND

TRASTUZUMAB 150MG SWITZERLAND

BROMAZEPAM 1.5MG SWITZERLAND

PEGINTERFERON ALPHA 2A 180MCG/2ML SWITZERLAND

BEVACIZUMAB 100 MG/ 4ML SWITZERLAND

BEVACIZUMAB 400MG/4ML SWITZERLAND

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

BENFOTIAMINE + PYRIDOXINE + CYANOCOBALAMIN

40MG + 60MG + 20MCG

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EVA PHARMA FOR PHARMACEUTICALS AND MEDICAL APPLIANCES-176 EL SADAT ST. KAFR EL GABAL, PYRAMIDS, GIZA, EGYPT

EXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRAN

EXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANEXIR PHARMACEUTICAL COMPANY-2ND KM OF RING ROAD BOROUJERED 69189 IRANEXIR PHARMACEUTICAL FACTORY-2ND KM, BORUJERD, RUF. HOFFMAN LA ROCHE LTD-CH-4070 BASELGRENZACHERSTRASSE 124, 4058 BASELF. HOFFMAN LA ROCHE LTD-CH-4070 BASELGRENZACHERSTRASSE 124, 4058 BASELF. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGST

F. HOFFMANN LA-ROCHE-WURMISWEG CH-4303 KAISERAUGSTF. HOFFMANNLA ROCHE LTD BASEL, SWITZERLAND-GRENZACHERSTRASSE 124 4070, BASEL

F.HOFFMANN- LA ROCHE LTD-CH-4070 BASEL SWITZERLANDF.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY

F.HOFFMANN-LA ROCHE LTD-GRENZACHERSTRASSE 124,CH- 4070 BASEL,ROCHE DIAGNOSTICS GMBH-SANDHOFER STRASSE 116 D-68305 MANNHEIM GERMANY

Page 474: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

3MG +1G SPAIN

SPAIN

SECNIDAZOLE 500MG FRANCE

ALBENDAZOLE 100MG/5ML FRANCE

PARACETAMOL 120MG/5ML FRANCE

ORAL REHYDRATION SALT 27.9GM INDIA

DEXAMETHASONE+GENTAMICIN 0.1%+0.3%W/V INDIA

CIPROFLOXACIN 0.3% W/V INDIA

CLOTRIMAZOLE 1%W/W INDIA

SALICYLIC ACID + BENZOIC ACID 3%W/W + 6%W/W INDIA

GENTAMICIN 0.3%W/V INDIA

FLUCONAZOLE 200MG INDIA

1%W/V + 0.1%W/V INDIA

TIMOLOL MALEATE 0.5% W/V INDIA

AZITHROMYCIN DIHYDRATE 500MG INDIA

2G + 2G + 1G +1G SPAIN

CITICOLINE 1000MG SPAIN

CITICOLINE 1000MG SPAIN

GLUTODINE (CYPROHEPTADINE ALPHA- KETOGLUTARATE) + ARGININE ASPARTATE

FAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA

TRIMETHOPRIM/SULFAMETHOXAZOLE/BROMHEXINE/SODIUM BENZOATE/TOLU BALSAM

80MG/400MG/4MG/250MG/325MG

FAES FARMA, S.A -MAXIMO AGUIRRE, 14, LEJONA 48940 VIZCAYA

FAMAR LYON-29 AVENUE CHARLES DE GAULLE SAINTFARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE

FARMACLAIR -440 AVENUE DU GENERAL DE GAULLE 14200 HEROUVILLE SAINT CLAIR FRANCE

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

DEXAMETHASONE/CHLORAMPHENICOL

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -B-8, M.I.D.C., INDUSTRIAL AREA, WALUJ – AURANGABAD- 431 136 MAHARASHTRA, INDIA.

FDC LIMITED -PLOT NO. L121 B VERNA INDUSTRIAL ESTATE VERNA SALCETE GOA 403 722

MAGNESIUM GLUTAMATE HYDROBROMIDE + AMINOBUTYRIC ACID + AMINO HYDROXYBUTYRIC ACID + VITAMIN B6

FERRER INTERNACIONAL S.A --FOR LABORATORIOS NOVAG S.A GRAN VIA CARLOS III 94 08028 BARCELONA

FERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONAFERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONA

Page 475: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CYTIDINE + URIDINE 10MG + 6MG SPAIN

CYTIDINE+URIDINE 5MG+3MG SPAIN

PREDNICARBATE 0.25%W/W SPAIN

SERTACONAZOLE NITRATE 2%W/W SPAIN

FERRING (PTY) LTD-WITTLAND II 24146 KIEL GERMANY

CARBETOCIN 100MCG/ML FERRING GMBH.-11, WITTLAND GERMANY

5MG + 10MG INDIA

ATORVASTATIN 20MG INDIA

ATORVASTATIN CALCIUM 10MG INDIA

ATORVASTATIN CALCIUM 40MG INDIA

CARVEDILOL 12.5 MG INDIA

CARVEDILOL 25MG INDIA

INDIA

22MG + 7.5MG INDIA

FERRER INTERNACIONAL S.A --GRAN VIA CARLOS III 94 08028 BARCELONAFERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN

FERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN

FERRER INTERNACIONAL, S.A-JOAN BUCSALA 1-9, 08173 SANT CUGAT DEL VALLES, BARCELONA, SPAIN

HIGHLY PURIFIED MENOTROPHIN [ CORRESPONDING TO FOLLICLE STIMULATING HORMONE ACTIVITY (FSH) 75 IU + LUTEINISING HORMONE ACTIVITY (LH) 75 IU]

75 IU + 75 IU/ 4ML VIAL

LEVOCETIRIZINE HYDROCHLORIDE + MONTELUKAST SODIUM

FOURRTS (INDIA) LABORATORIES (PVT) LTD-FOURRTS AVENUE, VANDALUR ROAD

FOURRTS (INDIA) LABORATORIES PVT LTD -PALE YELLOW COLOURED CIRCULAR, UNCOATED TABLET WITH A BREAKLINE ON ONE SIDE

FOURRTS (INDIA) LABORATORIES PVT LTD -PALE YELLOW COLOURED CIRCULAR, UNCOATED TABLET WITH A BREAKLINE ON ONE SIDE

FOURRTS (INDIA) LABORATORIES PVT LTD -PALE YELLOW COLOURED CIRCULAR, UNCOATED TABLET WITH A BREAKLINE ON ONE SIDE

FOURRTS (INDIA) LABORATORIES PVT LTD -PALE YELLOW COLOURED CIRCULAR, UNCOATED TABLET WITH A BREAKLINE ON ONE SIDE

FOURRTS (INDIA) LABORATORIES PVT LTD -PALE YELLOW COLOURED CIRCULAR, UNCOATED TABLET WITH A BREAKLINE ON ONE SIDE

IRON PENTACARBONYL + ZINC SULPHATE MONOHYDRATE + FOLIC ACID + SODIUM SELENITE + LYSINE HYDROCHLORIDE + HISTIDINE HYDROCHLORIDE + CHOLINE BITARTRATE

100MG + 30MG + 7.5MG + 0.11MG + 26MG + 4.4MG + 52MG

FOURRTS (INDIA) LABS PVT LTD .-VANDALUR ROAD. KELAMBAKK AM-603103 TAMIL, INDIA

POTASSIUM CITRATE + MAGNESIUM CITRATE

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

Page 476: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SUCRALFATE + OXETACAINE 10MG + 0.2MG INDIA

INDIA

MISOPROSTOL 200MCG INDIA

GRISEOFULVIN 500 MG INDIA

METFORMIN 500 INDIA

DICLOFENAC 50 INDIA

MEBENDAZOLE 100MG INDIA

5MG+500MG INDIA

IBUPROFEN 400MG INDIA

CO-TRIMOXAZOLE TABLETS BP 960MG INDIA

INDIA

CHLORAMPHENICOL 250MG INDIA

PROMETHAZINE HYDROCHLORIDE 25MG INDIA

INDIA

NALIDIXIC ACID 500MG INDIA

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

THIAMINE +RIBOFLAVIN + PYRIDOXINE + NICOTINAMIDE + FOLIC ACID + ASCORBIC ACID + COLECALCIFEROL + ACETYL CYSTEINE + GLYCINE + GLUTAMIC ACID + CHROMIUM + VANADIUM + ZINC + SELENIUM

10MG + 10MG + 3MG + 50MG + 1MG + 75MG + 400IU + 25MG +25MG +MG +200MCG + 100MCG + 55MG +100MCG

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

FOURRTS INDIA LABORATORIES PVT. LIMITED-VANDALUR ROAD, KELAMBAKKAM 603103, CHENNAI, TAMIL NADU, INDIA

FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,TAMIL NADU,INDIA

GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE

FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,TAMIL NADU,INDIA

FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,TAMIL NADU,INDIA

FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,TAMIL NADU,INDIA

CHLORHEXIDINE+METRONIDAZOLE+LIDOCAINE

5%W/W+1.61%W/W+2.13%W/W

FOURRTS(INDIA) LABORATORIES PVT.LIMITED-VANDALUR ROAD,KELAMBAKKAM-603 103,TAMIL NADU,INDIA

FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD

PARACETAMOL + IBUPROFEN + CAFFEINE

325MG + 200MG + 40MG

FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROADFOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD

Page 477: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

5MG + 500MG INDIA

METFORMIN 850MG INDIA

GLIPIZIDE 5MG INDIA

METFORMIN 500MG INDIA

PARACETAMOL 500MG INDIA

FUROSEMIDE 40MG INDIA

AMINOPHYLLINE 100MG INDIA

PROPOFOL 1% W/V AUSTRIA

PARACETAMOL 10MG/ML AUSTRIA

KETAMINE HYDROCHLORIDE 50MG/ML

LIGNOCAINE HYDROCHLORIDE 2%W/V

MANNITOL 20%W/V

NALOXONE HYDROCHLORIDE 0.02MG/ML

NALOXONE HYDROCHLORIDE 0.4MG/1ML

NEOSTIGMINE METHYLSULPHATE 2.5MG\ML

PANCURONIUM BROMIDE 4MG/2ML

PARACETAMOL + PHENYLEPHRINE +CHLORPHENIRAMINE + CAFFEINE

500MG + 5MG + 2MG + 30MG

FOURTS (INDIA) LABORATORIES PRIVATE LIMITED -VANDALUR ROAD

GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE

FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA

FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA

FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA

FREDUN PHARMACEUTICALS LIMITED---14,15,16 ZORABIAN INDUSTRIAL COMPLEX PALAGHAR (EAST), DIST THANE 401 404 INDIA

FREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA

FREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA

FREDUN PHARMACEUTICALS LTD-14,15,16 ZORBIAN INDUSTRIAL COMPLEX VEOOR PALGHAR EAST INDIA

FRESENIUS KABI AUSTRIA GMBH PLANT GRAZ-HAFNERSTRASSE 36 A-8055 GRAZ AUSTRIA,FRESENIUS KABI AB PLANT UPPSALA-RAPSGATAN 7S-75174 UPPSALA SWEDEN

FRESENIUS KABI AUSTRIA GMBH-AUSTRIA GMBH HAFNERSTRASSEM 36 8055 GRAZ

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

Page 478: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FENTANYL 100MCG/2ML

FENTANYL CITRATE 500MCG/10ML

MORPHINE SULPHATE 10MG/ML

MORPHINE SULPHATE 15MG/ML

DOPAMINE HYDROCHLORIDE 200MG/5ML

DICLOFENAC DIETHYLAMINE 1.16%W/W INDIA

POVIDONE IODINE 5%W/W INDIA

POVIDONE IODINE 5%W/V INDIA

POVIDONE-IODINE 5%W/W INDIA

LACTULOSE 10G/15ML INDIA

POVIDONE IODINE 2%W/V INDIA

HYDROCORTISONE 1%W/W INDIA

CHLORHEXIDINE 4%W/W INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

CLOTRIMAZOLE 1%W/W INDIA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESENIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD, KORSTEN 6020, PORT ELIZABETH

SOUTH AFRICA

FRESNIUS KABI MANUFACTURING SA (PTY) LTD-6 GIBAUD ROAD KORSTEN PORT ELIZABETH 6020

SOUTH AFRICA

G,S PHARMBUTOR PVT LTD -B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN

G.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA

G.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA

G.S PHAMBUTOR PVT LTD .-B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA

G.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA

G.S PHAMBUTOR PVT LTD-G.S PHAMBUTOR PVT LTD B-172 RIICO IND ,BEHOR 301701 DIST ALWAR RAJASTHAN INDIA

GALENTIC PHARMA PVT LIMITED-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI MUMBAI

GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701INDIA

GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701INDIA

GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701INDIA

Page 479: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NYSTATIN 100,000I.U INDIA

BETAMETHASONE VALERATE 0.1%W/V INDIA

HYDROCORTISONE ACETATE 1%W/W INDIA

BENZYL BENZOATE 25%W/W INDIA

ACICLOVIR 5%W/W INDIA

TETRACYCLINE 1%W/W INDIA

INDIA

BENZOIC ACID + SALICYLIC ACID 6 %W/W + 3 %W/W INDIA

CALAMINE 15 %W/W INDIA

BETAMETHASONE 0.1%W/W INDIA

INDIA

BENZOIC ACID + SALICYLIC ACID 6%W/W + 3%W/W INDIA

CIPROFLOXACIN HYDROCLORIDE 500MG INDIA

IRON + FOLIC ACID INDIA

AMOXICILLIN + CLAVULANATE 1000 MG + 200 MG INDIA

GALENTIC PHARMA PVT. LIMITED -R-673, TTC MIDC, RUBALE, THANE BELAPUR NAVI MUMBAI 400 701INDIA

GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701INDIA

GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701INDIA

GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE BELAPURNAVI MUMBAI 400 701INDIA

GALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIAGALENTIC PHARMA PVT. LIMITED-R-673, TTC MIDC, RUBALE, THANE, INDIA

NEOMYCIN+ POLYMYXIN B +BACITRACIN

3.4%W/W + 5%W/W + 0.4%W/W

GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI

GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI

GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI

GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI

BETAMETHASONE + PHENYLEPHRINE + LIDOCAINE

O.5 MG/G + 1 MG/G + 25 MG/G

GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI

GALENTIC PHARMA( INDIA ) PVT LTD-R-673,MIDC TTC RABALE THANE-BELAPUR ROAD,NAVI

GALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDISOLAN HIMACHAL PRADESH-173 205 INDIA

50MG + 0.5MG /5ML

GALPHA LABORATORIES LIMITED-VILLAGE – THANA BADDI, TEHSIL BADDISOLAN HIMACHAL PRADESH-173 205 INDIA

GALPHA LABORATORIES LTD-AT: ALKEM LABORATORIES LTD PLOT 167/2 MAHATMA UDYOG NAGAR AMALIYA DAMAN 396210

Page 480: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SODIUM FUSIDATE 20MG/G INDIA

CINNARAZINE 25MG INDIA

INDIA

FLUNARIZINE 5MG INDIA

25MG/ML INDIA

DIAZEPAM 10MG INDIA

OXYTOCIN 10IU/ML INDIA

OXYTOCIN 10IU INDIA

ZOLEDRONIC ACID 5MG/100ML INDIA

MAGNESIUM SULPHATE 50MG/ML INDIA

QUININE DIHYDROCHLORIDE 300MG/ML INDIA

FUROSEMIDE 10MG/ML INDIA

DIGOXIN 0.25MG/ML INDIA

GENTAMYCIN SULPHATE 40MG/ML INDIA

PARAMOMYCIN 375MG/ML INDIA

HYOSCINE BROMIDE 2OMG/ML INDIA

GENO PHARMACEUTICALS LIMITED-KARASWADA,MAPUSAGENO PHARMACEUTICALS LTD. -TIVIM INDUSTRIAL ESTATE, KARASWADA, MAPUSA, GOA

DICLOFENAC/PARACETAMOL/CHLORZOXAZONE

50MG/325MG/250MG

GENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526

GENO PHARMACEUTICALS LTD--PHARMACEUTICAL COMPLEX, TIVIM INDUSTRIAL ESTATE, P.O. KARASWADA, MAPUSA, GOA 403526

CHLORPROMAZINE HYDROCHLORIDE

GLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD – 500 043, INDIA

GLAND PHARMA LIMITED-D. P PALLY NARSAPUR ROAD, HYDERABAD – 500 043, INDIA

GLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA

GLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA

GLAND PHARMA LIMITTED 143-148-D P PALLY, QUTHUBULLAPUL MANDAL, RANDA REDDY DIST, HYBERABAD, IN-500 043, INDIA

GLAND PHARMA LIMITTED 143-148-SURVEY NOS. 143-148, 150&151, NEAR GANDIMAISAMMA CROSS ROADS. RANGA REDDY DISTRICT HYDERABAD 500043

GLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&

GLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&GLAND PHARMA LTD .-D.P. PALLY, SURVEY 143-148, 150&GLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043

GLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043

GLAND PHARMA LTD -D.P PALLY DUNDIGAL POST QUTBULLAPUR MANDAL RANGA REDDY DISTRICT HYDERABAB 500043

Page 481: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LIDOCAINE HCL 5%+DEXTROSE 7.5% 50MG +75MG/ML INDIA

METHYLERGOMETRINE 0.2MG/ML INDIA

METHYLERGONOVINE MALEATE 0.2MG/ML INDIA

ARTEMETHER 80MG/ML INDIA

5MG/ML INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

FUROSEMIDE 20MG/2ML INDIA

DIAZEPAM 5MG/ML INDIA

ABACAVIR SULFATE + LAMIVUDINE 600 MG + 300 MG

MUPIROCIN 2%W/W

MUPIROCIN 2%W/W

FLUTICASONE FUROATE

100MCG + 25MCG

GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH

GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH

GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH

GLAND PHARMA LTD -D.P.PALLY, DUNDIGAU POST NEAR GANDIMAISAMMA CROSS ROAD, QUTHBULLAPUR MANDAL, RANGA REDDY DISTRICT, HYDERABAD - 500043, ANDHRA PRADESH

METOCLOPRAMIDE HYDROCHLORIDE

GLAND PHARMA LTD -DOMMARA POCHAMPALLY SURVEY NO. 5GLAND PHARMA LTD -DOMMARA POCHAMPALLY SURVEY NO. 5GLAND PHARMA LTD -GLAND PHARMA LTD D.P PALLY DUNDIGAL HYDERABADGLAND PHARMA LTD.-GLAND PHARMA LTD, D.P. PALLY, SURVEY NO. 143,150 &

DOLUTEGRAVIR + ABACAVIR + LAMIVUDINE

50MG + 600MG + 300MG

GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)-PRIORY STREET, WAREHERTFORDSHIRE SG12 0DJ, UK

UNITED KINGDOM

GLAXO OPERATIONS UK LTD -PRIORY STREET, WAREHERTFORDSHIRE SG12 0DJ, UK

UNITED KINGDOM

GLAXO OPERATIONS UK LTD -PRIORY STREET, WAREHERTFORDSHIRE SG12 0DJ, UK

UNITED KINGDOM

GLAXO OPERATIONS UK LTD -PRIORY STREET, WAREHERTFORDSHIRE SG12 0DJ, UK

UNITED KINGDOM

27.5MCG/ACTUATION

GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK

UNITED KINGDOM

FLUTICASONE FUROATE + VILANTEROL

GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK

UNITED KINGDOM

Page 482: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

200MCG + 25MCG

CHLORHEXIDINE 4%W/W

DOLUTEGRAVIR SODIUM 50MG

MULTI-INGREDIENT MULTI-INGREDIENT

20DOSES BELGIUM

MEASLES + MUMPS + RUBELLA BELGIUM

RANITIDINE 50MG/2ML ITALY

ATRACURIUM BESYLATE 10MG/ML ITALY

SALBUTAMOL 2MG/ML GLAXO WELLCOME -- LIKONI KENYA KENYA

MULTINGREDIENT GLAXO WELLCOME (KENYA) LTD-KENYA KENYA

CHLORPHENIRAMINE MALEATE 4MG GLAXO WELLCOME (KENYA) LTD-KENYA KENYA

FLUTICASONE PROPIONATE 0.05%W/W GLAXO WELLCOME (UK)-UK

FLUTICASONE PROPIONATE 0.005%W/W GLAXO WELLCOME (UK)-UK

GLAXO WELLCOME EGYPT CO. S.A.E-CAIRO EGYPT

CO-TRIMOXAZOLE 480MG GLAXO WELLCOME EGYPT CO. S.A.E-CAIRO EGYPT

CHLORZOXANE/PARACETAMOL 250MG/300MG EGYPT

EGYPT

1.25MG/30MG EGYPT

VINCAMINE 30MG EGYPT

LAMOTRIGINE 2MG

FLUTICASONE FUROATE + VILANTEROL

GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK

UNITED KINGDOM

GLAXO OPERATIONS UK LTD---HARMIRE ROAD, BARNARD CASTLE, DURHAM DL128 DT UK

UNITED KINGDOM

GLAXO OPERATIONS UK LTD-WARE SG120DJ UNITED KINGDOM

UNITED KINGDOM

GLAXO SMITH KLINE LTD-LIKONI RD, INDUSTRIAL AREA,NAIROBI KENYA,GLAXOSMITHLINE-CAPE TOWN, S.A

SOUTH AFRICA

BIVALENT ORAL POLOIMYELITIS VACCINE TYPES 1 & 3 ( BOPV)

GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART

103.0CCID50 + 103.7CCID50 + 103.0CCID50

GLAXO SMITHKLINE BIOLOGICALS S.A-RUE DE L'INSTITUT, 89 B-1330 RIXENSART

GLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA)

GLAXO SMITHKLINE MANUFACTURING S.P.A .-STARDA PROVINCIALE ASOLANA 90, 43056 SAN POLO DI TORRILE (PARMA),GLAXOSMITHKLINE SPA FLEMING -2, 37135 PARMA

CHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDE

UNITED KINGDOMUNITED KINGDOM

TRIMETHOPRIM + SULPHAMETHOXAZOLE

40MG/5ML + 200MG/5ML

GLAXO WELLCOME EGYPT CO. S.A.E-CAIRO,GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO

TRIPLORIDINE HCL/PSEUDOEPHEDRINE/GUAIPHENESIN

1.25MG/30MG/100MG

GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIRO

TRIPLORIDINE HCL/PSEUDOEPHEDRINE

GLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROGLAXO WELLCOME EGYPT SAE.-EL SALAM CITY 11491, CAIROGLAXO WELLCOME INC-ZI DE LA PEYENNIERE, 53100, MAYENNE

UNITED STATES

Page 483: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXYCILLIN 500MG

2.5MG+60MG EGYPT

EGYPT

SALBUTAMOL 100MCG FRANCE

AMOXYCILLIN 250MG FRANCE

600MG + 42.9MG FRANCE

1000MG + 125MG FRANCE

AMOXYCILLIN 125MG/5ML

AMOXYCILLIN 250MG/5ML FRANCE

25/50 MCG FRANCE

FLUTICASONE PROPIONATE 250MCG FRANCE

FLUTICASONE PROPIONATE 500MCG FRANCE

FRANCE

FLUTICASONE PROPIONATE 100MCG FRANCE

ROPINIROLE 2MG SPAIN

ROPINIROLE 4MG SPAIN

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

UNITED KINGDOM

TRIPROLIDINE HYDROCHLORIDE+PSEUDOPHEDRINE HYDROCHLORIDE

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

TRIPROLIDINE HYDROCHLORIDE+PSEUDOEPHEDRINE HYDROCHLORIDE+DEXTROMETHORPHAN

1.25MG+30MG+10MG

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE

GLAXO WELLCOME PRODUCTION -Z.I DE LA PEYENNIERE 53100 MAYENNE FRANCE

GLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE

UNITED KINGDOM

GLAXO WELLCOME PRODUCTION.-ZONE INDUSTRIELLE DE LA PEYENNIERE 53100 MAYENNE, FRANCE

SALMETEROL/ FLUTICASONE PROPIONATE

GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX

GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX

GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX

SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE

120 METERED DOSES (25/125MCG)

GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX

GLAXO WELLCOME PRODUCTION-ZONE INDUSTRIELLE NO.2 23 RUE LAVOISER 27000 EVREUX

GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS

GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS

Page 484: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ATOVAQUONE + PROGUANIL 62.5 MG + 25.0 MG SPAIN

ATOVAQUONE + PROGUANIL HCL 250MG + 100MG SPAIN

FLUTICASONE PROPIONATE 50MCG SPAIN

FLUTICASONE PROPIONATE 125MCG SPAIN

ROPINIROLE 8MG SPAIN

CEFUROXIME SODIUM 750MG GLAXO WELLCOME -VERONA ITALY ITALY

25MCG + 250MCG FRANCE

HEPATITIS B SURFACE ANTIGEN 20MCG/ML BELGIUM

BELGIUM

BELGIUM

BELGIUM

HEPATITIS B SURFACE ANTIGEN 10MCG/ML BELGIUM

ROTAVIRUS VACCINE LIVE BELGIUM

GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS

GLAXO WELLCOME S.A ARANDA-ARANDA AVDA EXTREMADURA 3, 09400 ARANDA DE DUERO BURGOS

GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 309400 ARANDA DE DUEROBURGOSSPAIN

GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 309400 ARANDA DE DUEROBURGOSSPAIN

GLAXO WELLCOME S.A.-AVENIDA DE EXTREMADURA 309400 ARANDA DE DUEROBURGOSSPAIN

SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE

GLAXO WELLCOME-PRODUCTION ZONE INDUSTRIELLE NO. 2 23, RUE LAVOISIER 27000 EVREUX

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE PROTEIN D VACCINE

1 DOSE (0.5ML), 2DOSES (1.0ML)

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

HEPATITIS A ANTIGEN (INACTIVATED) + HEPATITIS B SURFACE ANTIGEN

720 ELISA UNITS + 20MCG

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

DIPHTHERIA + PERTUSSIS + BORDETELLA/PERTUSSIS + PERTUSSIS + HAEMAGGLUTININ + PERTACTIN + (HEPATITIS B/POLIOVIRUS TYPE 1 +2 +3)

NLT 30 IU + NLT 40IU + 25MCG + 25MCG + 8MCG + 10MCG + (TYPE I 40D +TYPE 2 + TYPE 3)

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

NLT 10 TO POWER 6 CCID50

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

Page 485: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FRANCE

CLOBETASOL PROPIONATE 0.05%W/W

CLOBETASOL PROPIONATE 0.05%W/W

BETAMETHASONE VALERATE 0.1%W/W

BETAMETHASONE VALERATE 0.1%W/W

RANITIDINE 150MG KENYA

MULTI-INGREDIENT N/A KENYA

RANITIDINE 150MG KENYA

MULTI-INGREDIENT N/A KENYA

PARACETAMOL 500MG KENYA

PARACETAMOL + CAFFEINE 500MG + 65MG KENYA

PARACETAMOL 120MG/5ML KENYA

CEFTAZIDIME 1GM ITALY

REMIFENTANIL 2MG ITALY

CEFTRIAXONE 1G ITALY

REMIFENTANIL 3MG ITALY

REMIFENTANIL 1ML ITALY

HUMAN PAPILLOMA VIRUS VACCINE (RDNA)

TYPE 16 L1 PROTEIN + TYPE 18 L1 PROTEIN + 3-0-DESACYL-4'MONOPHOSPHORYL LIPID A(MPL)

GLAXOSMITHKLINE BOILOGICALS-S.A RUE DE I'INSTITUT 89 B-1330 RIXENSART

GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM

UNITED KINGDOM

GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM

UNITED KINGDOM

GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM

UNITED KINGDOM

GLAXOSMITHKLINE HARMIRE -GLAXOSMITHKLINE HARMIRE ROAD BARNARD CASTLE DURHAM

UNITED KINGDOM

GLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYA

GLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYA

GLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYA

GLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYA

GLAXOSMITHKLINE LIKONI ROAD IND-AREA, NAIROBI, BETA HEALTHCARE INTERNATIONAL LTD PLOT NO. LR 209/6554 MOGADISHU ROAD, INDUSTRIAL AREA, NAIROBI, KENYA

GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYA

GLAXOSMITHKLINE LIMITED - -78392-00507, VIWANDANI LIKONI ROAD NAIROBI KENYAGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONAGLAXOSMITHKLINE LTD MANUFACTURING SPA-VERONA

Page 486: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DUTASTERIDE 0.5MG POLAND

CISATRACURIUM BESYLATE 2MG/ML ITALY

ALBENDAZOLE 400MG

CEFUROXIME AXETIL- 125MG/5ML

CEFUROXIME AXETIL 250MG/5ML

CEFUROXIME AXETIL 250MG

CEFUROXIME AXETIL 500MG

CEFUROXIME AXETIL 250MG

CEFUROXIME AXETIL 500MG

CEFUROXIME AXETIL 125MG/5ML

CALCITRIOL 0.0003% W/W INDIA

INDIA

INDIA

GLAXOSMITHKLINE PHARMACEUTICALS SA .-GRUNWALDZKA 189 STREET, 60-322 POZNANA

GLAXOSMITHKLINE S.P.A -STRADA PROVINCIALE ASOLANA 9GLAXOSMITHKLINE SOUTH AFRICA (PTY) LTD-39 HAWKINS AVENUE, EPPING INDUSTRIAL, CAPE TOWN, 7460, SOUTH AFRICA

SOUTH AFRICA

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLAXOSMITHKLINE UK LTD-HARMIRE RD BARNARD CASTLE DURHAM, DL12DT UNITED

UNITED KINGDOM

GLENMARK PHARMACEUTICALS LIMITED, AT: (UNIT II)-VILLAGE BHATTANWALA, P.O. RAJPURA,NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH, 174 101, INDIA

SALMETEROL XINAFOATE/ FLUTICASONE PROPIONATE

25MCG+125MCG/ACTUATION

GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA

SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE

25MCG+50MCG/ACTUATION

GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA

Page 487: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10 MG + 5 MG INDIA

INDIA

LORNOXICAM 8MG INDIA

LORNOXICAM 16MG INDIA

LORNOXICAM + PARACETAMOL 4MG + 500MG INDIA

LORNOXICAM + PARACETAMOL 8MG + 500MG INDIA

BECLOMETASONE INDIA

BECLOMETASONE INDIA

BECLOMETASONE INDIA

MONTELUKAST SODIUM+LEVOCETIRIZINE DIHYDROCHLORIDE

GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA

SALMETEROL XINAFOATE/FLUTICASONE PROPIONATE

25MCG+250MCG/ACTUATION

GLENMARK PHARMACEUTICALS LIMITED-UNIT-I, VILLAGE KISHANPURA, BADDI, NALAGARH ROAD, TEHSIL NALAGARH ,HIMACHAL PRADESH 174 101, MAHARASHTRA STATE, INDIA

GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA

GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA

GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA

GLENMARK PHARMACEUTICALS LTD - UNIT III-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -174 101 INDIA

50MCG PER ACTUATION

GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA

200MCG PER ACTUATION

GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA

250MCG PER ACTUATION

GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA

Page 488: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BECLOMETHASONE INDIA

SALBUTAMOL + BECLOMETASONE INDIA

LEVOFLOXACIN 500MG INDIA

100MG + 500MCG INDIA

IRON(111) POLYMALTOSE COMPLEX 50MG/5ML INDIA

INDIA

CALCIUM CITRATE + VITAMIN D3 1000MG +200 I.U INDIA

CLOTRIMAZOLE 100MG INDIA

CLOTRIMAZOLE 2%W/W INDIA

100MCG PER ACTUATION

GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA

100MCG/ACTUATION + 50MCG/ACTUATION

GLENMARK PHARMACEUTICALS LTD (UNIT III).-UNIT III VILLAGE KISHANPURA,BADDI-NALAGARH ROAD TEHSIL BADDI,DISTT. SOLAN, HIMACHAL PRADESH -173 205 INDIA

GLENMARK PHARMACEUTICALS LTD (UNIT III)-B-4/5/6 MIDC INDUSTRIAL AREA,CHIKALTHANA 431210 DIST AURANGABAD MAHARASHTRA

IRON (111) POLYMALTOSE COMPLEX + FOLIC ACID

GLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA

GLENMARK PHARMACEUTICALS LTD PLOT E-PLOT NO. E-37, 39, MIDC AREA, SATPUR, NASIK - 422 007, MAHARASHTRA

FUSIDIC ACID+MOMETASONE FUROATE

2.1%W/W + 0.1W/W

GLENMARK PHARMACEUTICALS LTD UNIT II.-UNIT II VILLAGE BHATTANWALA NALAGARH DIST SOLAN HIMACHAL PRADESH

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

Page 489: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LINEZOLID 600MG INDIA

INDIA

KETOCONAZOLE/ZINC PYRITHIONE 1%W/V+2%W/V INDIA

ITRACONAZOLE 100MG INDIA

MUPIROCIN 2%W/W INDIA

INDIA

INDIA

1% + 0.025% INDIA

CLOTRIMAZOLE 1%W/W INDIA

LEVOFLOXACIN 500MG INDIA

ADAPALENE 0.1%W/W INDIA

ESOMEPRAZOLE 20MG INDIA

ESOMEPRAZOLE 40MG INDIA

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

BROMHEXINE+MENTHOL+TERBUTALINE+GUAIFENESIN

2MG+0.5MG+1.25MG+50MG

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

BECLOMETASONE/CLOTRIMAZOLE/GENTAMYCIN

0.025%W/W+1%W/W+0.1%W/W

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

CLOTRIMAZOLE + BECLOMETASONE DIPROPRIONATE CREAM

1%W/W + 0.025%W/W

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

CLOTRIMAZOLE + BECLOMETHASONE DIPROPIONATE

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

Page 490: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

CLOTRIMAZOLE 1%W/W INDIA

BUTENAFINE HCL 1%W/W INDIA

CLOBETASOL 0.05%W/W INDIA

CLOTRIMAZOLE 500MG INDIA

CLOTRIMAZOLE 1%W/W INDIA

INDIA

MONTELUKAST 4MG INDIA

MONTELUKAST 5MG INDIA

50MCG/140MCG INDIA

50MCG/ SPRAY INDIA

LISINOPRIL 10MG EGYPT

TIOCONAZOLE 1%W/W EGYPT

LISINOPRIL 5MG EGYPT

TENOXICAM 20MG EGYPT

DESLORATADINE 5MG EGYPT

MARAVIROC 300MG GERMANY

125MG+1MG/5ML INDIA

325MG/37.5MG INDIA

ALUMINIUM HYDROXIDE/MAGNESIUM HYDROXIDE/DIMETHICONE/LIQUORICE

6G+80MG+100MG+400MG/5ML

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

GLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,DGLENMARK PHARMACEUTICALS LTD-PLOT NO E -37, 39 ,D

SALBUTAMOL+BROMOHEXINE HYDROCHLORIDE+GUAIFENESIN

2MG+4MG+100MG/10ML

GLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIAGLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA

GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA

MOMETASONE FUROATE / AZELASTINE HYDROCHLORIDE

GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA

MOMETASONE FUROATE MONOHYDRATE

GLENMARK PHARMACEUTICALS LTD-VILLAGE: KISHANPURA, BADDI NALAGARH DISTRICT SOLAN - 174101, INDIA,GLENMARK PHARMACEUTICALS LTD-VILLAGE, KISHANPURA, BADDI, NALAGARH ROAD, INDIA

GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA,

GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA,

GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA,

GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA,

GLOBAL NAPI PHARMACEUTICALS -2ND INDUSTRIAL ZONE, NO.40, ST. NO 18, 6TH OCTOBER, GIZA,

GODECKE GMBH -MOOSWALDALLEE 179090, FREIBERG GERMANY

PARACETAMOL+CHLORPHENIRAMINE MALEATE

GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)

PARACETAMOL/TRAMADOL HYDROCHLORIDE

GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)

Page 491: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IBUPROFEN+METHOCARBAMOL 200MG+500MG INDIA

ALBENDAZOLE 200 MG / 5 ML INDIA

KETOCONAZOLE 2%W/W INDIA

INDIA

CELECOXIB 200MG INDIA

GENTAMYCIN SULPHATE 40MG/ML CHINA

CALCIUM GLUCONATE INJECTION 1G/10ML CHINA

GENTAMICIN 80MG/2ML CHINA

DICLOFENAC SODIUM 75MG CHINA

40MG +320MG CHINA

CEFTRIAXONE 1G CHINA

20MG/160MG CHINA

80MG/640MG CHINA

MOXIFLOXACIN HYDROCHLORIDE 400 MG CHINA

ARTEMETHER 80MG/ML CHINA

ARTESUNATE 30MG CHINA

GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)

GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)

GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)

PARACETAMOL+DEXTROMETORPHAN HYDROBROMIDE+CHLORPHENAMINE MALEATE

125MG+5MG+1MG/5 ML

GRACURE PHARMACEUTICAL LTD-E-1105, RIICO IND. AREA, PHASE III, BHIWADI, DISTRICT ALWAR (RAJASTHAN)

GRACURE PHARMACEUTICALS LIMITED -E- 1105, RIICO INDUSTRIAL AREA, PHASE-III BHIWADI, PIN-301019 DIST. ALWAR, RAJASTHAN, INDI

GRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE.

GRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCE

GRAND PHARMACEUTICAL(CHINA) CO.LTD-NO.5 GUTIAN ROAD QIAOKOU DISTRICT WUHAN CITY HUBEI PROVINCE

GUILIN PHARMACEUTICAL CO LTD--NO. 43 QILIDIAN ROAD GUILIN 541004 GUANGXI

DIHYDROARTEMESININ + PIPERAQUINE PHOSPHATE

GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI

GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI

DIHYDROARTEMISININ/PIPERAQUINE

GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI

DIHYDROARTEMESININ/PIPERAQUINE PHOSPHATE

GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI

GUILIN PHARMACEUTICAL CO LTD-NO.43 QILIDIAN ROAD GUILIN 541004 GUANGXI

GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI

GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI

Page 492: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTESUNATE 120MG CHINA

ARTESUNATE 60 MG CHINA

40MG/320MG CHINA

CIPROFLOXACIN 500MG CHINA

800MG /160MG CHINA

400MG /80MG CHINA

ARTESUNATE+AMODIAQUINE 50MG+135MG CHINA

ARTESUNATE + AMODIAQUINE 25 MG + 67.5 MG CHINA

ARTESUNATE + AMODIAQUINE 100 MG + 270 MG CHINA

METRONIDAZOLE TABLETS BP 200MG CHINA

B-SITOSTEROL 0.25%W/W

IRON SUCROSE 20MG/ML

CEFUROXIME SODIUM 750MG

GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI

GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI

DIHYDROARTEMESININE/ PIPERAQUINE PHOSPHATE

GUILIN PHARMACEUTICAL CO.,LTD-NO 43 QILIDIAN ROAD GUILIN 541002, GUANGXI

GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA

SULFAMETHOXAZOLE / TRIMETHOPRIM

GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA

SULFAMETHOXAZOLE / TRIMETHOPRIM

GUILIN PHARMACEUTICAL CO.LTD.-NO.43 QUILIDIAN ROAD GUILIN 541002, GUANGXI, CHINA

GUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA

GUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA

GUILIN PHARMACEUTICALS CO. LTD-NO 43 SHANGHAI ROAD GUILIN GUANGXI CHINA

GUILIN PHARMACEUTICALS CO. LTD-NO.7 SHANGHAI ROAD GUILIN 541002, GUANGXI, CHINA

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX:997,RAS AL KHAIMAH,U.A.E.

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX:997,RAS AL KHAIMAH,U.A.E.

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD, DIGDAGA, P.O.BOX:997,RAS AL KHAIMAH,U.A.E.

UNITED ARAB EMIRATES

Page 493: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ASPIRIN 81MG

215MG+80MG/5ML

OMEPRAZOLE 20MG

PARACETAMOL+CAFFEINE 500MG+65MG

MOMETASONE FUROATE 0.1%W/W

MOMETASONE FUROATE 0.1%W/W

DEXPANTHENOL 0.05%W/W

1MG +1MG

CEFUROXIME AXETIL 500MG

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

ALUMINIUM HYDROXIDE +MAGNESIUM HYDROXIDE

405 MG+100 MG/ 5ML

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

DRIED ALUMINIUM HYDROXIDE GEL+MAGNESIUM HYDROXIDE+SIMETHICONE

200MG+200MG+25MG

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

DIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL

7MG+28.5MG+0.55 MG/5 ML

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

NYSTATIN+NEOMYCIN SULFATE+GRAMICIDIN+TRIAMCINOLONE

10,000,000I.U+2.5MG+0.25MG+1MG

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

CETYLPYRIDINIUM CHLORIDE + LIDOCAINE HYDROCHLORIDE

GULF PHARMACEUTICAL INDUSTRIES (JULPHAR)-AIRPORT ROAD,DIGDAGA STREETRAS AL KHAIMAH

UNITED ARAB EMIRATES

GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E

UNITED ARAB EMIRATES

Page 494: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

VANCOMYCIN HYDROCHLORIDE 1G

METFORMIN HYDROCHLORIDE 1000MG

FLUCONAZOLE 150MG

GLIMEPIRIDE 3MG

CEFTRIAXONE 0.5G

IBANDRONIC ACID 150MG SWITZERLAND

ZUCLOPENTHIXOL ACETATE 50MG/ML H. LUNDBECK A/S - OTTILIAVEJ 9,2500 VALBY DENMARK

ZUCLOPENTHIXOL DECANOATE 200MG/ML DENMARK

FLUPENTIXOL DECANOATE 20MG/ML DENMARK

ANASTROZOLE 1MG GERMANY

AZITHROMYCIN DIHYRATE 200MG/5ML

AZITHROMYCIN DIHYDRATE 500MG

AMPICILLIN + SULBACTAM 1000 MG + 500 MG ITALY

375MG ITALY

LETROZOLE 2.5MG GERMANY

DICLOFENAC SODIUM 100MG GERMANY

GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E

UNITED ARAB EMIRATES

GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E

UNITED ARAB EMIRATES

GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E

UNITED ARAB EMIRATES

GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E

UNITED ARAB EMIRATES

GULF PHARMACEUTICALS INDUSTRIES"JULPHAR"-P.O.BOX 997 AIRPORT ROAD,DIGDAGA STREET RAS AL KHAIMAH,U.A.E

UNITED ARAB EMIRATES

H. HOFFMAN ROCHE-GRENZACHERSTRASE 124, EXT 4070, BASEL SWITZERLAND & CH-4303 KAISERANGST SWITZERLAND

H. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN

H. LUNDBECK A/S ,.,-OTTILIAVEJ 9, DK-2500, VALBY-COPENHAGEN

HAUPT PHARMA GMBH & CO KG-SCHLEEBRUGGENKAMP 15, 48159 MUNSTER, GERMANY

HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE

SOUTH AFRICA

HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE

SOUTH AFRICA

HAUPT PHARMA LATINA S.R.L LATINA-SS 156KM 47,600-04100,BORGO SAN,MICHELE

SULTAMICILLIN TOSYLATE DIHYDRATE

HAUPT PHARMA LATINA S.R.L -S.S 156 KM BORGO SAN MICHELE LATINAHAUPT PHARMA MÜNSTER GMBH-SCHLEEBRÜGGENKAMP 1548159 MÜNSTERGERMANY

HAUPT PHARMA WULFING GMBH.-BETHELNER LANDSTR. 18, 31028 GRONAU

Page 495: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFUROXIME AXETIL 250MG BANGLADESH

PARACETAMOL 500MG CHINA

PARACETAMOL 500MG CHINA

ABACAVIR SULPHATE 300MG INDIA

INDIA

200MG/300MG INDIA

CAPECITABINE 150MG INDIA

CAPECITABINE 500MG INDIA

GEMCITABINE 1G INDIA

GEMCITABINE 200MG INDIA

HEALTHCARE PHARMACEUTICALS LTD -RAJENDRAPUR GAZIPURHEBEI (JIHENG GRP) PHARMACEUTICALS CO.LTD-INDIAHEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368-HEBEI JIHENG (GROUP) PHARMACEUTICAL CO LTD 368 JIANSHE ST HENGSHUI CITY HEBEI 053000

HETERO DRUGS LTD, UNIT III -22-110, IDA, JEEDIMETLA

EFAVIRENZ+LAMIVUDINE+TENOFOVIR

600MG/300MG/300MG

HETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055, HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ,POLLEPALLY (VILLAGE), JADCHERLA (MANDAL)MAHABOOB NAGAR (DIST)-509301 INDIA.

EMTRICITABINE+TENOFOVIR DISOPROXIL FUMERATE

HETERO DRUGS LTD-UNIT-111 NO 22-110 I.D.A JEEDIMETTA HYDRABAD 500055,HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.

HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.

HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.

HETERO LABS (UNIT VI), INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V),JEDCHERLA(M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA.

Page 496: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PIOGLITAZONE HYDROCHLORIDE 45MG INDIA

PANTOPRAZOLE SODIUM 40 MG INDIA

PANTOPRAZOLE SODIUM 20MG INDIA

PIOGLITAZONE HYDROCHLORIDE 15MG INDIA

LINEZOLID 600MG INDIA

NEVIRAPINE 200MG INDIA

LAMIVUDINE 150MG INDIA

HETERO LABS LIMITED .-S.NO.10, I.D.A., GADDAPOTHARAM VILLAGE, JINNARAM MANDAL,MEDAK DISTRICT, ANDHRA PRADESH,INDIA

HETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458

POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR

(DISTRICT). PIN 509301

HETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458

POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR

(DISTRICT). PIN 509301

HETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458

POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR

(DISTRICT). PIN 509301

HETERO LABS LIMITED UNIT V-APIIC PHARMA SEZ, S. NO. 439, 440, 441 & 458 POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR (DISTRICT). PIN 509301

HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD,HETERO LABS LIMITED .-UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055

HETERO LABS LTD (UNIT-V)-SEZ JADCHERIA HYDRABAD,HETERO LABS LTD-HETERO LABS LTD, UNIT 111, H22-110, I.D.A, JEEDIMETLA, HYDERABAD, 500055

Page 497: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMLODIPINE BESILATE 10MG INDIA

FAMCICLOVIR 750MG INDIA

IRBESARTAN 150MG INDIA

IRBESARTAN 300MG INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

LOSARTAN POTASSIUM 100MG INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

Page 498: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LAMIVUDINE + ZIDOVUDINE 150MG + 300MG INDIA

300MG/300MG INDIA

VALACYCLOVIR 500MG INDIA

MOXIFLOXACIN HYDROCHLORIDE 400MG INDIA

BICALUTAMIDE 50MG INDIA

LETROZOLE 2.5MG INDIA

ZIDOVUDINE 300MG INDIA

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA,HETERO LABS LTD-UNIT II & III BADDI THE NALAGARH DIST SOLAN H.P

HETERO LABS LTD (UNIT-VI)-"SY.NO. 439, 440 & 458,APIIC FORMULATIONSEZ, POLEPALLY (V), JEDCHERLA (M)MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA

HETERO LABS LTD (UNIT-VI)-"SY.NO. 439, 440 & 458,APIIC FORMULATIONSEZ, POLEPALLY (V), JEDCHERLA (M)MAHABOOBNAGAR DISTRICT ANDHRA PRADESH-509301 INDIA

HETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,

Page 499: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ZIDOVUDINE 50MG/5ML INDIA

300 MG + 100 MG INDIA

FAMCICLOVIR 500MG INDIA

INDIA

ABACAVIR SULPHATE 20MG/ML INDIA

ANASTROZOLE 1MG INDIA

AMLODIPINE BESILATE 5MG INDIA

HETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH ,

ATAZANAVIR SULPHATE + RITONAVIR

HETERO LABS LTD UNIT III-22-110 IDA JEEDIMETIA HYDERABAD ANDHRA PRADESH, HETERO LABS LTD (UNIT-V)-SY.NO.438,439,440 & 458 APIIC FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGAR DISTRICT, ANDHRA PRADESH - INDIA

HETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA

EFAVIRENZ + EMTRICITABINE + TENOFOVIR

600MG + 200MG + 300MG

HETERO LABS LTD(UNIT V).-JADCHERLA (M),MAHABOOBNAGAR DIST, ANDHRA PRADESH,INDIA

HETERO LABS LTD, UNIT III-KALYANPUR, CHAKKAN ROAD, BADDI, DIST. SOLAN, HIMACHAL PRADESH, INDIA

HETERO LABS LTD, UNIT VI, INDIA-APIIC, FORMULATION SEZ, POLEPALLY (V), JEDCHERLA (M) MAHABOOBNAGER DISTRICT ANDHRA PRADESH-509301, INDIA

HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

Page 500: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SILDENAFIL CITRATE 50MG INDIA

LOPINAVIR / RITONAVIR 200MG /50MG INDIA

DONEPEZIL HYDROCHLORIDE 5MG INDIA

INDIA

ABACAVIR SULFATE + LAMIVUDINE 600MG + 300MG INDIA

DONEPEZIL HYDROCHLORIDE 10MG INDIA

LEVOFLOXACIN 250MG INDIA

HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

EFAVIRENZ+EMITRICITABINE+TENOFOVIR DISOPROXIL FUMARATE

600MG+200MG+300MG

HETERO LABS LTD. UNIT (V) .-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE), JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

Page 501: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SILDENAFIL CITRATE 100MG INDIA

VALSARTAN 160MG INDIA

MONTELUKAST SODIUM 10MG INDIA

PIOGLITAZONE HYDROCHLORIDE 30MG INDIA

VALSARTAN 80MG INDIA

DARUNAVIR 400MG INDIA

INDIA

LEVOCETIRIZINE DIHYDROCHLORIDE 5MG INDIA

RITONAVIR 100MG INDIA

TENOFOVIR DISOPROXIL FUMARATE 300MG INDIA

LOPINAVIR/ RITONAVIR 100MG/25MG INDIA

200MG + 300MG INDIA

GABAPENTIN 300MG PAKISTAN

HETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V)-439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA.

HETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA

HETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA

HETERO LABS LTD. UNIT (V)-S.N0.439, 440, 441& 458, APIIC, PHARMA SEZ, POLLEPALLY (VILLAGE),JADCHERLA (MANDAL) MAHABOOB NAGAR (DIST)-509301 INDIA

HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

150MG +300MG + 200MG

HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESHHETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE

HETERO LABS LTD-22-110 IDA JEEDIMETLA HYDERABAD 500-055 ANDHRA PRADESH

HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI

Page 502: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GABAPENTIN 400MG PAKISTAN

100MG PAKISTAN

100MG/0.35MG PAKISTAN

DICLOFENAC 50MG PAKISTAN

CEFACLOR 250MG PAKISTAN

CEFACLOR 500MG PAKISTAN

CEFIXIME 400MG PAKISTAN

CEFIXIME 100MG/5ML PAKISTAN

TRANEXAMIC ACID 500MG/5ML PAKISTAN

GABAPENTIN 100MG PAKISTAN

MONTELUKAST SODIUM 10MG PAKISTAN

TRANEXAMIC ACID 500MG PAKISTAN

50MG/5ML PAKISTAN

TRANEXAMIC ACID 250MG/5ML PAKISTAN

CEPHADRINE 250MG PAKISTAN

TRANEXAMIC ACID 250MG PAKISTAN

MONTELUKAST SODIUM 5MG INDIA

MOXIFLOXACIN HYDROCHLORIDE 400MG GERMANY

ACETYLSALICYLIC ACID 100MG GERMANY

5 MG+50 MG / ML GERMANY

MOXIFLOXACIN HCL 400MG/250ML GERMANY

DICLOFENAC SODIUM 100MG MALAYSIA

HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI

IRON(III) HYDROXIDE POLYMALTOSE COMPLEX

HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI

IRON(III)HYDROXIDE POLYMALTOSE COMPLEX/FOLIC ACID

HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI

HILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHIHILTON PHARMA (PVT) LTD-PLOT 13 SECTOR 15 KORANGI INDUSTRIAL AREA KARACHI

IRON (III) HYDROXIDE POLYMALTOSE COMPLEX

HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.

HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.

HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.

HILTON PHARMA (PVT) LTD-PLOT 13, SECTOR 15, KORANGI INDUSTRIAL AREA,KARACHI, PAKISTAN.

HILTON PHARMA PVT,LTD-13 SECTOR 15,KORANG,IND.AREA,8TH FLOOR PROGRESSIVE PLAZA,BEAMONT RD,KARACHI

HOSPIRA INC-D - 51368 LEVERKUSENGERMANYHOSPIRA INC-D - 51368 LEVERKUSENGERMANY

ESTRADIOL VALERATE +NORETHINDRONE ENANTHATE

HOSPIRA INC-D - 51368 LEVERKUSENGERMANYHOSPIRA INC-D - 51368 LEVERKUSENGERMANYHOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA

Page 503: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

250MG + 200MG INDIA

DICLOFENAC SODIUM 50MG MALAYSIA

METFORMIN HYDROCHLORIDE 1000MG MALAYSIA

METFORMIN HYDROCHLORIDE 500MG MALAYSIA

5MG,500MG MALAYSIA

KETOPROFEN 2.5%W/W MALAYSIA

MONTELUKAST 10MG MALAYSIA

MALAYSIA

METFORMIN HYDROCHLORIDE 850MG MALAYSIA

AMLODIPINE BESILATE 10MG MALAYSIA

ATORVASTATIN 10MG MALAYSIA

KETOCONAZOLE 2%W/W MALAYSIA

AMLODIPINE BESILATE 5MG MALAYSIA

AMOXYCILLIN 500MG MALAYSIA

FLUCONAZOLE 150MG MALAYSIA

KETOCONAZOLE 2%W/W MALAYSIA

ACICLOVIR 400MG MALAYSIA

ACICLOVIR 5%W/W MALAYSIA

ALENDRONATE SODIUM 70MG MALAYSIA

ITRACONAZOLE 100MG MALAYSIA

TRAMADOL HYDROCHLORIDE SR 100MG MALAYSIA

GLUCOSAMINE SULPHATE + CHONDROITIN SULPHATE

HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA

HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA

HOVID BERHAD (CHEMOR SITE)--LOT 56442, 71/2, JALAN IPOH/CHEMOR 31200, PERAK. MALAYSIA

HOVID BERHAD-121, JALAN TUNKU ABDUL RAHMAN, 30010 IPOH, PERAK, MALAYSIA

GLIBENCLAMIDE + METFORMIN HYDROCHLORIDE

HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA

HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA

HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA

THIAMINE MONONITRATE/ PYRIDOXINE/ CYANOCOBALAMIN

245.5MG/ 250MG/ 1.4MG

HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA

HOVID BHD (IPOH SITE)-121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA

HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIA

HOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD -121 ,JALAN TUNKU ABDUL RAHMAN , 30010 IPOH , PERAK , MALAYSIAHOVID BHD-LOT 56442 7 1/2 MILES JALAN IPOH / CHEMOR 31200 CHEMORHOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

Page 504: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

KETOCONAZOLE 200MG MALAYSIA

500MG MALAYSIA

IBUPROFEN BP 400 MG MALAYSIA

AZITHROMYCIN DIHYDRATE 250MG MALAYSIA

GRISEOFULVIN 500MG MALAYSIA

MALAYSIA

CARBAMAZEPINE 200MG MALAYSIA

METFORMIN HYDROCHLORIDE 850MG MALAYSIA

RABIES VACCINE 2.5 I.U/VAIL INDIA

HEPATITIS B (RDNA) 20MCG/ML INDIA

DEXKETOPROFEN TROMETAMOL 25MG TURKEY

DESLORATADINE 5MG TURKEY

MOXIFLOXACIN HYDROCHLORIDE 400MG TURKEY

DESLORATIDINE 2.5 MG / 5 ML TURKEY

300MG + 12.5MG INDIA

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

METFORMIN HCL EXTENDED RELEASE

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

THIAMINE MONONITRATE + PYRIDOXINE HCL + CYANOCOBALAMINE

97MG + 50MG + 100MG

HOVID BHD-LOT 56442, 7.5 MILE JALAN IPOH/CHEMO 31200 CHEMOR, PERAK MALAYSIA

HOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAHOVID BHD-LOT 56442,71/2 MILES JALAN IPOH,PERAK,MALAYSIAHUMAN BIOLOGICALS INSTITUTE ( A DIVISION OF INDIAN IMMUNOLOGICALS LTD) .-KOZHIPANNAI PUDUMUND P.O DR. BASAVAIAH NAGAR UDHAGAMANDALAM PIN: 643007 TAMIL NADU

HUMAN BIOLOGICALS INSTITUTE (A DIVISION OF INDIAN IMMUNOLOGICALS LTD)- RAKSHAPURAM GACHIBOWLI POST HYDERABAD 500032

İLKO İLAÇ SANAYI VE TICARET A. Ş-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1SELÇUKLU / KONYA

İLKO İLAÇ SANAYI VE TICARET A. Ş-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1SELÇUKLU / KONYA

İLKO İLAÇ SANAYI VE TICARET A. Ş-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1SELÇUKLU / KONYA

İLKO İLAÇ SANAYI VE TICARET A. Ş-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1SELÇUKLU / KONYA

IRBESARTAN + HYDROCHLOROTHIAZIDE

İLKO İLAÇ SANAYI VE TICARET A. Ş-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1SELÇUKLU / KONYA

Page 505: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

150MG + 12.5MG TURKEY

CLOPIDOGREL 75MG INDIA

ATORVASTATIN 100MG INDIA

AZITHROMYCIN 500MG INDIA

AZITHROMYCIN 250MG INDIA

40MG + 12.5MG INDIA

80MG + 12.5MG INDIA

500MG+125MG INDIA

CLOTRIMAZOLE 1%W/W INDIA

INDIA

CLOTRIMAZOLE/ BECLOMETASONE INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

10MG+10MG INDIA

INDIA

CETIRIZINE 10MG INDIA

CHLORHEXIDINE GLUCONATE 0.2%W/V INDIA

AZITHROMYCIN DIHYDRATE 200MG/5ML INDIA

ALBENDAZOLE 200MG/5ML INDIA

CIPROFLOXACIN 500MG INDIA

INDIA

IRBESARTAN + HYDROCHLOROTHIAZIDE

İLKO İLAÇ SANAYI VE TICARET A. Ş-3. ORGANIZE SANAYI BÖLGESI KUDDUSI CAD. 23. SOK. NO:1SELÇUKLU / KONYA

IND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALIIND SWIFT LTD-GBU JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALIIND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507

IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507

TELMISARTAN + HYDROCHLOROTHIAZIDE

IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507

TELMISARTAN + HYDROCHLOROTHIAZIDE

IND SWIFT LTD-GLOBAL BUSINESS UNIT JAWAHARPUR OFF NH-21 DERABASSI DIST MOHALI PUNJAB 140507

AMOXICILLIN+CLAVULANATE POTASSIUM

INDCHEMIE HEALTH SPECIALITIES PVT LTD-VILLAGE THANA TEHSIL BADDI DIST SOLAN HIMACHAL PRADESH 173 205

INDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA

CLOTRIMAZOLE/BECLOMETHASONE/GENTAMYCIN

1%W/W+0.025%W/W+0.1%W/W

INDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNA

1%W/W/ 0.025%W/W

INDOCO REMEDIES LIMITED-L-14 VERNA INDUSTRIAL AREA VERNAINDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722

DOXYLAMINE SUCCINATE + PYRIDOXINE HYDROCHLORIDE

INDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722

METHYL NICOTINATE+MEPHENESIN+METHYL SALICYLATE+MENTHOL

1%W/W+5%W/W+8%W/W+2%W/W

INDOCO REMEDIES LTD - 0-.L-14 VERNA INDUSTRIAL AREA, VERNA, GOA-403722

INDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIA

INDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD, B-20,-B-20 MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA

ALUMINIUM HYDROXIDE + SIMETHICONE + MAGNESIUM

400MG/5ML + 25MG/5ML + 100MG/5ML

INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA

Page 506: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DISODIUM HYDROGEN CITRATE 1.37G/5ML INDIA

MULTI-INGREDIENT N/A INDIA

ALBENDAZOLE 400MG INDIA

CALCIUM CARBONATE/VITAMIN D 250MG+125IU/5ML INDIA

METFORMIN 500MG INDIA

ERYTHROMYCIN STEARATE 250MG INDIA

PARACETAMOL 500MG INDIA

INDIA

IBUPROFEN 200MG INDIA

IBUPROFEN+PARACETAMOL 400MG+500MG INDIA

METFORMIN 850MG INDIA

DICLOFENAC SODIUM 50MG INDIA

NITAZOXANIDE 500MG INDIA

NITAZOXANIDE 200MG INDIA

NITAZOXANIDE 100MG/5ML INDIA

ESOMEPRAZOLE MAGNESIUM 40MG INDIA

ESOMEPRAZOLE MAGNESIUM 20MG INDIA

METFORMIN 500MG INDIA

CETIRIZINE HCL 10MG INDIA

500MG INDIA

CLARITHROMYCIN 250MG INDIA

INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA

INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA

BROMHEXINE HYDROCLORIDE + TERBUTALINE SULPHATE + AMMONIUM CHLORIDE + MENTHOL

8 MG + 2.5 MG + 100 MG + 1.5 MG

INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIA

INDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCO REMEDIES LTD-B-20, MIDC, WALUJ, AURANGABAB 431136 INDIAINDOCOS REMEDIES LTD-L-14 VERNA INDUSTRIAL AREA VENA GOA-403722

IND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA

IND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA

IND-SWIFT LIMITED-INDUSTRIAL GROWTH CENTRE, PHASE I, SAMBA (JAMMU), J&K 184121, INDIA

IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI

CLARITHROMYCIN(EXTENTED RELEASE)

IND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSIIND-SWIFT-LTD,-GLOBAL BUSINESS UNIT, JAWAHARPUR, OFF NH-21 DERABASSI

Page 507: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ATORVASTATIN 200MG INDIA

CEFIXIME 100MG/5ML INDIA

CEFTRIAXONE 1G INDIA

CEFTRIAXONE SODIUM 1G INDIA

ROSUVASTATIN 5MG INDIA

ROSUVASTATIN 20MG INDIA

TORSEMIDE 10MG INDIA

ORLISTAT 120MG INDIA

PREGABALIN +MECOBALAMIN 75MG+750MCG INDIA

AMLODIPINE 5MG INDIA

ATORVASTATIN 20MG INDIA

ROSUVASTATIN 10MG INDIA

ENALAPRIL MALEATE 5MG INDIA

FEBUXOSTAT 40MG INDIA

DIVALPROEX 500MG INDIA

ACECLOFENAC SR 200MG INDIA

INDUS PHARMA (PVT) LTD ,-PLOTS NO. 64, 65, 66 & 67, SECTOR -27, KORANGI INDUSTRIAL AREA, KARACHI - 74900

INDUS PHARMA (PVT) LTD ,-PLOTS NO. 64, 65, 66 & 67, SECTOR -27, KORANGI INDUSTRIAL AREA, KARACHI - 74900

INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARATINTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA

INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA

INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA

INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA

INTAS PHARMACEUTICALS LIMITED -CAMP ROAD, SELAQUI-248197,DEHRADUN UTTARAKHAND, INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

Page 508: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NIFEDIPINE 20MG INDIA

RISPERIDONE 2MG INDIA

RAMIPRIL 5MG INDIA

CARVEDILOL 6.25MG INDIA

TORSEMIDE 5MG INDIA

50MG + 12.5MG INDIA

RABEPRAZOLE SODIUM 20 MG INDIA

DROTAVERINE HYDROCHLORIDE 40MG INDIA

QUININE DIHYDROCHLORIDE 300MG/ML INDIA

INDIA

SILDENAFIL CIRATE 100MG INDIA

FINASTERIDE 5MG INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA,INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT

INTAS PHARMACEUTICALS LIMITED-PLOT NO. 457 / 458SARKHEJ-BAVLA HIGHWAY, MATODA - 382 210, TALUKA - SANAND,DISTRICT - AHMEDABAD, STATE -

INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT

TINIDAZOLE/CLARITHROMYCIN/LANSOPRAZOLE

500MG+ 250MG+30MG

INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT

INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT

INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT

Page 509: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SILDENAFIL CITRATE 50MG INDIA

TORSEMIDE 20MG INDIA

LANSOPRAZOLE 30MG INDIA

PREGABALIN 75MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

ACECLOFENAC 100MG INDIA

AMLODIPINE 10MG INDIA

SECNIDAZOLE 1GM INDIA

ENALAPRIL MALEATE 10MG INDIA

CARVEDILOL 12.5MG INDIA

ACECLOFENAC + PARACETAMOL 100 MG + 500 MG INDIA

PIPERACILLIN+TAZOBACTAM 5MG+500MG INDIA

METFORMIN HYDROCHLORIDE 500MG INDIA

METFORMIN HYDROCHLORIDE 1000MG INDIA

INTAS PHARMACEUTICALS LTD .-PLOT NOS. 457, 458 & 191/218P SARKHEJ-BAVLA HIGHWAY MATODA SANAND AHMEDABAD GUJARAT

INTAS PHARMACEUTICALS LTD -CAMP ROAD, SELAQUI – 248 197 DEHRADUN (UK)

INTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINTAS PHARMACEUTICALS LTD-CAMP ROAD SELAQUI DEHRADUNINTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA

INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA

INTAS PHARMACEUTICALS LTD-PLOT 457/458, SARKHEJ BAVLA HIGHWAY MATODA 382 210 TAL: SANAND, AHMEDABAD, INDIA,INTAS PHARMACEUTICALS LIMITED(BIOPHARMA DIVISION)-CAMP ROAD SELAQUI-248197, DEHRADUN (UTTARAKHAND) INDIA

INTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INTAS PHARMACEUTICALS LTD-SELAQUI DEHRADUN 248197INTRACIN PHARMACEUTICAL PVT LTD-C-1, B -53, G.I.D.C ESTATE, NADIAD – 387001 GUJARAT, INDIA.,

INVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE,MAHARASHTRA, INDIA.

INVENTIA HEALTHCARE PRIVATE LIMITED-F1-F1/1, ADDITIONAL AMBERNATH MIDC, AMBERNATH (EAST), DISTRICT THANE, 421 0506, DIST. THANE,MAHARASHTRA, INDIA.

Page 510: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

RABEPRAZOLE 20MG INDIA

OMEPRAZOLE + DOMPERIDONE 20MG + 30MG INDIA

AMOXYCILLIN+CLAVULANIC ACID 500MG+125MG INDIA

AMOXYCILLIN + CLAVULANIC ACID 250 MG + 125 MG INDIA

250MG + 62.5MG INDIA

ARTEMETHER 80MG/ML INDIA

ARTESUNATE 60MG INDIA

ARTEMETHER / LUMEFANTRINE 80MG/480MG INDIA

INDIA

AZITHROMYCIN 500MG INDIA

ACECLOFENAC 100MG INDIA

INVENTIA HEALTHCARE PVT. LTD .-FI – FI /1 ADDITIONAL AMBERNATH(EAST) – 421 506,MAHARASHTRA DIST. THANE, INDIA

INVENTIA HEALTHCARE PVT. LTD-FI – FI /1 ADDITIONAL AMBERNATH,M.I.D.C. AMBERNATH (EAST) – 421 506, DIST. THANE, INDIA

IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT

IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT

AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE

IPCA LABORATORIES LTD,.-PLOT 69 TO 72 (B), SECTOR II, KASEZ, GANDHIDHAM - 370230, GUJARAT

IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067

IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067

IPCA LABORATORIES LTD,-SEJAVTA,RATLAM 457-002 REG.OFF.48 KANDIVLI IND.ESTATE MUMBAI 400067

DIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM HYDROCHLORIDE+SODIUM CITRATE+MENTHOL

14MG+135MG+57MG+1.1MG

IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA

IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA

IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA

Page 511: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AZITHROMYCIN 250MG INDIA

CHLORTHALIDONE 50MG INDIA

CHLORTHALIDONE 25MG INDIA

ETODOLAC 400MG INDIA

ROSUVASTATIN CALCIUM 5MG PUERTO RICO

ROSUVASTATIN 10MG PUERTO RICO

ROSUVASTATIN CALCIUM 20MG PUERTO RICO

KENYA

SODIUM CHLORIDE + GLUCOSE 0.9%W/V + 5%W/V KENYA

PREDNISOLONE ACETATE 1%W/V INDIA

TIMOLOL MALEATE 0.5%W/V KENYA

IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA

IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA

IPCA LABORATORIES LTD-SEJAVTA, RATLAM-457 002 (M.P.) INDIA

IPCA LABORATORIESLIMITED-IPCA LABORATORIES LTD P.O SEJANTA DISTRICT RATLAM 457002 INDIA

IPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO

IPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO

IPR PHARMACEUTICALS INC,-LOT 17 INDUSTRIAL PARK PUERTO RICO, SAN ISIDRO, PUERTO RICO

SODIUM LACTATE+SODIUM CHLORIDE+POTASSIUM CHLORIDE+ CALCIUM CHLORIDE DIHYDRATE

0.32G+0.6G+0.04+0.027/100ML

IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184

IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI

IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI

IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI

Page 512: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BETAXOLOL HYDROCHLORIDE 0.5%W/V KENYA

CIPROFLOXACIN HYDROCHLORIDE 0.3%W/V KENYA

BETAMETHASONE 1MG/ML KENYA

SODIUM CROMOGLYCATE 2%W/V KENYA

TIMOLOL MALEATE 0.25%W/V KENYA

HYDROCORTISONE ACETATE 1%W/V KENYA

STERILIZED WATER FOR INJECTION N/A KENYA

DEXAMETHASONE/GENTAMICIN 0.1% & 0.3%W/V KENYA

DEXAMETHASONE/NEOMYCIN 0.1% & 0.35%W/V KENYA

DEXAMETHASONE 0.1%W/V KENYA

EPHEDRINE HYDROCHLORIDE 0.5%W/V KENYA

IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI

IVEE INFUSION EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE LR NO. 18474184 NAIROBI

IVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,LR NO.18474/84,ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,LR NO.18474/84,ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD-ATHI RIVER EXPORT PROCESSING ZONE,LR NO.18474/84,ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

Page 513: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EPHEDRINE HYDROCHLORIDE 1%W/V KENYA

GENTAMICIN SULPHATE 0.3%W/V KENYA

FLURBIPROFEN SODIUM 0.03%W/V KENYA

0.05%W/V KENYA

CHLORAMPHENICOL 0.5%W/V KENYA

0.1% & 1%W/V KENYA

BETAMETHASONE + ENOMYCIN KENYA

CHLORAMPHENICOL 5%W/V KENYA

XYLOMETAZOLINE HYDROCHLORIDE 1MG/ML KENYA

MEBENDAZOLE 100MG/5ML INDIA

PEFLOXACIN 400MG INDIA

AZITHROMYCIN 500MG INDIA

METRONIDAZOLE 200MG INDIA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

TETRAHYDROZOLINE HYDROCHLORIDE

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

DEXAMETHASONE/CHLORAMPHENICOL

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

0.1 %W/V + 0.35 %W/V

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

IVEE INFUSIONS EPZ LTD--LR NO.18474/84,ATHI RIVER BOX 25251 00100 NAIROBI KENYA ATHI RIVER,KENYA

J.B CHEMICALS & PHARMACEUTICALS LTD-128/1 GIDC ANKLESHWAR 393 022 GUJARAT INDIA

J.B CHEMICALS-ANKLESHWAR, GUJARAT 393002 INDIA

J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, G.I.D.C. INDUSTRIAL AREA, ANKLESHWAR, GUJARAT 393002 INDIA

J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT

Page 514: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PANTOPRAZOLE 40MG INDIA

MULTIINGREDIENT N/A INDIA

LEVONORGESTREL 1.5MG INDIA

RILPIVIRINE 25MG JANSSEN CILAG S.P.A-VIA C.JANSSEN, BORGO ITALY

DARUNAVIR 600MG

DARUNAVIR 400MG

DARUNAVIR 150MG

DARUNAVIR 75MG

HALOPERIDOL 5MG/ML BELGIUM

HALOPERIDOL DECANOATE 50MG/ML BELGIUM

MICONAZOLE NITRATE 400MG

ETRAVIRINE 25MG ITALY

ETRAVIRINE 100MG ITALY

DOMPERIDONE 10MG JANSSEN-CILAG-27 100 VAL DE REUIL, FRANCE FRANCE

CIPROFLOXACIN 250MG INDIA

QUININE DIHYDROCHLORIDE 300MG/ML GERMANY

TETRACYCLINE 250MG CHINA

J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT

J.B. CHEMICALS AND PHARMACEUTICALS LTD-J.B. CHEMICALS & PHARMACEUTICALS LTD, 215/216, GIDC, PANOLI, GUJARAT

JAGSONPAL PHARMACEUTICALS LTD-PLOT NO.14-16,55-57,SECTOR-5,IIE PANT NAGAR,SIDCUL,RUDRAPUR UDHAM SINGH NAGAR,UTTARAKHAND-263153 INDIA

JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778

UNITED STATES

JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778

UNITED STATES

JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778

UNITED STATES

JANSSEN ORTHO LLC.--STATE ROAD 933 KM 0.1 MARNEY WARD GURABO PUERTO RICO 00778

UNITED STATES

JANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30B-2340 BEERSEBELGIUM

JANSSEN PHARMACEUTICAL NV-TURNHOUTSEWEG 30B-2340 BEERSEBELGIUM

JANSSEN PHARMACEUTICAL PTY LTD-15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

JANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINAJANSSEN-CILAG S.P.A.-VIA C. JANSSEN BORGO S. MICHELE 04100 LATINA

JB CHEMICALS AND PHARMACEUTICALS-128/1,CIIDC ANKLESHWER 393 002GUAZARAT INDIA

JIANGSU PENGYAO PHARMACEUTICAL CO LTD .-NO. 10 CHAQUAN ROAD YICHENG TOWN YIXING CITY JIANGSU PROVINCE

JIANGSU PENGYAO PHARMACEUTICAL CO LTD .-NO. 10 CHAQUAN ROAD YICHENG TOWN YIXING CITY JIANGSU PROVINCE

Page 515: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIMETIDINE 400MG CHINA

TETRACYCLINE 250MG CHINA

METRONIDAZOLE 200MG CHINA

CIMETIDINE 200MG CHINA

CHLORAMPHENICOL 250MG CHINA

GENTAMYCIN SULPHATE 80MG/2ML CHINA

DICLOFENAC 75MG/3ML CHINA

QUININE DIHYDROCHLORIDE 600MG/2ML CHINA

QUININE DIHYDROCHLORIDE 600MG/2ML CHINA

ARTEMETHER 80MG/ML CHINA

40MG + 320MG CHINA

IBUPROFEN 400 MG INDIA

QUININE DIHYDROCHLORIDE 600MG/2ML CHINA

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD -NO. 10 CHAQUAN ROAD YIXING CITY JIANGSU PROVINCE,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR,ANHUI CHENGSHI PHARMACEUTICAL CO. LTD,-NO.5068 HUAISHANG ROAD,HEBEI NEW AREA INDUSTRIAL PARK, BENGBU,ANHUI,CHINA.

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA

DIHYDROARTEMISININ+PIPERAQUINE PHOSPHATE

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA,GRAND PHARMACEUTICAL (CHINA) CO. LTD--LAKE ROAD NELL JINYINHU ECOLOGICAL PARKDONG XI HU DISTRICT, WUHAN, HEBEI PROVINCE.

Page 516: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DICLOFENAC SODIUM 75MG/ML CHINA

DOXYCYCLINE 100MG CHINA

ALCOHOL + THYMOL 95 % W/V + 12 MG

THYMOL + ALCOHOL 95%

7MG/5ML

15MG/ML

MENTHOL + ALCOHOL 95% 0.02% + 4.58ML

ORCIPRENALINE+BROMOHEXENE

30MG + 200MG

PYRANTEL PAMOATE 125MG

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

JIANGSU PENGYAO PHARMACEUTICALS CO. LTD-NO. 10 CHAQUAN ROAD,YIXING CITY, CHINA,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

JOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794

SOUTH AFRICA

ZINC CHLORIDE + DENATURED ALCOHOL MENTHOL 95% + THYMOL

18MG/ 20ML + 0.9ML/20ML + 12.7MG/20ML

JOHNSON&JOHNSON PTY LTD..-241 MAIN ROAD RETREAT 794

SOUTH AFRICA

12.78MG/20ML + 5.60ML/ML

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

DIPHENHYDRAMINE HYDROCHLORIDE

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

DEXTROMETHORPHAN HYDROBROMIDE

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

DIPHENHYDRAMINE HYDROCHLORIDE + AMMONIUM CHLORIDE

12.5 MG/5ML + 125 MG/5ML

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + CODEINE PHOSPHATE

12.5MG/5ML +125MG/5ML +10MG/5ML

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

DIPHENHYDRAMINE + PARACETAMOL + PSEUDOEPHEDRINE

25MG/20ML + 1G/20ML + 45MG/20ML

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

5MG/5ML+ 4MG/5ML

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

PARACETAMOL/ CHLORPHENIRAMINE/ EPHEDRINE

500MG/ 2MG/ 30MG

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

PSEUDOEPHEDRINE HCL + IBUPROFEN

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

Page 517: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

200MG + 30MG

ERYTHROPOIETIN 4000I.U

VANCOMYCIN 0.5G/VIAL

AMOXYCILLIN 125MG/5ML UGANDA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG UGANDA

CO-TRIMOXAZOLE 240MG/5ML UGANDA

PARACETAMOL 250MG UGANDA

PHENOBARBITONE 30MG UGANDA

PYRIDOXINE HYDROCHLORIDE 25MG UGANDA

AMPICILLIN 125MG/ML UGANDA

PARACETAMOL 120MG/5ML UGANDA

AMPICILLIN 250MG UGANDA

IBUPROFEN + PSEUDOEPHEDRINE HCL

JOHNSON&JOHNSON PTY LTD.-EDMS BPK241 MAIN ROAD /HOOFWEG 241,RETREAT 7945,SOUTH AFRICA

SOUTH AFRICA

JULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAE

UNITED ARAB EMIRATES

JULPHAR GULF PHARMACEUTICAL INDUSTRIES-DIGDIGA AREA, AIR PORT ROAD P.O BOX 977 RAS-AL KHAIMAH UAE

UNITED ARAB EMIRATES

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

Page 518: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ERYTHROMYCIN ESTOLATE 250MG UGANDA

METFORMIN HYDROCHLORIDE 500MG UGANDA

CHLOROQUINE PHOSPHATE 250MG UGANDA

PARACETAMOL 500MG UGANDA

PREDNISOLONE 5MG UGANDA

QUININE SULPHATE 300MG UGANDA

SULPHADOXINE + PYRIMETHAMINE 500MG + 25MG UGANDA

ERYTHROMYCIN ESTOLATE 125MG/5ML UGANDA

PHENOXYMETHYLPENICILLIN 125MG/5ML UGANDA

PHENOXYMETHYLPENICILLIN 250MG UGANDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

Page 519: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

QUININE 100MG/5ML UGANDA

PARACETAMOL 250MG UGANDA

CO-TRIMOXAZOLE 480MG UGANDA

BETAMETHASONE VALERATE 0.1%W/W UGANDA

AMPICILLIN + CLOXACILLIN UGANDA

ASCORBIC ACID 100MG UGANDA

CEFTRIAXONE 1G UGANDA

AMOXYCILLIN 250MG UGANDA

DOXYCYCLINE HYDROCHLORIDE 100MG UGANDA

DICLOFENAC SODIUM 50MG UGANDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

250 MG / 5 ML + 250 MG / 5 ML

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LIMITED - -STRETCHER ROAD PLOT M444B NTINDA KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA

Page 520: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIPROFLOXACIN 500MG UGANDA

AMOXICILLIN TRIHYDRATE 125MG UGANDA

DICLOFENAC SODIUM 100MG UGANDA

CETIRIZINE HYDROCHLORIDE 10MG UGANDA

CLOXACILLIN 125MG/5ML UGANDA

CHLOROQUINE PHOSPHATE 80MG/5ML UGANDA

CLOXACILLIN 250MG UGANDA

500 MG + 10.5 MG UGANDA

SALBUTAMOL 4MG UGANDA

CHLOROQUINE PHOSPHATE 250MG UGANDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD -PLOT NO. M444B, STRETCHER ROAD, NTINDA, KAMPALA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA

KAMPALA PHARMACEUTICAL INDUSTRIES (1996) LTD-PLOT M 444B STRETCHER ROAD NTINDA

ACETAMINOPHEN + PHENIRAMINE MALEATE

KAMPALA PHARMACEUTICALS INDUSTIES-PLOT M 444B STRETCHER NTINDA

KAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDA

KAMPALA PHARMACEUTICALS INDUSTIES-PLOT NO M44B STRETCHER ROAD INTINDA

Page 521: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CHLORAMPHENICOL 250MG UGANDA

HYDROCORTISONE 1%W/W UGANDA

MULTINGREDIENT MULTINGREDIENT UGANDA

ACETYL SALICYLIC ACID 300MG UGANDA

UGANDA

UGANDA

MULTI-INGREDIENT MULTI-INGREDIENT UGANDA

MEBENDAZOLE 100MG UGANDA

METRONIDAZOLE 200MG UGANDA

METRONIDAZOLE BENZOATE 200MG/5ML UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

PARACETAMOL+PSEUDOEPHEDRINE HYDROCHLORIDE+TRIPOLIDINE HYDROCHLORIDE

300MG+36MG+1.5MG

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

CHLORPHENAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE+PARACETAMOL

1.25MG+10MG+120MG

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

Page 522: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SULFADOXINE/PYRIMETHAMINE 525MG UGANDA

HYDROCORTISONE 1%W/W UGANDA

LOPERAMIDE HYDROCHLORIDE 2MG UGANDA

MULTI-INGREDIENT MULTI-INGREDIENT UGANDA

UGANDA

NYSTATIN 500,000IU UGANDA

AMLODIPINE 5MG UGANDA

OMEPRAZOLE 20MG UGANDA

BETAMETHASONE VALERATE 0.1%W/W UGANDA

AMPICILLIN SODIUM 500MG INDIA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

ACETAMINOPHEN+ASPIRIN+CAFFEINE

200MG+ 400MG+50MG

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD.-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KAMPALA PHARMECEUTICALS INDUSTRIES LTD-PLOT M444B STRETCHER RD, NTINDA KLA UGANDA

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058

Page 523: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1G INDIA

CLOXACILLIN SODIUM 500MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

100MG INDIA

CHINA

500MG +125MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

ATENOLOL 100MG INDIA

LEVOFLOXACIN 500MG INDIA

RABEPRAZOLE SODIUM 20MG INDIA

CHLORAMPHENICOL SODIUM SUCCINATE

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058

HYDROCORTISONE SODIUM SUCCINATE

KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD- #14, II PHASE PIA, BANGALORE 560058

VIT B1+ VIT B2 +VIT B3 + NICOTINAMIDE+PANTOTHENOL

10MG +1MG +1MG +16MG +0.5MG

KIVI PHARM CO. LTD .-NO.5 HANGTIAN STREET,DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE,SHALINGZI TOWN, XUANHUA,ZHANGJIAKOU CITY,HEBEI 075100, CHINA*

AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

Page 524: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIPROFLOXACIN 500MG INDIA

AMOXYCILLIN 250MG INDIA

AMPICILLIN 250MG INDIA

CO-TRIMOXAZOLE 480MG INDIA

160MG/800MG INDIA

CLOXACILLIIN 250MG INDIA

FLUCLOXACILLIN SODIUM 250MG INDIA

OMEPRAZOLE 20MG INDIA

250MG INDIA

CEPHALEXIN MONOHYDRATE 250MG MALAYSIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

KOPRAN LIMITED-VILLAGE- SAVROLI (KHOPOLI), TALUKA- KHALAPUR, DIST. RAIGAD, MAHARASHTRA, INDIA

TRIMETHOPRIM/SULFAMETHOXAZOLE

KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202

KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202

KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202

KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202

ERYTHROMYCIN STEARATE TABLETS BP

KOPRAN LTD-VILLAGE SAVROLI TAL KHARAPUR DIST RAIGAD 410 202

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

Page 525: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CETIRIZINE DIHYDROCHLORIDE 5MG/5ML MALAYSIA

HYDROCORTISONE 1%W/W MALAYSIA

LIDOCAINE 2%W/W MALAYSIA

LIGHT KAOLIN + PECTIN (CITRUS) 1G + 20MG/5ML MALAYSIA

MICONAZOLE NITRATE 2%W/W MALAYSIA

PARACETAMOL 250MG/5ML MALAYSIA

PHOLCODINE 10MG/5ML MALAYSIA

CEPHALEXIN MONOHYDRATE 125MG/5ML MALAYSIA

MALAYSIA

MALAYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

MAGNESSIUM HYDROXIDE +ALUMINIUM HYDROXIDE+SIMETHICONE

400MG/5ML+400MG/5ML+40MG/5ML

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

FUSIDIC ACID+BETAMETHASONE 17 VALERATE

2%,W/W,+0.1% W/W

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

Page 526: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFUROXIME 750MG MALAYSIA

500MG+4MG+60MG MALAYSIA

CEFUROXIME AXETIL 250MG MALAYSIA

BETAMETHASONE 0.1%W/W MALAYSIA

CEPHALEXIN MONOHYDRATE 500MG MALAYSIA

LORATADINE 10MG MALAYSIA

15MG/5ML MALAYSIA

METRONIDAZOLE 200MG MALAYSIA

MALAYSIA

FUSIDIC ACID 2%W/W MALAYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

PARACETAMOL+CHLORPHENIRAMINE+PSEUDOEPHEDRINE

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

DEXTROMETHORPHAN HYDROBROMIDE

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

DIPHENAHYDRAMINE HCL+AMMONIUM CHLORIDE

12.5MG+130MG/5ML

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

Page 527: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IBUPROFEN 100MG/5ML MALAYSIA

CEFTAZIDIME 1G MALAYSIA

500MG + 500MG MALAYSIA

CEFTRIAXONE 500MG MALAYSIA

CEFTRIAXONE 1G MALAYSIA

2% W/W + 1% W/W MALAYSIA

METRONIDAZOLE 400MG MALAYSIA

7MG+67.5MG/5ML MALAYSIA

IBUPROFEN 200MG UGANDA

CLOTRIMAZOLE 1%W/W UGANDA

KOTRA PHARMA (M) SDN. BHD-1 JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA MALYSIA

KOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKA

CEFOPERAZONE SODIUM+SULBACTAM SODIUM

KOTRA PHARMA (M) SDN.BHD,-1,2 & 3 JALAN TTC 12 CHENG INDUSTRIAL ESTATE 75250 MELAKA

KOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

KOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

MICONAZOLE NITRATE + HYDROCORTISONE

KOTRA PHARMA SDN BDN-1, 2, &3, JALANTTC12 CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

KOTRA PHARMA-BHD1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA

DIPHENHYDRAMINE HCL/ AMMONIUM CHLORIDE

KOTRA PHARMA-BHD1, JALAN TTC 12, CHENG INDUSTRIAL ESTATE, 75250 MELAKA, MALAYSIA

KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA

KPI ( KAMPALA PHARMACEUTICAL INDUSTIRES LTD-PLOT M444 B STRETCHER ROAD NTINDA

Page 528: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMLODIPINE BESILATE 10MG UGANDA

BETAMETHASONE+NEOMYCIN 1MG/G+5MG/G UGANDA

UGANDA

BENZOIC ACID + SALICYLIC ACID 6% W/W + 3% W/W INDIA

INDIA

CLOTRIMAZOLE 1%W/W INDIA

INDIA

METHYL SALICYLATE BP 15000MG INDIA

SULPHUR 10%W/W INDIA

NEOMYCIN SULPHATE CREAM USP 0.5%WW INDIA

KPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA

KPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA

MICONAZOLE NITRATE BP + CLOBETASOL PROPIONATE BP + GENTAMYCIN SULPHATE

2.0%W/W + 0.05%W/W + 0.1 %W/W

KPI INDUSTRIES (1996) LTD-PLOT NO.M444B STRETCHER RD, NTINDA, KAMPALA

KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506

CLOBETASOL-17-BUTYRATE + GENTAMYCIN SULPHATE + MICONAZOLE NITRATE

0.05%W/W+0.1%W/W+2%W/W

KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506

KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506

DICLOFENAC DIETHYLAMINE+ LINSEED OIL+ METHYL SALICYLATE +MENTHOL

11.6MG + 30MG + 100MG + 50MG

KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506

KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506

KREMOINT PHARMA PVT LTD---B-8 ADDITIONAL AMBERNATH MIDC OPP. ANAND NAGAR POLICE CHECK POST AMBERNATH (E) DIST THANE 421 506

KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA

Page 529: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACICLOVIR 5%W/W INDIA

HYDROGEN PEROXIDE 6%W/V UGANDA

AMOXICILLIN + CLAVULANIC ACID 875MG + 125 MG SLOVENIA

RACECADOTRIL 100 MG FRANCE

RACECADOTRIL 10 MG FRANCE

RACECADOTRIL 30 MG FRANCE

NYSTATIN 100.000 I.U KENYA

ACETYL SALICYLIC ACID 300MG KENYA

CLOTRIMAZOLE 100MG KENYA

CLOXACILLIN 250MG KENYA

KREMOINT PHARMA PVT LTD-B-8,ADDITIONAL AMBERNATH MIDC, AMBERNATH (E),DIST: THANE 421506, INDIA

KWALITY AFRO-ASIA LTD-PLOT 165 KAWEMPE BOMBO ROAD

LABESFAL LABORATORIES ALMIRO S.A-LAGEDOSANT, SOLVENIA

LABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE

LABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE

LABORATOIRES SOPHARTEX-21 RUE DU PRESSOIR, 28500 VERNOUILLET, FRANCE

LABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI

LABORATORY & ALLIED LTD.-PLOT 209/10349 OFF MOMBASA RD NAIROBI

LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI

LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI

Page 530: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOTRIMAZOLE 1%W/W KENYA

CLOXACILLIN 125MG/5ML KENYA

BETAMETHASONE VALERATE 0.1%W/W KENYA

MEBENDAZOLE 100MG KENYA

AMPICILLIN 125MG/5ML KENYA

PHENOXYMETHYLPENICILLIN 250MG KENYA

CO-TRIMOXAZOLE 480MG KENYA

HYDROCORTISONE 1%W/W KENYA

DOXYCYCLINE 100MG KENYA

BETAMETHASONE VALERATE 0.1%W/W KENYA

LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI

LABORATORY & ALLIED LTD.---PLOT 209/10349 OFF MOMBASA RD NAIROBI

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

Page 531: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PARACETAMOL 500MG KENYA

LEVAMISOLE HYDROCHLORIDE 40MG KENYA

CHLORPHENIRAMINE MALEATE 4MG KENYA

AMPICILLIN 250MG KENYA

DICLOFENAC 1%W/W KENYA

AMOXYCILLIN TRIHYDRATE 125MG/5ML KENYA

FERROUS SULPHATE +FOLIC ACID 200MG+0.4MG KENYA

FERROUS SULPHATE 200MG KENYA

FOLIC ACID 5MG KENYA

METHYLDOPA 250MG KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD--PLOT NO. 209/ 10349, OPP. SAMEER BUSINESS PARK, MOMBASA ROAD P.O. BOX 42875, GPO 00100, NAIROBI, KENYA

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

Page 532: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACETAMINOPHEN 500MG KENYA

BENZOIC ACID + SALICYLIC ACID 6%W/W + 3%W/W KENYA

250MG +250 MG KENYA

ASPRIRIN+CAFFEINE 350MG+30MG KENYA

AMOXYCILLIN 250MG KENYA

HYDROCORTISONE 1%W/W KENYA

GLIBENCLAMIDE 5 MG INDIA

CEFEPIME HCL 1000MG INDIA

CHLORPHENIRAMINE 4MG INDIA

INDIA

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

AMPICILLIN TRIHYDRATE + CLOXACILLIN SODIUM

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY & ALLIED LTD-PLOT NO. 209/10349OFF MOMBASA ROAD, NAIROBI P.O. BOX 42875, NAIROBI, KENYA.

LABORATORY AND ALLIED LTD-PLOT 209/10349-MOMBASA ROAD NAIROBI

LA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIA

LA-MED HEALTHCARE PVT LTD-1389 TRASAD ROAD, DHOLKA, AHMEDABAD, GUJARAT INDIA

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

BECLOMETHASONE+MICONAZOLE+NEOMYCIN

0.025%W/W + 2%W/W + 0.5%W/W

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

Page 533: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IBUPROFEN 200MG INDIA

FOLIC ACID 5MG INDIA

SALBUTAMOL 2MG/5ML INDIA

INDOMETHACIN 25MG INDIA

CLOXACILLIN SODIUM 125MG/5ML INDIA

AZITHROMYCIN 500MG INDIA

CEFIXIME 200MG INDIA

CEFIXIME TRIHYDRATE 50MG/5ML INDIA

DICLOFENAC SODIUM 100MG INDIA

DOXYCYCLINE 100MG INDIA

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

LEBEN LAB PVT LTD-L4 PHASE 111 MIDCS AKOLA 444104 MAHARASTRA INDIA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

Page 534: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

GRISEOFULVIN 500 MG INDIA

METRONIDAZOLE 125MG/5ML INDIA

METRONIDAZOLE 200MG INDIA

OMEPRAZOLE 20MG INDIA

SALBUTAMOL 4MG HONG KONG

CHLORPHENIRAMINE 2MG/5ML INDIA

PARACETAMOL 120MG/5ML INDIA

CLOXACILLIN 250MG INDIA

CHLORPROMAZINE 100MG INDIA

DRIED ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE

400MG + 400MG + 50MG

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

Page 535: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

PARACETAMOL 500MG INDIA

CHLORAMPHENICOL PALMITATE 125MG/5ML INDIA

NYSTATIN 100000IU/ML INDIA

400MG + 80MG INDIA

DICLOFENAC SODIUM TABLETS BP 50MG INDIA

PRAZIQUANTEL 600MG INDIA

PROPRANOLOL HYDROCHLORIDE 40 MG INDIA

INDIA

CIPROFLOXACIN 500MG INDIA

TERBUTALINE/ BROMHEXINE/ GUAIPHENESIN

1.25MG/ 4MG/ 50 MG

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

SULFAMETHOXAZOLE + TRIMETHOPRIM

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

LEBEN LABORATORIES PVT LTD --L4 PHASEIII M.I.D.C AKOLA 444 104 MAHARASHTRA

CLOBETASOL PROPIONATE + GENTAMYCIN + MICONAZOLE NITRATE

0.05%W/W + 0.10%W/W + 2.0%W/W

LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.

LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.

Page 536: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

AMOXICILLIN 250MG INDIA

COTRIMOXAZOLE 240MG/5ML INDIA

CO-AMOXICLAV 400MG+47MG/ 5ML SWITZERLAND

CO-AMOXICLAV SWITZERLAND

ROSUVASTATIN CALCIUM 10MG SLOVENIA

ATORVASTATIN 40MG SLOVENIA

ATORVASTATIN 20MG SLOVENIA

SLOVENIA

BISOPROLOL FUMARATE 2.5MG GERMANY

ALUMINIUM HYDROXIDE + MAGNESIUM + SIMETHICONE

400MG + 400MG + 50MG

LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.

LEBEN LABORATORIES PVT. LTD.-PLOT NO. L-4, PHASE –III, M.I.D.C, AKOLA, 444104, MAHARASHTRA, INDIA.

LEBEN LABORATORIES PVT. LTD-L-4, PHASE –III, M.I.D.C,

LEK D.D PREVALJE SDOVENIA-DORNACHERSTASSE 144 P.O.BOX 445,CH 4147 AESCH (BASEL) SWITZERLAND

125MG+31.25MG/ 5ML

LEK D.D PREVALJE SDOVENIA-DORNACHERSTASSE 144 P.O.BOX 445,CH 4147 AESCH (BASEL) SWITZERLAND

LEK PHARMACEUTICALS .D.D -VEROVSKOVA 57, 1526 LJUBLJANASLOVENIA

LEK PHARMACEUTICALS-D.D VEROVŠKOVA 57, 1526 LJUBLJANA SLOVENIA

LEK PHARMACEUTICALS-D.D VEROVŠKOVA 57, 1526 LJUBLJANA SLOVENIA

LACTOBACILLUS ACIDOPHILUS + BIFIDOBACTERIUM INFANTIS + ENTEROCOCCUS FAECIUM

1.2 * 10 TO POWER 7 COLONY FORMING UNITS OF VIABLE LACTIC ACID BACTERIA SPECIES

LEK PHARMACEUTICALS-D.D VEROVŠKOVA 57, 1526 LJUBLJANA SLOVENIA

LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW

Page 537: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BISOPROLOL 5 MG GERMANY

METFORMIN HYDROCHLORIDE 1000MG POLAND

METFORMIN HYDROCHLORIDE 500MG POLAND

BISOPROLOL FUMARATE 10MG POLAND

GLIMEPIRIDE 2MG POLAND

GLIMEPIRIDE 4MG POLAND

GLIMEPIRIDE 1MG POLAND

GLIMEPIRIDE 3MG POLAND

20MCG/ML SOUTH KOREA

PARACETAMOL 500MG

LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW

LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW

LEK S.A.-16 PODLIPIE STR. 95-010 STRYKOW

LEK S.A-95 - 010 STRYKÓW, PODLIPIE 16, POLAND,SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE

LEK S.A--U1, PODLIPIE 16, 95-0140 STRYKOW POLAND

LEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATES

LEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATES

LEK S.S POLAND UI PODLIPIE 16 95-01O STRYKOW-INDUSTRIAL ESTATES

HEPATITIS B VACCINE, RECOMBINANT

LG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JE

LIFE PHARMA FZE --JEBEL ALI FREE ZONE, PLOT NO. MO 0502, P.O. BOX 17404, DUBAI-UAE

UNITED ARAB EMIRATES

Page 538: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

30MG+1.25MG/5ML LIFEPHARMA FZE .-JEBEL ALI -DUBAI UAE

INSULIN LISPRO LILLY FRANCE SA-FRANCE FRANCE

25I.U+75I.U LILLY FRANCE SA-FRANCE FRANCE

INSULIN LISPRO 100IU LILLY FRANCE SA-FRANCE FRANCE

ADRENALINE 0.1% W/V INDIA

PARACETAMOL 150MG/ML INDIA

VITAMIN B COMPLEX N/A INDIA

ARTESUNATE 60MG INDIA

INDIA

ARTEMETHER 80MG/ML INDIA

PSEUDOEPHEDRINE DROCHLORIDE+HYTRIPROLIDINE HYDROCHLORIDE

UNITED ARAB EMIRATES

100 .IU(50 I.U+50 I.U)

INSULIN LISPRO + INSULIN LISPRO PROTAMINE

LINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT

LINCOLN PARENTERAL LTD -11 TRIUL ESTATE KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT

LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT

LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT

FERRIC AMMONIUM CITRATE+ FOLIC ACID+PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE

50MG + 0.55MG +2.4MG + 1.2MG +11MG /5ML

LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-38272, GUJARAT

LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-382721, GUJARAT

Page 539: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

100MG INDIA

ONDASENTRON 2MG/ML INDIA

5MG+500MG INDIA

ACICLOVIR 5%W/W INDIA

FLUCONAZOLE 200MG INDIA

PANTOPRAZOLE 40MG INDIA

ATORVASTATIN 20MG INDIA

DOMPERIDONE 10MG INDIA

OFLOXACIN 200MG INDIA

CO-TRIMOXAZOLE 480MG INDIA

HYDROCORTISONE SODIUM SUCCINATE

LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-382721, GUJARAT

LINCOLN PARENTERAL LTD-11, TRIMUL ESTATE KHATRAJ DISI. GANDHINAGAR-382721, GUJARAT(

GLIBENCLAMIDE+METFORMIN HYDROCHLORIDE TABLETS

LINCOLN PHARMACEUTICAL LIMITED..-LINCOLN PHARMACEUTICALS LIMITED, TRIMUL ESTATE, KHATRAJ, TAL. KALOL, DIST. GANDHINAGAR

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

Page 540: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

N/A INDIA

INDIA

KETOCONAZOLE 2% W/W INDIA

TRAMADOL HYDROCHLORIDE 50MG INDIA

METFORMIN 500MG INDIA

150MG + 1G + 1G INDIA

1MG + 500MG INDIA

2MG + 500MG INDIA

1250MG + 250 I.U INDIA

INDIA

DICLOFENAC DIETHLAMINE/LINISEED OIL/METHYL SALICYLATE MENTHOL

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

PARACETAMOL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/CHLORPHENIRAMINE MALEATE

500MG/10MG/15MG/2MG

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

LINCOLN PHARMACEUTICAL LIMITED-TRIMAL ESTATE KHATRAJ KOLOL,GUJARAT INDIA

FLUCONAZOLE + AZITHROMYCIN + SECNIDAZOLE

LINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT

GLIMEPIRIDE+METFORMIN HYDROCHLORIDE

LINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT

GLIMEPIRIDE+METFORMIN HYDROCHLORIDE

LINCOLN PHARMACEUTICALS L.T.D-TRIMUL ESTATE KHATRAJ 382721 GHANDINAGAR GUJARAT

CALCIUM CARBONATE + COLECALCIFEROL

LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LANSOPRAZOLE + CLARITHROMYCIN + TINIDAZOLE

30MG + 250MG + 500MG

LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

Page 541: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LEVOFLOXACIN 500 MG INDIA

ONDANSETRON 8MG INDIA

ONDANSETRON 4MG INDIA

SECNIDAZOLE 1000MG INDIA

TINIDAZOLE 500MG INDIA

MEFENAMIC ACID 500MG INDIA

10MG + 10MG INDIA

CLARITHROMYCIN TABLETS 500MG INDIA

50MG + 12.5MG INDIA

PARACETAMOL SUSTAINED RELEASE 1000MG INDIA

LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA LINCOLN PHARMACEUTICALS LIMITED -10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

DOXYLAMINE SUCCINATE & PYRIDOXINE HYDROCHLORIDE

LINCOLN PHARMACEUTICALS LIMITED.-TRIMUL ESTATE NEAR KHATRAJ CHOKADI KHATRAJ 382721 GHANDHINAGAR GUJARAT

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LOSARTAN + HYDROCHLOROTHIAZIDE

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

Page 542: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DOXYCYLINE 100MG INDIA

INDIA

5%W/W / 1%W/W INDIA

NIFEDIPINE 20MG INDIA

INDIA

AZITHROMYCIN 250MG INDIA

OMEPRAZOLE 20MG INDIA

AZITHROMYCIN 500MG INDIA

ACYCLOVIR 500MG INDIA

ARTEMETHER 80MG/ML INDIA

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

PARACETAMOL + CHLORPHENIRAMINE MALEATE + CAFFEINE + PHENYLEPHRINE HCL

500MG+ 2MG+ 2MG + 30MG

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

POVIDONE IODINE / METRONIDAZOLE

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

CLOBETASOL+GENTAMICIN+MICONAZOLE

0.05%W/W+0.1%W/W+2%W/W

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LIMITED-10, 12, 13, TRIMUL ESTATE, AFTER VADSCAR VILLAGE, NEAR KHATRAJ CHOKADI, KHATRAJ-382721, GHANDHINAGAR, GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

Page 543: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ATORVASTATIN 40MG INDIA

CLARITHROMYCIN 500MG INDIA

CLOTRIMAZOLE 2%W/W INDIA

DICLOFENAC 1%W/W INDIA

INDIA

INDIA

LOSARTAN POTASSIUM 50MG INDIA

1%W/W + 0.2%W/W INDIA

PARACETAMOL 500MG INDIA

POVIDINE IODINE 10 %W/V INDIA

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

DICLOFENAC/SALICYLATE/MENTHOL/LINSEED

1%W/W+10%W/W+5%W/W+3%W/W

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LANSOPRAZOLE DELAYED RELEASE + CLARITHROMYCIN+ TINIDAZOLE

30MG + 250MG + 500MG

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

SILVER SULFADIAZINE + CHLORHEXIDINE

LINCOLN PHARMACEUTICALS LTD .-10,12,13 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR

GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA

Page 544: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DICLOFENAC SODIUM 50MG INDIA

CLOTRIMAZOLE 100MG INDIA

IBUPROFEN 200MG INDIA

QUININE SULPHATE 300MG INDIA

BETAMETHASONE + NEOMYCIN 0.1 W/W + 0.5 W/W INDIA

MAGNESIUM SULPHATE 50%W/V INDIA

CIPROFLOXACIN 500MG INDIA

INDIA

ALBENDAZOLE 400MG INDIA

FLUCONAZOLE 150MG INDIA

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD-10, 11, 13, TRIMUL ESTATE KHATRAJ, NEAR KHATRAJ, CHOKADI , KHATRAJ-382721, GHANDINAGAR GUJARAT, INDIA

LINCOLN PHARMACEUTICALS LTD--11 TRIMUL ESTATE, NEAR KHATRAJ CHOKADI, P.O. KHATRAJ-382721 TA: KALOL, DIST. GANDHINAGAR, GUJARAT

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

PARACETAMOL + PHENYLEPHRINE HCL + DEXTROMETHORPHAN HBR + CHLORPHENIRAMINE MALEATE

250MG + 5MG + 10MG + 2MG

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

Page 545: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GENTAMICIN 0.3%W/V INDIA

CLOTRIMAZOLE 1%W/W INDIA

METFORMIN HYDROCHLORIDE 500MG INDIA

SULPHADOXINE + PYRIMETHAMINE 500MG + 25MG INDIA

MICONAZOLE 2%W/W INDIA

ACECLOFENAC + PARACETAMOL 100 MG + 325 MG INDIA

TRAMADOL HYDROCHLORIDE 50MG GERMANY

LATANOPROST 0.005%W/V CHINA

CEFIXIME 400MG INDIA

CEFIXIME 100MG/5ML INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA

LINCOLN PHARMACEUTICALS LTD-TRIMUL ESTATE AT & POST KHATRAJ TAL KALOL DIST GANDHINAGAR GUJARAT

LOSAN PHARMA GMBH- OTTO-HAHN-STR 13 79395 NEUENBURG

LUNAN BETTER PHARMACEUTICAL CO., LTD.-NO.209, HONGQI AVENUE, LANSHAN DISTRICTLINYI, SHANDONG, 276006 CHINA+86-5398331258 †

LUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIA

LUPIN LIMITED--198-202, NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, BHOPAL-462 046, DIST. RAISEN, MADIA PRADESH INDIA

Page 546: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INSULIN ISOPHANE 100 I.U/ML INDIA

MEROPENEM 1G INDIA

CEFEPIME 500MG INDIA

INSULIN ZINC SUSPENSION 100 I.U/ML INDIA

INSULIN SOLUBLE 100 IU/ML INDIA

OMEPRAZOLE 20 MG INDIA

CEFUROXIME 750MG INDIA

GLIBENCLAMIDE 5MG INDIA

MEROPENEM 0.5G INDIA

METFORMIN HYDROCHLORIDE 500MG INDIA

M.J .BIOPHARM-L7, M.I.D.C INDUSTRIAL AREA TALOJA, NAVI MUMBAI MAHARAHTRA

M.J BIOPHARM PUT LTD -L-7 MIDC INDUSTRIOL DIST GAIDED TOLOJA

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

M.J BIOPHARM PVT LTD --L-7 MIDC INDUSTRIAL AREA, DIST . RAIGAD , TALOJA , NAVI MUMBAI

Page 547: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LORATADINE 10MG INDIA

ADRENALINE IMG/ML INDIA

CEFEPIME 1000MG INDIA

AMINOPHYLLINE 25MG/ML INDIA

CEFTRIAXONE 1G INDIA

INDIA

AZITHROMYCIN 500MG INDIA

TADALAFIL 20MG INDIA

LEVOFLOXACIN HEMIHYDRATE 750MG INDIA

37.5MG+325MG INDIA

M.J BIOPHARM PVT LTD --L-7 MIDC TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI

M.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI

M.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI

M.J BIOPHARM PVT LTD-TALOJA DISTRICT RAIGAD 410208 NAVI MUMBAI

M.J.BIOPHARM PVT LTD-L-7 MIDC INDUSTRIAL AREA TALOYA NAVI MUMBAI

EFAVIRENZ + LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE

600MG + 300MG + 300MG

MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA

MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA

MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIA

MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA

TRAMADOL HYDROCHLORIDE+ACETAMINOPHEN

MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA

Page 548: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LINEZOLID 600MG INDIA

PREGABALIN 75MG INDIA

PRAZIQUANTEL 600MG INDIA

FEBUXOSTAT 80MG INDIA

ZINC SULFATE MONOHYDRATE 20MG INDIA

CAPREOMYCIN 1000MG INDIA

CYCLOSERINE 250MG INDIA

INDIA

ETHIONAMIDE 250MG INDIA

KANAMYCIN 1G INDIA

MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA

MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA

MACLEODS PHARMACEUTICALS LIMITED -BLOCK-N2 VILLAGE THEDA POST OFFICE LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH – 174101 INDIA

MACLEODS PHARMACEUTICALS LTD - - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101

MACLEODS PHARMACEUTICALS LTD - - VILLAGE THEDA P.O LODHIMAJRA TEHSIL BADDI DISTRICT SOLAN HIMACHAL PRADESH INDIA 174101

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

EFAVIRENZ + EMTRICITABINE + TENOFOVIR

600MG + 200MG + 300MG

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

Page 549: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

300MG INDIA

KETOCONAZOLE 200 MG INDIA

EFAVIRENZ 600MG INDIA

ZIDOVUDINE 300MG INDIA

AMLODIPINE BESILATE 10MG INDIA

INDIA

ATORVASTATIN 20MG INDIA

ATORVASTATIN 10MG INDIA

INDIA

CO-TRIMOXAZOLE 480MG INDIA

TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

RIFAMPICIN + ISONIAZID + PYRAZINAMIDE + ETHAMBUTOL

150MG + 75MG+ 400MG + 275MG

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

RIFAMPICIN+ISONIAZID+ETHAMBUTOL

150MG+75MG+275MG

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

Page 550: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

200MG + 300MG INDIA

LOPINAVIR + RITONAVIR 200MG + 50MG INDIA

LEVOFLOXACIN 500MG INDIA

LEVOFLOXACIN 250MG INDIA

RABEPRAZOLE SODIUM 20MG INDIA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG INDIA

CO-TRIMOXAZOLE 240MG/5ML INDIA

LOPINAVIR + RITONAVIR 100MG + 25MG INDIA

ISONIAZID 300MG INDIA

MONTELUKAST SODIUM 5 MG INDIA

EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD .-PLOT 25-27 SURVEY NO. 366 PREMEIRE INDUSTRIAL ESTATE KACHIGAN DAMAN 396210 INDIA

MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.

MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.

MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.

MACLEODS PHARMACEUTICALS LTD -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA.,OXALIS LABS -VILLAGE THEDA P.O LODHIMAJRA, THESIL BADDI DISTRICT SOLAN HIMACHAL PRADESH MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101

MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101

MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101

MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101

Page 551: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

LAMIVUDINE + ZIDOVUDINE 150MG + 300MG INDIA

ROSUVASTATIN CALCIUM 20MG INDIA

INDIA

RIFAMPICIN + ISONIAZID 75MG + 50MG INDIA

BISACODYL 5MG INDIA

NEVIRAPINE 200MG INDIA

RIFAMPACIN + ISONIAZID 60 MG + 30 MG INDIA

LAMIVUDINE 150MG INDIA

MOXIFLOXACIN 400MG INDIA

LAMIVUDINE + ZIDOVUDINE + NEVIRAPINE

150MG + 300MG + 200MG

MACLEODS PHARMACEUTICALS LTD(BLOCK N2)-VILLAGE THEDA,P.O LODHI MAJRA,TEHSIL BADDI,HIMACHAL PRADESH 174101,MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMANMACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN

MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN

RIFAMPICIN + ISONIAZID + PYRAZINAMIDE

75MG + 50MG + 150MG

MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN

MACLEODS PHARMACEUTICALS LTD., NO. 25-27-PLOT NO. 25-26-27, SURVEY NO.366, PREMIER INDUSTRIAL ESTATE ., DAMAN - 396210, KACHIGAM, DAMAN

MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.

MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.

MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.

MACLEODS PHARMACEUTICALS LTD.-PLOT NO. 25-27 SURVEY NO. 366,PREMIER INDUSTRIAL ESTATE, KACHIGAM,DAMAN (UT) - 396210, INDIA.

MACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN

Page 552: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

STREPTOMYCIN 1G INDIA

PARA-AMINOSALICYLATE SODIUM 60%W/W INDIA

PYRAZINAMIDE 500MG INDIA

CO-TRIMOXAZOLE 120MG INDIA

300MG +300MG INDIA

TRANEXAMIC ACID 500MG INDIA

CLOPIDOGREL 75MG INDIA

QUININE SULPHATE 300MG INDIA

ESOMEPRAZOLE 40MG INDIA

ONDANSETRON 4MG INDIA

MACLEODS PHARMACEUTICALS LTD--PLOT 25-27 SURVEY NO. 366 PREMIER INDUSTRIAL ESTATE KACHIGAM DAMAN

MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401

MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401

MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401

LAMIVUDINE + TENOFOVIR DISOPROXIL FUMARATE

MACLEODS PHARMACEUTICALS LTD---PLOT NO 25-27 SURVEY PREMEIRE INDUSTRIAL ESTATE KACHIGAM DAMAN (U.T) 396401,MACLEODS PHARMACEUTICALS LIMITED (BLOCK –N1)-VILLAGE THEDA, P.O. LODHI MAJRA,TEHSIL BADDI, HIMACHAL PRADESH -174101,INDIAMACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA

MACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA

MACLEODS PHARMACEUTICALS -PLOT NO. 25-27, SURVEY NO. 366, PREMIER INDUSTRIAL ESTATE, KACHIGAM DAMAN (UT), INDIA

MADRAS PHARMACEUTICALS -137-B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI – 600 096, INDIA

MANKIND PHARMA LIMITED, UNIT-II. -VILLAGE KISHANPURA, P.O JAMNIWALA, PAONTA SAHIB IN H.P.

Page 553: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ONDASENTRON 8MG INDIA

ONDANSENTRON HYDROCHLORIDE 2MG/ML INDIA

CHOLECALCIFEROL 60000IU INDIA

ONDANSETRON 4MG/5ML INDIA

CEFTRIAXONE+SULBACTAM 1000MG+500MG INDIA

ARTESUNATE+AMODIAQUINE 50MG+135MG MOROCCO

ARTESUNATE+AMODIAQUINE 25MG+67.5MG MOROCCO

ARTESUNATE+AMODIAQUINE 100MG+270MG MOROCCO

LEVOFLOXACIN 500MG/100ML INDIA

CARVEDILOL 25MG EGYPT

MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH

MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH

MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH

MANKIND PHARMA LTD--UNIT II VILLAGE KISHANPURA P.O JAMNIWALA TEHSIL PAONTA SAHIB DISTRICT SIRMOUR 173 025 HIMACHAL PRADESH

MANKIND PHARMA LTD--VILLAGE KISHANPURA P.O JAMNI WALA TEHSIL PAONTA SAHIB DISTT SIRMOUR 173025 HIMACHAL PRADESH

MAPHAR LABORATORIES-KM7 ROUTE DE ROBAT AIN SEBAA CASABLANCA MOROCCO

MAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCO

MAPHAR S.A. GROUP OF SANOFI,-KM 10, ROUTE COTIERE 111 QUARTIER, INDUSTRIEL ZENATA AIRI SEBAA, 00212522678099 - MOROCCO

MARCK BIOSCIENCES -PLOT NO 876, NH NO 8 HARIYALA KHEDA- 387411 GUJARAT, INDIA

MARCYRL PHARMACEUTICAL INDUSTRIES -WESTERN EXTEENSION-PARTS NUMBER 5/6/7/8/9/10/11/12-BLOCK 20005, EL OBOUR CITY

Page 554: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EGYPT

UGANDA

UGANDA

POVIDINE-IODINE 10 %W/V UGANDA

HYDROGEN PEROXIDE 6 %W/V UGANDA

UGANDA

MULT-INGREDIENT N/A UGANDA

CALAMINE + ZINC OXIDE UGANDA

UGANDA

KETOCONAZOLE 200MG INDIA

EXTRACT CEPAE FLUID +HEPARIN SODIUM+ALLANTOIN

10G+5000 I.U+1G/100G

MARCYRL PHARMACEUTICAL INDUSTRIES.-EL OBOUR CITY CAIRO

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

SODIUM BICARBONATE + LIGHT MAGNESIUM CARBONATE + MAGNESIUM

250 MG + 250 MG + 250 MG

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

DIPHENHYDRAMINE HYDROCHLORIDE + SODIUM CITRATE + AMMONIUM CHLORIDE

0.014 MG / 5 ML + 0.057 MG / 5 ML + 0.135 MG / 5 ML

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

0.75 MG / 5 ML + 0.25 MG / 5 ML

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

CHLORHEXIDINE GLUCONATE 20% + CETRIMIDE

0.015 G / 5 ML +0.15 G / 5 ML

MAVID PHARMACEUTICAL INDUSTRIES LIMITED-PLOT 490 BIRONGO, KITIIKO

MAXHEAL PHARMACEUTICALS INDIA LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

Page 555: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LEVOCETIRIZINE 5MG INDIA

ACECLOFENAC 100MG INDIA

DICLOFENAC SODIUM 50MG INDIA

INDIA

PARACETAMOL/CAFFEINE TABLETS 500MG/65MG INDIA

MULTIINGREDIENT N/A INDIA

PARACETAMOL/IBUPROFEN 325/400MG INDIA

MEFENAMIC ACID 500MG INDIA

NYSTATIN 100,000 IU INDIA

ALBENDAZOLE 400MG INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD - J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

VITAMIN B1 + VITAMIN B2 + VITMAIN B6 + VITAMIN B12 + FOLIC ACID + VITAMIN B5 + CALCIUM GLUCONATE + VITAMIN B3 + IRON + ZINC SULPHATE + COPPER SULPHATE + MANGANESE CHLORIDE + LYSINE HCL + HONEY +

MG PER 5ML: 5 + 1 + 1 + 5 + 50 + 2 + 20 + 10 + 10 + 3 + 0.2 + 0.25 + 20 + 100 + 100

MAXHEAL PHARMACEUTICALS INDIA LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD - -J-7 MIDC, TARAPUR INDUSTRIAL AREA, BOISAR- 401506, DIST.THANE, MARAHASHTRA, INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD .-J-7,MIDC,TARAPUR INDUSTRIAL ALLA,BOISAR DIST-THANE,MEHARASHTRA

MAXHEAL PHARMACEUTICALS INDIA LTD -J-Z MIDC, TARAPUR INDUSTRIAL AREA, BOISAR-401506,DIST.THANE, MARAHASHTRA,INDIA

MAXHEAL PHARMACEUTICALS INDIA LTD.--J-7,MIDC,TARAPUR INDUSTRIAL AREA,BOISAR 401 506 DIST-THANE,MEHARASHTRA

MAXHEAL PHARMACEUTICALS INDIA LTD-J-7,MIDC,TARAPUR INDUSTRIAL ALLA, BOISAR 401 506 DIST THANE,MEHARASHTRA

Page 556: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

HYDROCORTISONE+CINCHOCAINE EGYPT

AMOXYCILLIN TRIHYDRATE 125MG/5ML EGYPT

MAGALDRATE+SIMETHICONE 720MG+25MG INDIA

MICONAZOLE 2%W/W EGYPT

MICONAZOLE NITRATE 2%W/W EGYPT

EGYPT

CARBOCISTEINE 125 MG/5 ML EGYPT

EGYPT

PIROXICAM 0.5%W/V EGYPT

EGYPT

0.5%W/W + 0.5%W/W

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

HYDROCORTISONE+ CINCHOCAINE+ ESCULOSIDE+ FRAMYCETIN

5MG + 5MG +10MG +10MG

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

PARACETAMOL/ DIPHENHYDRAMINE CHLORIDE + PARACETAMOL/ PSEUDOEPHEDRINE

500MG/ 25MG +600MG/ 90MG

MEDICAL UNION PHARMA .CO-ABU-SULTAN ISMAILIA EGYPT

MEDICAL UNION PHARMACEUTICALS CO -36 DR MOHAMED HASSAN EL GAMAL ST. 6TH DISTRICT NASR CITY, CAIRO

VITAMIN A+ VITAMIN D3+VITAMIN E+ VITAMIN C +VITAMIN B1 + VITAMIN B2

1500IU+ 400IU+ 5MG+ 40MG+0.5MG+0.6MG

MEDICAL UNION PHARMACEUTICALS -HEAD OFFICE 36 6TH DISTRICT NASR CITY CAIRO EGYPT PLANT ABUSULTAN ISMAILIA

Page 557: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMPICILLIN + SULBACTAM 1000 MG + 500 MG EGYPT

LACTULOSE 67G/100ML EGYPT

SILYMARIN 140MG EGYPT

SILYMARIN 1G/100ML EGYPT

EGYPT

PIROXICAM 20MG EGYPT

20MG EGYPT

MEBENDAZOLE 100MG/5ML INDIA

200MG/40MG INDIA

ZINC SULPHATE 20MG INDIA

MEDICAL UNION PHARMACEUTICALS LTD - -ABU SULTAN, CR 13363 ISMAILLIA, EGYPT

MEDICAL UNION PHARMACEUTICALS LTD-ABU SULTAN, ISMAILLIA, EGYPT

MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT

MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT

NEOMYCIN SULPHATE + BACITRACIN

165,000 IU + 12,500 IU

MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT

MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT

ATORVASTATIN CALCIUM TRIHYDRATE

MEDICAL UNION PHARMACEUTICALS-36 DR MOHAMED HASSAN EL-GAMAL ST.6TH DISTRICT NASR CITY EGYPT

MEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA

SULFAMETHOXAZOLE/TRIMETHOPRIM

MEDICAMEN BIOTECH LTD - -SP-1192 A&B PHASE IV INDUSTRIAL AREA BHIWADI 301019 DIST. ALWAR (RAJASTHAN) - INDIA

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

Page 558: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ALBENDAZOLE 400MG INDIA

800MG + 160MG INDIA

ERYTHROMYCIN 100MG INDIA

DOXYCYCLINE 100MG INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

PHENOXYMETHYLPENICILLIN 250MG INDIA

AMOXICILLIN 125MG/5ML INDIA

QUININE SULPHATE 300MG INDIA

ZINC SULPHATE 20MG INDIA

FERROUS IRON + FOLIC ACID 65MG + 0.4MG INDIA

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

SULPHAMETHOXAZOLE + TRIMETHOPRIM

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

MEDICAMEN BIOTECH LTD-SP-1192, A &B, PHASE –IV,INDUSTRIAL AREA BHIWADI -301019 DIST. ALWAR (RAJASTHAN)

Page 559: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

UGANDA

CEFOTAXIME 1GM INDIA

ATORVASTATIN CALCIUM 20MG INDIA

INDIA

ATORVASTATIN 10MG INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

MULTIVITAMIN/ DIASTASE/PEPSIN MULTI-INGREDIENT INDIA

CIPROFLOXACIN HYDROCHLORIDE 500MG INDIA

PANTOPRAZOLE 40MG INDIA

AMLODIPINE BESYLATE 5MG INDIA

GLUCOSE ANHYDROUS + TRISODIUM CITRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE

6.75G + 1.45G + 1.3G + 0.75G / SACHET

MEDIPHARM INDUSTRIES( EA) LTD-PLOT 65 KAKAJJO ROAD BWEYOGERERE P.O.BOX 6218,KAMPALA,UGANDA

MEDISPRAY LABORATORIES PVT LTD --L-1/1, L-1/2/2, ADDITIONAL MIDC SATARA 415004

MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM

LANSOPRAZOLE + TINIDAZOLE + CLARITHROMYCIN

30MG +500MG + 250MG

MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM

MEDLEY PHARMACEUTICALS LTD,-PLOT 18 & 19 SURVEY NO 378/7 & 379/ 2&3 ZARI CAUSEWAY ROAD KACHIGAM

MEDLEY PHARMACEUTICALS LTD,-PLOT NO 11, SURVEY NO.

MEDLEY PHARMACEUTICALS LTD,-PLOT NO 11, SURVEY NO.

MEDLEY PHARMACEUTICALS LTD..-PLOT NO. 18 & 19, SURVEY NO.378/7&8, 379/2&3,ZARI CAUSEWAY ROAD, KACHIGAM,DAMAN (U.T) 396210-INDIA

MEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210

MEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210

Page 560: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LEVOCETIRIZINE DIHYDROCHLORIDE 5MG INDIA

ACECLOFENAC TABLETS 100 MG INDIA

RABEPRAZOLE SODIUM 20MG INDIA

OMEPRAZOLE 20MG INDIA

INDIA

DICLOFENAC SODIUM 100MG INDIA

INDIA

INDIA

DOMPERIDONE 10MG INDIA

INDIA

MEDLEY PHARMACEUTICALS LTD-PLOT NO 18 & 19, SURVEY NO. 378/7& 8,379/2&3 ZARI CAUSEWAY ROAD,, KACHIGAM, DAMAN-396 210

MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA

MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA

MEDLEY PHARMACEUTICALS LTD-PLOT NO.18 AND 19, SURVEY NO.378/8 & 379/2, KEBRA INDUSTRIAL ESTATE, KACHIGAM, DAMAN-396210 INDIA

DEXTROMETHOPHAN HBR + PHENYLEPHRINE HCL + MENTHOL

10MG/ML + 5MG/10ML + 5MG/10ML

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

PARACETAMOL+CHLORPHENIRAMINE MALEATE+PHENYLEPRINE HYDROCHLORIDE + CAFFEINE

500MG+2MG+5MG+15MG

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

FERROUS GLUCONATE + VITAMIN C + VITAMIN B12 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + CALCIUM PANTOTHENATE + VITAMIN B3 + FOLIC ACID + DIBASIC CA PO4 + ZINC SULPHATE

200MG + 38MG + 4MCG + 3MG + 2.5MG + 1MG + 2.5MG + 1MG + 2.5MG + 23MG + 0.5MG + 100MG + 33MG

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

CETIRIZINE DIHYDROCHLORIDE + PHENYLEPHRINE HCL + PARACETAMOL

2.5MG + 5MG + 125MG

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

Page 561: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT N/A INDIA

CEFAZOLIN 1000MG CYPRUS

CEFUROXIME 750MG CYPRUS

MEROPENEM 1G CYPRUS

CEFIXIME TRIHYDRATE 400MG CYPRUS

CLARITHROMYCIN 500MG CYPRUS

LISINOPRIL DIHYDRATE 10MG CYPRUS

CEFTRIAXONE 1G CYPRUS

CARVEDILOL 25MG CYPRUS

800MG +160MG INDIA

MEDLEY PHARMACEUTICALS, LTD-PLOT 18/19 ZORIC CORSE WAY ROAD KACHIGAM DAMAN

MEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS

MEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS

MEDOCHEMIE LTD COGOLS FACILITY-1-10 CONSTANTINOUPOLEOS STREET, ZAKAKI, LIMASSOL, CYPRUS

MEDOCHEMIE LTD PHARMACEUTICAL INDUSTRY,FACTORY C-2 MICHAEL ERAKLEOUS STREET, AGIOS ATHANASSIOS INDUSTRIALAREA 4101 AGIOS ATHANASSIOUS LIMASSOL CYPRUS

MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL

MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL

MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL

MEDOCHEMIE LTD-1-10 CONSTANTINOUPOLEOS TREET 3011 LIMASSOL

SULFAMETHOXAZOLE + TRIMETHOPRIM

MEDOPHARM -34B INDUSTRIAL AREA MALUR 563130

Page 562: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

800MG +160MG INDIA

AMOXICILLIN + CLAVULANIC ACID 200 MG + 28.5 MG INDIA

AMPICILLIN 250MG INDIA

AMOXICILLIN + CLAVULANATE 200 MG + 28.5 MG INDIA

AMOXICILLIN + CLAVULANIC ACID 500 MG + 125 MG INDIA

250 MG + 125 MG INDIA

500 MG + 125 MG INDIA

AMOXYCILLIN 125MG/5ML INDIA

AMPICILLIN 125 MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

SULFAMETHOXAZOLE + TRIMETHOPRIM

MEDOPHARM -34B INDUSTRIAL AREA MALUR 563130

MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU

MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

AMOXICILLIN + POTASSIUM CLAVULANATE

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

AMOXICILLIN + POTASSIUM CLAVULANATE

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

Page 563: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN 500MG INDIA

AMOXICILLIN 125MG INDIA

AMOXICILLIN 250MG INDIA

AMOXICILLIN 250MG INDIA

INDIA

CO-TRIMOXAZOLE 480MG INDIA

200MG+28.5MG INDIA

875 MG + 125 MG INDIA

200 MG + 28.5 MG INDIA

500 MG + 125 MG INDIA

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

MEDOPHARM PVT LTD.-NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY 603 203 CHENGALPET DISTRICT TAMIL NADU

AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE

200MG/5ML+28.5MG/5ML

MEDOPHARM PVT LTD-50, KAYARAMBEDU VILLAGE, GUDUVANANCHERRY - 603202, TAMIL NADU,

MEDOPHARM--34-B, INDUSTRIAL AREA, MALUR 563 160 KARNATAKE,INDIA

AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE

MEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049

AMOXICILLIN + CLAVULANATE POTASSIUM

MEDREICH LIMITED UNIT 1-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR, BANGOLORE-560049,MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU

AMOXYCILLIN + CLAVULANATE POTASSIUM

MEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA

AMOXYCILLIN + CLAVULANATE POTASSIUM

MEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA

Page 564: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

875 MG + 125 MG INDIA

INDIA

500 MG + 125 MG INDIA

CEFUROXIME AXETIL 250MG INDIA

CEFUROXIME AXETIL 500MG INDIA

FLUCLOXACILLIN 125MG/5ML INDIA

FEXOFENADINE HYDROCHLORIDE 120MG INDIA

FEXOFENADINE HYDROCHLORIDE 180 MG INDIA

FEXOFENADINE HYDROCHLORIDE 60MG INDIA

INDIA

AMOXYCILLIN + CLAVULANATE POTASSIUM

MEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA

AMOXYCILLIN + CLAVULANATE POTASSIUM

125 MG + 31.5 MG/5 ML

MEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA

AMOXICILLIN + POTASSIUM CLAVULANATE

MEDREICH LIMITED –UNIT I-12TH MILE, OLD MADRAS ROAD, VIRGONAGAR BANGALORE-560 049, INDIA,MEDOPHARM PVT LTD -NO. 50 KAYARAMBEDU VILLAGE GUDUVANCHERY-603203 TAMIL NADU

MEDREICH LIMITED UNIT-5-PLOT 45 A & B, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, TELANGANA INDIA

MEDREICH LIMITED UNIT-5-PLOT 45 A & B, ANRICH INDUSTRIAL ESTATE, BOLLARAM, MEDAK DISTRICT, 502 325, TELANGANA INDIA

MEDREICH LIMITED-12TH MIL,OLD MADRAS ROAD,VIRGONAGAR,BANGALORE-560 049,INDIA

MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062

MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062

MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062

FERRIC AMMONIUM CITRATE + CYANOCOBALAMIN + FOLIC ACID

200MG/5ML + 10MG/5ML + 750MCG/5ML

MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062

Page 565: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

ALBENDAZOLE 100/5 INDIA

MULTI INGREDIENT N/A INDIA

CIPROFLOXACIN 500MG INDIA

NORFLOXACIN + TINIDAZOLE 400MG + 600MG INDIA

AMOXYCILLIN 250MG INDIA

AMOXYCILLIN 500MG INDIA

AMPICILLIN + CLOXACILLIN INDIA

ALBENDAZOLE 400MG INDIA

AMOXICILLIN 125MG/5ML INDIA

TERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE + GUAIFENESIN

2.5MG + 8MG + 100MG

MEDREICH LTD (UNIT III) -SURVEY 4/3 AVALAHALI ANJANAPURA POST OFF KARNAKATA BANGALORE 560 062

MEDREICH LTD-4/3 OFF KANAPURA ROAD, AVALAHALLI, A,

MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIA

MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIA

MEDREICH STERILAB LIMITED-NO. 4/3, AVALAHALI ANJANAPURA POST,OFF KANAKAPWA ROAD, BANGALORE 560062 INDIA

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

60 MG / 0.6 ML + 30 MG / 0.6 ML

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

Page 566: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN 250MG/5ML INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

AMPICILLIN/ CLOXACILLIN 250MG/5ML INDIA

INDIA

IBUPROFEN + PARACETAMOL 400MG + 325MG INDIA

KETOCONAZOLE 200MG INDIA

CO-TRIMOXAZOLE 240MG/5ML INDIA

IBUPROFEN 100MG/5ML INDIA

GINKO BILOBA EXTRACT 40MG THAILAND

CALCITRIOL 0.25MCG THAILAND

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

AMOXICILLIN + POTASSIUM CLAVULANATE

400MG/5ML + 57MG/5ML

MEDREICH STERILAB LTD-12TH MILE, OLD MADRAS ROAD, VIRGONAGOR, BANGALORE 560049, INDIA

MEDREICH STERILAB LTD-UNIT VI 54/2 BOODHIHALLI VI

MEDRIECH STERILAB LTD,BANGALORE-MEDRIECH STERILAB LTD, AVALAHALLI BANGALORE 560062

MEDRIECH STERILAB LTD.--ANALGHALLI, BANGLORE - 560062

MEDRIECH STERILAB LTD-AVALAHALLI BANGALORE-560 049, INDIA

MEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND

MEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND

Page 567: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT MULTI-INGREDIENT THAILAND

325MG+37.5MG THAILAND

ISOTRETINOIN 20MG THAILAND

ISOTRETINOIN 1OMG THAILAND

MULTI-INGREDIENT MULTI-INGREDIENT THAILAND

NATURAL VITAMIN E 400IU THAILAND

MULTI-INGREDIENT MULTI-INGREDIENT THAILAND

IBUPROFEN 400MG THAILAND

THAILAND

DICLOFENAC SODIUM 75 MG SWITZERLAND

MEGA LIFE SCIENCES LIMITED-: PLANT I : 384 SOI 6, PATTANA 3 ROAD, BANGPOO INDUSTRIAL ESTATE, SAMUTPRAKAN 10280, THAILAND

PARACETAMOL+TRAMADOL HYDROCHLORIDE

MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED..-515/1 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG

MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280

MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280

MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280

MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280

MEGA LIFE SCIENCES PUBLIC COMPANY LIMITED-384 SOIB PATTANA 3 RD BANGPOO INDUSTRIAL ESTATE SAMUTPRAKARN 10280

MEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN

FERROUS FUMERATE+FOLIC ACID+VITAMIN B12

162MG +0.75MG +7.5MCG

MEGA LIFESCIENCES LTD.-384 PATTANA 3 ROAD BANGPOO INDUSTRIAL ESTATE SUMUTPRAKAN

MEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASEL

Page 568: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTESUNATE + MEFLOQUINE 200 MG + 250 MG SWITZERLAND

ARTESUNATE + MEFLOQUINE 300 MG + 375 MG SWITZERLAND

250I.U + 5000I.U AUSTRIA

LEVOTHYROXINE SODIUM 25 MCG GERMANY

BISOPROLOL HEMIFUMARATE 5MG GERMANY

BISOPROLOL HEMIFUMARATE 10MG GERMANY

METFORMIN HYDROCHLORIDE 500MG GERMANY

METFORMIN HYDROCHLORIDE 1000MG GERMANY

LEVOTHYROXINE 100MCG

LEVOTHYROXINE SODIUM 50MCG GERMANY

MEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASEL

MEPHA LTD,-DORNACHESTRASSE 114 CH-4147, AESCH, BASEL

BACITRACIN ZINC+NEOMYCIN SULPHATE

MERCK KGAA & CO.-HOSSLGASSE 20 9800 SPITTAL DRAU/ AUSTRIA

MERCK KGAA- GERMANY-250 FRANKFURTERSTRASSE, 64293 DARMSTADT, GERMANY

MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT

MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT

MERCK KGAA--FRANKFURTER STR. 25064293 DARMSTADTGERMANY,MERCK SANTÉ S.A.S.-2 RUE DU PRESSOIR VERT45400 SEMOYFRANCEMERCK KGAA--FRANKFURTER STR. 25064293 DARMSTADTGERMANY,MERCK SANTÉ S.A.S.-2 RUE DU PRESSOIR VERT45400 SEMOYFRANCEMERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY

SOUTH AFRICA

MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY

Page 569: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

5 MG + 6.25 MG GERMANY

10 MG + 6.25 MG GERMANY

2.5 MG + 6.25 MG GERMANY

METFORMIN 1000MG FRANCE

METFORMIN + GLIBENCLAMIDE 500MG + 2.5MG FRANCE

METFORMIN + GLIBENCLAMIDE 500MG + 5MG FRANCE

METFORMIN HYDROCHLORIDE 750MG FRANCE

METFORMIN 500MG FRANCE

FOLLITROPIN ALFA 22 µG/0,5 ML SWITZERLAND

FOLLITROPIN ALFA 33µG/ 0.7ML SWITZERLAND

BISOPROLOL + HYDROCHLOROTHIAZIDE

MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY

BISOPROLOL + HYDROCHLOROTHIAZIDE

MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY

BISOPROLOL + HYDROCHLOROTHIAZIDE

MERCK KGAA-FRANKFURTER STRASSE 250 64271 DARMSTADT GERMANY

MERCK SANTE S A S,2RUE DU PRESSOIR VERT,SEMOY & MERCK PHARMACEUTICAL MANUFACTURING PVT LTD-259 DAVIDSON ROAD,WADEVILLE,GERMISTON

MERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY

MERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY

MERCK SANTE S.A.S-CENTRE DE PRODUCTION DE SEMOY 2 RUE DU PRESSIOR VERT 45400 SEMOY,MERCK KGAA-250 FRANKFRUTER STRASSE 250-64293 DARMSTADT

MERCK SANTÉ-2, RUE DU PRESSOIR VERT F 45400, SEMOY,NKUNZI PHARMACEUTICALS (PTY) LTD.-259 DAVIDSON ROAD CNR PEDDIE STREET, WADEVILLE EST. 1 GERMISTON 1422

MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND

MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND

Page 570: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FOLLITROPIN ALFA/LUTROPIN ALFA 150 I.U/75 I.U SWITZERLAND

FOLLITROPIN ALFA 66MCG/1.5ML SWITZERLAND

FOLLITROPIN ALFA 75IU/IE SWITZERLAND

CHORIOGONADOTROPIN ALFA 250MCG/0.5ML SWITZERLAND

ITALY

INDINAVIR SULPHATE 400MG

DICLOFENAC SODIUM 75MG/2ML GERMANY

XYLOMETAZOLINE 0.1 % W/V GERMANY

TRAMADOL 50MG GERMANY

TRAMADOL 100MG/2ML GERMANY

MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND

MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND

MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY,MERCK SERONO S.A. (MSA) -1170 SUCCURSALE D’AUBONNE ZONE INDUSTRIELLE DE L’OURIETTAZ, SWITZERLAND

MERCK SERONO SA-1170 AUBONNE(SWITZERLAND),MERCK SERONO S.P.A-VIA DELLE MAGNOLIE,15.70026 MODUGNO (BA).ITALY

EFAVIRENZ+EMTRICITABINE + TENOFOVIR

600MG +200MG+300MG

MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEM

MERCK SHARP & DOHME B.V-WAARDENWEG 392031 BN, HAARLEM

NETHERLANDS

MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN

MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN

MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN

MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN

Page 571: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

XYLOMETAZOLINE 0.05%W/V GERMANY

DICLOFENAC SODIUM 1%W/W GERMANY

INDIA

INDOMETHACIN 100 MG INDIA

DICLOFENAC SODIUM 100MG INDIA

METRONIDAZOLE 500MG INDIA

ACETAMINOPHEN 250MG INDIA

MULTINGREDIENT MULTINGREDIENT INDIA

MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN

MERCKLE GMBH,-LUDWIG MERCKLE STRASSE3 D-89143 BLAUBEUREN

HYDROCORTISONE ACETATE +LIDOCAINE +ZINC OXIDE +ALLANTOIN

0.25%W/W+3%W/W+5%W/W+0.5%W/W

MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI GUJARAT,INDIA

MERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA

MERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA

MERIDIAN ENTERPRISES PVT. LTD--PLOT NO. 418, G.I.D.C.,KABILPORE, NAVSARI 396424 GUJARAT,INDIA

MERIDIAN ENTERPRISES PVT. LTD-PLOT NO. 418, G.I.D.C.,KABILPORE,NAVSARI 396424 GUJARAT,INDIA

ROTAVIRUS LIVE REASSORTANT VIRUS G1+G2+G3+G4 &P1

2.2M IU+2.8M IU+2.2M IU+2.0M IU

MERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA

UNITED STATES

QUADRIVALENT HUMAN PAPILLOMAVIRUS RECOMBINANT VACCINE (TYPES 6, 11, 16, 18)

20MCG/40MCG/40MCG/20MCG/0.5ML

MERK & CO. INC-SUMNEYTOWN PIKE, P.O BOX 4, WEST POINT, PENNSYLVANIA, U.S. 19486, USA

UNITED STATES

META HERBALS PVT LTD-G-523, G.I.D.C, LODHIKA, VILLAGE METODA, KALAWAD ROAD, DISTRICT RAJKOT, INDIA

Page 572: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN + CLAVULANATE 875 MG + 125 MG INDIA

AMOXICILLIN + CLAVULANIC ACID INDIA

500 MG + 125 MG INDIA

AMOXICILLIN + CLAVULANIC ACID 500MG+125MG INDIA

CEFIXIME 100MG INDIA

CEFEPIME HYDROCHLORIDE 1G INDIA

CEFIXIME 50MG/5ML INDIA

CEFIXIME 200MG INDIA

200MG + 125MG INDIA

INDIA

MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA

250 MG + 62.5 MG/5 ML

MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA

AMOXYCILLIN + CLAVULANATE POTASSIUM

MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA

MICRO LABS LIMITED -PLOT 16 VEERASANDRA IND. AREA,ANEKAL TALUK,BANGALORE INDIA

MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

CEFIXIME TRIHYDRATE + CLAVULANIC ACID

MICRO LABS LIMITED, BOMMASANDRA -PLOT NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

AMOXICILLIN + CLAVULANATE POTASSIUM

200MG + 28.5MG/ 5ML

MICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA

Page 573: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

250MG + 125MG INDIA

INDIA

PRAZIQUANTEL USP 600MG INDIA

TELMISARTAN 40MG INDIA

0.5%W/V INDIA

2MG+15MG+500MG INDIA

AMITRIPYTLINE 25MG INDIA

GLIMEPIRIDE + METFORMIN 1MG + 500MG INDIA

ITRACONAZOLE 100MG INDIA

CLOPIDOGREL 75MG INDIA

AMOXICILLIN +CLAVULANATE POTASSIUM

MICRO LABS LIMITED.-PLOT 16, VEERASANDRA IND. AREA,ANEKAL TALUK, BANGALORE INDIA

LOSARTAN POTASSIUM + AMLODIPINE BESILATE + HYDROCHLOROTHIAZIDE

50MG + 5MG + 12.5MG

MICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU

MICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU

MICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU

SODIUM CARBOXYMETHYL CELLULOSE

MICRO LABS LTD ..-57, SIPCOT INDUSTRIAL COMPLEX, HOSUR-635126, TAMIIL NADU

GLIMEPIRIDE + PIOGLITAZONE+ METFORMIN

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

Page 574: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

5MG + 5MG INDIA

OLMESARTAN MEDOXOMIL 40MG INDIA

NEBIVOLOL HYDROCHLORIDE 10MG INDIA

NEBIVOLOL HYDROCHLORIDE 2.5 MG INDIA

ATORVASTATIN 20MG INDIA

PRAZIQUANTEL 600MG INDIA

ACECLOFENAC 200MG INDIA

ACECLOFENAC + PARACETAMOL 100 MG + 500 MG INDIA

EBASTINE 20MG INDIA

5MG + 12.5MG INDIA

NEBIVOLOL HYDROCHLORIDE + AMLODIPINE BESILATE

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD 92 SIPCOT -92 SIPCOT HOSUR 635 126 TAMIL NADU

MICRO LABS LTD --PLOT NO. S-155 TO S-159 VERNA INDUSTRIAL ESTATE III VERNA GOA 403722

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

NEBIVOLOL + HYDROCHLOROTHIAZIDE

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

Page 575: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NEBIVOLOL HCL 5MG INDIA

ORNIDAZOLE + OFLOXACIN 500MG + 200MG INDIA

TELMISARTAN 80MG INDIA

40MG/12.5MG INDIA

50MG + 12.5MG INDIA

EBASTINE 10 MG INDIA

CO-TRIMOXAZOLE 960MG INDIA

GLIMEPIRIDE 2MG INDIA

OFLOXACIN 200MG INDIA

AMLODIPINE 5MG INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

TELMISARTAN/HYDROCHLOROTHIAZIDE

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

Page 576: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LOSARTAN POTASSIUM 50MG INDIA

LEVOFLOXACIN HEMIHYDRATE 750MG INDIA

ATORVASTATIN 10MG INDIA

PARACETAMOL 500MG INDIA

50MG + 5MG INDIA

ACECLOFENAC 100MG INDIA

COTRIMOXAZOLE 960MG INDIA

FEXOFENADINE HYDROCHLORIDE 180 MG INDIA

FEXOFENADINE HYDROCHLORIDE 120MG INDIA

GLIMEPIRIDE+ METFORMIN 1MG + 500MG INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

MICRO LABS LTD-92, SIPCOT INDUSTRIAL COMPLEX HOSU R-635126 (T.N) INDIA

LOSARTAN POTASSIUM / AMLODIPINE

MICRO LABS LTD-92,SIPCOT INDUSTRIAL COMPLEX,HOSUR-635-126(T.N)INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

Page 577: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MOXIFLOXACIN 400MG INDIA

OLMESARTAN MEDOXOMIL 20 MG INDIA

PANTOPRAZOLE 40MG INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

CO-TRIMOXAZOLE 100MG/200 MG INDIA

GLIMEPIRIDE 4MG INDIA

AZITHROMYCIN 500MG INDIA

METFORMIN HYDROCHLORIDE 1000MG INDIA

TORSEMIDE 20MG INDIA

CEFUROXIME 1500MG INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO 92, SIPCOT, HOSUR-635 126,, TAMIL NADU, INDIA

MICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

Page 578: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFUROXIME AXETIL USP 500MG INDIA

CEFIXIME 400MG INDIA

CEPHALEXIN 250MG INDIA

AMOXICILLIN TRIHYDRATE 250MG INDIA

AMOXYCILLIN TRIHYDRATE 125MG/5ML INDIA

AMPICILLIN TRIHYDRATE 125MG/5ML INDIA

AMOXICILLIN TRIHYDRATE 250MG INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

500MG/50MG INDIA

MICRO LABS LTD--NO. 121-124 4TH PHASE K.I.A.D.B BOMMASANDRA INDUSTRIAL AREA ANEKAL TALUK BANGALORE 560 099

MICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA

MICROLABS LIMITED-PLOT NO. 121-124, KIADB, BOMMASANDRA , -JIGNI LINK ROAD, ANEKUL TALUK,BANGALORE, KARNATAKA, INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO 63/67/87 J.C.I.E LTD KAMOTHE PANVER, NAVI MUMBAI,INDIA,BAROQUE PHARMACEUTICALS PVT LTD --S.NO.192/2 & S.NO.192/2 &3 SOKHADA-388 620 KHAMBHAT. DIST. ANAND GUJARAT INDIAMILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA

PARACETAMOL/DICLOFENAC SODIUM

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA

Page 579: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMPICILLIN/ CLOXACILLIN 250MG/5ML INDIA

125MG/ML INDIA

AMPICILLIN TRIHYDRATE 250MG INDIA

AMOXICILLIN 125MG INDIA

250MG INDIA

CLOXACILLIN 125MG/5ML INDIA

AMPICILLIN 250MG INDIA

AMOXYCILLIN 250MG INDIA

AMPICILLIN 125MG/5ML INDIA

AMOXYCILLIN 125MG/5ML INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA

PHENOXYMETHYL PENICILLIN SODIUM

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA

MILAN LABORATORIES (INDIA ) PVT LTD-PLOT NO.63-67 & 87,JAWAHAR CO.OP.INDUSTRIAL ESTATE LTD KAMOTHE,PANVEL DIST. THANE,MAHARASTRA-410209,INDIA

MILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)

PHENOXYMETHYL PENICILLIN POTASSIUM

MILAN LABORATORIES (INDIA) PVT LTD .-PLOTS 63,67,87,35,36,64,65, JAWAHAR CO-OP IND. ESTATE LTD, KAMOTHE, PANVEL (NAVI MUMBAI)

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

Page 580: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CO-TRIMOXAZOLE 480MG INDIA

DICLOFENAC 1%W/W INDIA

CLOTRIMAZOLE 1%W/W INDIA

CLOXACILLIN 250MG INDIA

INDIA

AMOXICILLIN TRIHYDRATE 250 MG INDIA

DICLOFENAC POTASSIUM 50MG ITALY

30+70 I.U INDIA

2.6MG INDIA

120MG INDIA

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

MILAN LABORATORIES -PLOT NOS 63, 67 & 87, JAWAHAR CO-OP. INDUSTRIAL ESTATE LTD., KAMOTHE, PANVEL (NAVI MUMBAI).

ALUMINUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE

3.75 G/ 200 ML + 2.724 G/ 200 ML + 0.399 G/ 200 ML

MILAN LABS PVT LTD-63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAI

MILAN LABS PVT LTD-63-67 JAWAHAR CO.OP. INDUSTRIAL ESTATE KAMOTHE,NAVI MUMBAI

MIPHARM S.P.A -VIA BERNARDO QUARANTA, 12-20141, MILANO ITALY.

INSULIN SOLUBLE+INSULIN ISOPHANE

MJ BIOPHARM PRT LTD-L-7 MIDC INDUSTRIAL AREA, TALOJA, NARI MUMBAI MAHARASHTRA

NITROGLYCERIN (CONTROLLED RELEASE)

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

Page 581: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

90MG INDIA

INDIA

THEOPHYLLINE 600MG INDIA

TRAMADOL HYDROCHROLIDE 100MG INDIA

THEOPHYLLINE 400MG INDIA

NITROGLYCERIN 6.4MG INDIA

500MG INDIA

SODIUM VALPROATE 200 MG INDIA

TAMSULOSIN HYDROCHLORIDE 0.4MG INDIA

INDAPAMIDE 1.5MG INDIA

CONTROLLED RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

FERROUS GLYCINE SULPHATE+ZINC SULPHATE+FOLIC ACID

100MG+61.8MG+0.5MG

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

MODI MUNDIPHARMA (PVT) LTD-MEERUT - MUZAFFARNAGAR ROAD, MODIPURAM, UTTAR PRADESH ESTATE

SODIUM VALPROATE (CONTROLLED RELEASE)

MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH

MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH

MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH

MODI MUNDIPHARMA PVT. LTD-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM – 250110 UTTAR PRADESH

Page 582: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ARTEMETHER + LUMEFANTRINE 360MG + 2160MG

SITAGLIPTIN 25MG

SITAGLIPTIN 100MG

SITAGLIPTIN 50MG

0.05%W/V BELGIUM

ATORVASTATIN 20MG INDIA

ROSUVASTATIN CALCIUM 5MG INDIA

ROSUVASTATIN CALCIUM 20MG INDIA

MONTELUKAST SODIUM 10MG INDIA

MONTELUKAST SODIUM 4MG INDIA

MPF BV-APPLEHOF 13; NI 8465 RX OUDEHASKENETHERLANDS

NETHERLANDS

MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685

SOUTH AFRICA

MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685

SOUTH AFRICA

MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685

SOUTH AFRICA

MOMETASONE FUROATE MONOHYDRATE

MSD PTY LTD-117 16TH ROAD, HALFWAY HOUSE 1685,SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM

MSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE

MSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE

MSN LABORATORIES LTD- PLOT N0.42, ANRICH INDUSTRIAL ESTATE

MSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH

MSN LABORATORIES LTD -PLOT NO. 42 INDUSTRIAL ESTARE BOLLARAM MEDAK DISTRIC 502325 ANDHRA PRADESH

Page 583: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACECLOFENAC + PARACETAMOL 100 MG + 500 MG INDIA

ATORVASTATIN 10MG INDIA

FEBUXOSTAT 80MG INDIA

FEBUXOSTAT 40MG INDIA

2MG+500 MG INDIA

LEVOFLOXACIN 500MG INDIA

LEVOFLOXACIN 750MG INDIA

MONTELUKAST SODIUM 5MG INDIA

MONTELUKAST SODIUM 10MG INDIA

MONTELUKAST SODIUM 5MG INDIA

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

GLIMEPIRIDE+METFORMIN HYDROCHLORIDE

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

Page 584: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MONTELUKAST SODIUM 4MG INDIA

MOXIFLOXACIN HYDROCHLORIDE 400MG INDIA

PRASUGREL 10MG INDIA

PREGABALIN 150MG INDIA

PREGABALIN 75MG INDIA

SILDENAFIL CITRATE 100MG INDIA

SILDENAFIL CITRATE 50MG INDIA

TELMISARTAN 40MG INDIA

TELMISARTAN 80MG INDIA

TELMISARTAN 80MG INDIA

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

Page 585: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TELMISARTAN 40MG INDIA

PRASUGREL 5MG INDIA

PREGABALIN 75MG INDIA

LEVOFLOXACIN 500MG INDIA

ROSUVASTATIN 10MG INDIA

PREGABALIN 150MG INDIA

MONTELUKAST 5MG INDIA

MONTELUKAST 5MG INDIA

POVIDONE IODINE 1%W/V CYPRUS

POVIDONE IODINE 10%W/V CYPRUS

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT 42 ANRICH INDUSTRIAL ESTATE BOLLARAM MEDAK DISTRICT 502325 ANDHRA PRADESH

MSN LABORATORIES LTD-PLOT NO.42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, INDIA

MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICTPIN CODE 502 325ANDHRA PRADESH, INDIA.

MSN LABORATORIES PVT. LIMITED-PLOT NO. 42 ANRICH INDUSTRIAL ESTATE, BOLLARAM MEDAK DISTRICTPIN CODE 502 325ANDHRA PRADESH, INDIA.

MUNDIPHARMA PHARMACEUTICALS -13 OTHELLOS STREET, DHALI INDUSTRIAL ZONE, NICOSIA

MUNDIPHARMA PHARMACEUTICALS -13 OTHELLOS STREET, DHALI INDUSTRIAL ZONE, NICOSIA

Page 586: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

POVIDONE IODINE 7.5%W/V CYPRUS

POVIDONE IODINE USP 10% W/W CYPRUS

POVIDONE IODINE 10%W/W CYPRUS

PIPERACILLIN + TAZOBACTAM 4+0.5 G/VIAL INDIA

FLUCONAZOLE 200 MG INDIA

LEVONORGESTREL 750MCG INDIA

LEVONORGESTREL 1.5MG INDIA

INDIA

MUNDIPHARMA PHARMACEUTICALS -13 OTHELLOS STREET, DHALI INDUSTRIAL ZONE, NICOSIA

MUNDIPHARMA PHARMACEUTICALS -13 OTHELLOS STREET, DHALI INDUSTRIAL ZONE, NICOSIA

MUNDIPHARMA PHARMACEUTICALS -13 OTHELLOS STREET, DHALI INDUSTRIAL ZONE, NICOSIA

MYLAN LABORATORIES LIMITED(BETA LACTAM DIVISION)-NO. 152/6, 154/16 DORESANIPALYA, BILEKAHALLI, BANNERGHATTA ROAD BANGALORE - 560 076 INDIA

MYLAN LABORATORIES LIMITED, √-PLOT NO. H-12 & H-13, MIDC, WALUJ INDUSTRIAL AREA AURANGABBAD- 431136 MAHARASTRA STATE, INDIA.

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

LEVONORGESTREL & ETHINYLESTRADIOL + FERROUS FUMARATE

150MCG + 30MCG + 75MG

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

Page 587: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

150MCG + 30MCG INDIA

INDIA

LEVONORGESTREL 0.03MG INDIA

INDIA

LEVONORGESTREL 0.75MG INDIA

ACYCLOVIR 200MG INDIA

LEVONORGESTREL + ETHINYLESTRADIOL

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

NORGESTREL/ ETHINYL ESTRADIOL + FERROUS FUMARATE

0.3MG/ 0.03MG + 75MG

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

LEVONORGESTREL & ETHINYLESTRADIOL+ FERROUS FUMARATE

0.15MG + 0.03MG + 75MG

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

MYLAN LABORATORIES LIMITED.--PLOT NO. 1606-1609, SARIGAM INDUSTRIAL AREA, GIDC, SARIGAM, TAL-UMERGAM, DIST VALSAD, 396155, GUJARAT, INDIA.,MYLAN LABORATORIES LIMITED..-PLOT NO.20 & 21, PHARMEZ, SARKHEJ-BAVLA NATIONAL HIGHWAY NO. 08A, NEAR VILLAGE MATODA, TAL-SANAND, AHMEDABAD, GUJARAT, INDIA 382213

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

Page 588: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACICLOVIR 400MG INDIA

ISONIAZID 300MG INDIA

INDIA

ZIDOVUDINE 300MG INDIA

ZINC SULFATE 20MG INDIA

FLUCONAZOLE 50MG INDIA

EMTRICITABINE/TENOFOVIR 200MG/300MG INDIA

ABACAVIR SULFATE + LAMIVUDINE 60MG + 30MG INDIA

SOFOSBUVIR 400MG INDIA

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

ABACAVIR SULFATE + LAMIVUDINE + ZIDOVUDINE

300 MG + 150 MG + 300 MG

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.

MYLAN LABORATORIES LIMITED.-PLOT NO. H-12 & H-13 MIDC, WALUJ INDUSTRIAL AREA,AURANGABAD. – 431136, MAHARASHTRA STATE, INDIA.,MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATEMYLAN LABORATORIES LIMITEDD ,-F-4 & F-12,MIDC,MALEGAON,SIRRRRAR, NASHIK -422113MAHARASHTRA, INDIA.

MYLAN LABORATORIES LIMITEDD ,-F-4 & F-12,MIDC,MALEGAON,SIRRRRAR, NASHIK -422113MAHARASHTRA, INDIA.

Page 589: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OSELTAMIVIR PHOSPHATE 75MG INDIA

OSELTAMIVIR PHOSPHATE 30MG INDIA

OSELTAMIVIR PHOSPHATE 45MG INDIA

ARTEMETHER + LUMEFANTRINE 40 MG + 240 MG INDIA

ARTEMETHER + LUMEFANTRINE 20 MG+ 120 MG INDIA

ABACAVIR SULFATE + LAMIVUDINE 600 MG + 300 MG INDIA

ABACAVIR SULFATE 300MG INDIA

RITONAVIR 100MG INDIA

INDIA

LOPINAVIR + RITONAVIR 200MG + 50MG INDIA

MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA

MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA

MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

30MG + 50MG + 60MG

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

Page 590: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LAMIVUDINE 150MG INDIA

TENOFOVIR DISOPROXIL FUMARATE 300MG INDIA

ATAZANAVIR + RITONAVIR 300 MG + 100 MG INDIA

LOPINAVIR / RITONAVIR 100MG / 25MG INDIA

LAMIVUDINE + ZIDOVUDINE 30MG + 60MG INDIA

EFAVIRENZ 600MG INDIA

300MG+300MG INDIA

INDIA

INDIA

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA

TENOFOVIR DISOPROXIL FUMARATE + LAMIVUDINE

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA

TENOFOVIR DISOPROXIL + LAMIVUDINE + EFAVIRENZ

300MG/300MG/600MG

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA,MYLAN LABORATORIES LIMITED .-PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE

TENOFOVIR DF + EMTRICITABINE + EFAVIRENZ

300MG+200MG+600MG

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD -- PLOT NO. H-12 & H-13 MIDCWALUJ INDUSTRIAL AREA AURANGABAD 431136 MAHARASTRA,MYLAN LABORATORIES LIMITED -PLOT NO. 11,12&13 INDORE SPECIAL ECONOMIC ZONE

Page 591: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NEVIRAPINE 200MG INDIA

LAMIVUDINE + ZIDOVUDINE 150MG + 300MG INDIA

INDIA

ETONOGESTREL 68MG

DESOGESTREL/ETHINYLESTRADIOL 150MG/30MG

20MG + 1MG/G PAKISTAN

SECNIDAZOLE 1000MG PAKISTAN

DINOPROSTONE 3MG PAKISTAN

19.2G+7.2G/ 120ML PAKISTAN

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

150MG + 200MG + 300MG

MYLAN LABORATORIES LTD--F-4,F-12 MALEGAON MIDC SINNAR NASHIK 422113 MAHARASHTRA STATE,MYLAN LABORATORIES LTD --H-12 & H-13, MIDC, WALUJ,AURANGABAD- 431136 MAHARASHTRA, INDIA

N.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND

NETHERLANDS

N.V. ORGANON-KLOOSTERSTRAAT 6, 5349 AB OSS, THE NETHERLAND

NETHERLANDS

FUSIDIC ACID + BETAMETHASONE VALERATE

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

DISODIUM BISPHOSPHATE/ SODIUM PHOSPHATE

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

Page 592: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LORATADINE 10MG PAKISTAN

LORATADINE 5MG/5ML PAKISTAN

45MG +8MG PAKISTAN

CLINDAMYCIN PHOSPHATE 2%W/W PAKISTAN

DINOPROSTONE 0.5MG PAKISTAN

AZITHROMYCIN 250MG PAKISTAN

AZITHROMYCIN 200MG/5ML PAKISTAN

PAKISTAN

SULPHANILAMIDE 15%W/W PAKISTAN

TETRACYCLINE HYDROCHLORIDE 3%W/W CHINA

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

ACEFYLINE PIPERAZINE + DIPHENHYDRAMINE HYDROCHLORIDE

NABIQASIM INDUSTRIES (PVT) LIMITED-17/24, KORANGI INDUSTRIAL AREA, KARACHI, PAKISTAN

NABIQASIM INDUSTRIES (PVT) LTD√-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.

NABIQASIM INDUSTRIES (PVT) LTD√-17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.

NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.

NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.

FERRIC AMMONIUM CITRATE +FOLIC ACID + PYRIDOXINE HCL + THIAMINE HCL + NICOTINAMIDE

50MG + 0.5MG + 2.2MG + 1.3MG +11MG

NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.

NABIQASIM INDUSTRIES (PVT) LTD--17/24,KORANGI INDUSTRIAL AREA, KORANGI, KARACHI- PAKISTAN.

NANJING BAIJINGYN PHARMACEUTICALS CO.LTD NO-1 HUIZHONG ROAD NANJING ECONOMIC AND TECHNICAL DEVELOPMENT ZONE

Page 593: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CISPLATIN 1MG/ML INDIA

DACARBAZINE FOR INJECTION USP 200MG INDIA

DOCETAXEL 40MG/ML INDIA

ETOPOSIDE INJECTION USP 100MG INDIA

L-ASPARGINASE 1000 I.U INDIA

PACLITAXEL 6MG/ML INDIA

CYTARABINE 100MG/5ML INDIA

DOXORUBICIN HCL 100MG INDIA

CHLORAMBUCIL 2MG INDIA

DOXORUBICIN 50MG INDIA

NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA.

NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA.

NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA.

NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA.

NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA.

NAPROD LIFE SCIENCE PVT LTD-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA.

NAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA

NAPROD LIFE SCIENCES (PVT) LIMITED-PLOT G-17/1 MIDC TARAPUR BOISAR, DIST. THANE-401506 MAHARASTRA, INDIA

NAPROD LIFE SCIENCES PVT LTD-G17 MDC TARAPUR IND AREA THONE, MUMBAI INDIA

NAPROD LIFE SCIENCES PVT LTD-G17 MDC TARAPUR IND AREA THONE, MUMBAI INDIA

Page 594: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GEMCITABINE 1G INDIA

GEMCITABINE 200MG INDIA

GEMCITABINE 200MG INDIA

VINCRISTINE SULPHATE 1MG INDIA

KETAMINE HYDROCHLORIDE 50MG/ML NEPAL

TRAMADOL HYDROCHLORIDE 50MG NEPAL

CEFTRIAXONE SODIUM 1 GM INDIA

RANITIDINE HYDROCHLORIDE 25MG/ML INDIA

CHLORAMPHENICOL 0.5% W/V INDIA

GERMANY

NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI

NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI

NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI

NAPROD LIFE SCIENCES PVT LTD-G-17, MIDC, TARAPUR INDUSTRIAL AREA, BIOSAR THANE, MUMBAI

NATIONAL HEALTHCARE PVT LTD-CHHATAPIPRA 3 BARA NEPAL

NATIONAL HEALTHCARE PVT. LTD.-(WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPAL

NATIONAL HEALTHCARE PVT. LTD.-(WORKS: STERILE BLOCK) CHHATAPIPRA-3, BARA, NEPAL

NATIONAL HEALTHCARE PVT. LTD.--WORKS: STERILE BLOCK CHHATAPIPRA-3, BARA, NEPAL

NATIONAL HEALTHCARE PVT. LTD.--WORKS: STERILE BLOCK CHHATAPIPRA-3, BARA, NEPAL

ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE

175MG + 200MG + 25MG/ 5ML

NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANY

Page 595: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GERMANY

CEFUROXIME AXETIL 250MG INDIA

CEFIXIME 200MG INDIA

CEFUROXIME 500MG INDIA

CEFUROXIME 750MG INDIA

CEFEPIME 1000MG INDIA

CEFIXIME 100MG INDIA

CEFPODOXIME PROXETIL 200MG INDIA

CEFTRIAXONE 1G INDIA

INDIA

ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE

175MG + 200MG/ 5ML

NATTERMAN & CIE , GMBH NATTERMANNALLEE 1 -,50829 COLOGNE , GERMANY

NECTAR LIFE SCIENCES LTD--UNIT VI BHATOLIKALAN DIST SOLAN H.P

NECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA

NECTAR LIFE SCIENCES LTD-VILL. BHATOLIKALAN, ADJOINING JHARMJRI, E.P.I.P TEL.NALAGARH, DISTT. SOLAN, H.P.-173205 INDIA

NECTAR LIFESCIENCES LIMITED-VILL. BHATOLIKALAN, ADJOININGJHARMJRI,P.O BAROTIWALA DIST SOLAN H.P 173205

NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205

NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205

NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205

NECTAR LIFESCIENCES LTD UNIT VI-BHATOLIKALAN P.O BAROTIWALA DISTT SOLAN HIMACHAL PRADESH 173205

DIACERIN + METHYL SULPHONYL METHANE + GLUCOSAMINE SULPHATE

50MG +250MG + 750MG

NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE – 401 210, MAHARASHTRA – INDIA

Page 596: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

FUROSEMIDE 40MG INDIA

INDIA

TETRACYCLINE 1%W/W INDIA

AMINOPHYLLINE 100MG INDIA

PREDNISOLONE 5MG INDIA

50MG+500MG INDIA

CHLORAMPHENICOL 1%W/W INDIA

DIAZEPAM 5MG INDIA

METHYLDOPA 250MG INDIA

DICLOFENAC/METHYL SALICYLATE/MENTHOL/CAPSICUM OLEORESIN

10MG/80MG/60MG/0.15MG

NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE – 401 210, MAHARASHTRA – INDIA

NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE – 401 210, MAHARASHTRA – INDIA

MENTHOL + CAMPHOR + PEPPERMINT OIL + EUCALYPTUS OIL + CLOVE OIL+ CINNAMON +WINTER GREEN OIL

140MG + 140MG + 80MG +80MG +40MG +40MG +120MG

NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE – 401 210, MAHARASHTRA – INDIA

NEM LABORATORIES LIMITED-133 KRISHNA IND. ESTATE, VASAI (E),THANE – 401 210, MAHARASHTRA – INDIA

NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA

NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA

DICLOFENAC SODIUM + PARACETAMOL

NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA

NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA

NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA

NEM LABORATORIES PVT LTD-133 KRISHNA INDUSTRIAL ESTATE VASAI (E) DIST THANE 401 210 MAHARASHTRA

Page 597: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BISACODYL 5MG INDIA

COMPOUND METHYLSALICYLATE MULTI INGREDIENT INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

MULTI-INGREDIENT N/A INDIA

1MG+5MG INDIA

MULTI-INGREDIENT N/A INDIA

HYDROCORTISONE 0.1%W/W INDIA

SILVER SULFADIAZINE 1%W/W INDIA

DICLOFENAC DIETHYLAMMONIUM 1%W/W INDIA

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

BETAMETHASONE+NEOMYCIN SULPHATE

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

Page 598: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

BENZOIC ACID + SALICYLIC ACID 0.06G+0.03G INDIA

INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

CLOTRIMAZOLE 1%W/W INDIA

SULPHUR 10%W/W INDIA

MULTIVITAMIN MULTI-INGREDIENT INDIA

DIGOXIN 0.25MG INDIA

1G/VIAL INDIA

HYOSCINE BUTYLBROMIDE 20MG/ML INDIA

METHYLSALICYLATE+CAPSICUM OLEORESIN+TUPENTINE OIL

15%W/W + 1%W/W + 1.47%W/W

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

BETAMETHASONE + CHLOROCRESOL + GENTAMICIN + CLIOQUINOL + TOLNAFTATE

0.05% W/W + 0.1% W/W + 0.1% W/W + 1% W/W + 1% W/W

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD---133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT LTD-NEM LABORATORIES PVT LTD, 133 VASAI RD(E) 401 162 SB MARG. LOWER PAREL MUMBAI

NEM LABORATORIES PVT. LIMITED-133 KRISHNA IND. ESTATE, VASAI (E), THANE – 401 210, MAHARASHTRA - INDIA

CHLORAMPHENICOL SODIUM SUCCINATE

NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA

NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA

Page 599: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PROPOFOL 1%W/V INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

BUPIVACAINE 50MG/20ML INDIA

CEFTRIAXONE 1G INDIA

CISPLATIN 10MG/10ML INDIA

LETROZOLE 2.5MG INDIA

LIDOCAINE 2% W/V INDIA

OXYTOCIN 10 I.U./ ML INDIA

2MG/2ML INDIA

THIOPENTAL SODIUM 500MG INDIA

NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA

NEON LABORATORIES LTD --PLOT NO. 29, 30, 31, 32, 57 & 60, THE PALGHAR TALUKA - CO-OP ESTATE LTD., BOISAR ROAD, PALGHAR, DIST - THANE - 401404, MAHARASHTRA

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

STERILE NORADRENALINE CONCENTRATE

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

Page 600: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BUPIVACAINE 0.025%W/V INDIA

CEFOTAXIME 1 G INDIA

8MG/2ML CHINA

OXYTOCIN 10I.U/ML CHINA

EPINEPHRINE HCL 1MG/ML CHINA

CHLORPROMAZINE 25MG/ML CHINA

INDOMETHACIN 25MG CHINA

GENTAMYCIN 0.3%W/V CHINA

LIDOCAINE 2%W/V CHINA

HYOSCINE 20MG/ML CHINA

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

NEON LABORATORIES LTD-PLOT NO. 29-32, 57 & 60, PALGHAR TALUKA CO-OPERATIVE ESTATE , BOISAR ROAD

DEXAMETHASONE SODIUM PHOSPHATE

NINGBO DAHONGYING PHARMACEUTICAL CO LTD.-NO. 3986, HI-TECH PARK MINZHU ROAD, NINGBO CITY, ZHEJIANG

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO 396, MINGZHU ROAD NINGBO CITY CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANG

NINGBO DAHONGYING PHARMACEUTICAL CO LTD-NO.3986 MINZHU ROAD NINGBO CITY ZHEJIANG

Page 601: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FUROSEMIDE 10MG/ML CHINA

DICLOFENAC SODIUM 75MG/3ML CHINA

METOCLOPRAMIDE 5MG/ML CHINA

AMINOPHYLLINE 20MG CHINA

CHLORAMPHENICOL 250MG CHINA

QUININE DIHYDROCHLORIDE 600MG/2ML CHINA

GENTAMICIN SULPHATE 80MG/2ML CHINA

PROMETHAZINE HYDROCHLORIDE 25MG/ML CHINA

CHLORAMPHENICOL 0.5%W/V CHINA

VITAMIN B COMPLEX 10MG/2ML CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICAL CO.LTD-NO. 396 MINGZHU ROAD, HI-TECH PARK, NINGBO CITY ZHEJIANG PROVINCE, CHINA

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

Page 602: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

RANITIDINE 25MG/ML CHINA

ATROPINE 1MG/ML CHINA

CHLORAMPHENICAL 5%W/V CHINA

TETRACYCLINE HYDROCHLORIDE 250 MG CHINA

ARTEMETHER 80MG/ML CHINA

CALCIUM GLUCONATE 10 %W/V CHINA

ALBENDAZOLE 400MG BANGLADESH

FLUCONAZOLE 2MG/ML INDIA

KETAMINE 50MG/ML INDIA

DICLOFENAC SODIUM 75MG/3ML INDIA

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

NINGBO DAHONGYING PHARMACEUTICALS LTD- NO. 396 MIN

NINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINA

NINGBO DAHONGYING PHARMACEUTICALS-N0.396 MINZHU RD NINGBO CITY ZHEJIANG, CHINA

NIPRO JMI PHARMA LTD.-CHAUDDAGRAM, COMILLABANGLADESH

NIRMA LIMITED (HEALTHCARE DIVISION)-VILLAGE-SACHANA, TALUKA-VIRAMGAM DISTRICT- AHMEDABAD 382 150, GUJARAT, INDIA

NIRMA LIMITED (HEALTHCARE DIVISION)-VILLAGE-SACHANA, TALUKA-VIRAMGAM DISTRICT- AHMEDABAD 382 150, GUJARAT, INDIA

NITIN LIFESCIENCES LTD--RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025

Page 603: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

8MG/2ML INDIA

CEFIXIME 400MG

METFORMIN HYDROCHLORIDE 850MG FRANCE

LORATADINE 5MG/5ML TURKEY

CEFIXIME TRIHYDRATE 400MG TURKEY

DICLOFENAC SODIUM 100MG ITALY

VILDAGLIPTIN / METFORMIN 50MG/500MG GERMANY

VILDAGLIPTIN / METFORMIN 50MG / 850MG GERMANY

VILDAGLIPTIN/ METFORMIN 50MG/1000MG GERMANY

MYCOPHENOLATE SODIUM 180MG GERMANY

DEXAMETHASONE SODIUM PHOSPHATE

NITIN LIFESCIENCES LTD--RAMPUR ROAD PAONTA SAHIB DIST. SIRMOUR (H.P) 173 025

NKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA

SOUTH AFRICA

NKUNZI PHARMACEUTICALS-259 DAVIDSON ROAD, WADEVILLEGERMISTON, 1428 SOUTH AFRICA

NOBEL ILAC DUZCE-SANAYIINVE TICARET A.S SANCAKLAR 81100 DUZCE

NOBEL İLAÇ SAN. VE TIC. A.Ş.-81100SANCAKLAR, DÜZCE-TURKEY

NORVATIS FARMA SPA--VIA PROVINCIALE SCHITO, 131 1-80052, TORRE ANNUNCIATA (NA) ITALY

NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY

NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY

NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-GERMANY

NORVATIS PHARMA PRODUCTIONS GMBH, WEHR-OEFLINGER STR. 4479664 WEHR GERMANY

Page 604: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EVEROLIMUS 5MG SWITZERLAND

EVEROLIMUS 10MG SWITZERLAND

LETROZOLE 2.5MG SWITZERLAND

SWITZERLAND

ARTEMETHER + LUMEFANTRINE 80MG +480MG TURKEY

TERBINAFINE 125MG NOVARTIS BARBERA -SPAIN SPAIN

DICLOFENAC DIETHYLAMONNIUM 1%W/V SWITZERLAND

DICLOFENAC DIETHYLAMONNIUM 1%W/V SWITZERLAND

XYLOMETAZOLINE 0.1%W/V SWITZERLAND

XYLOMETAZOLINE 0.05%W/V SWITZERLAND

NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NORVATIS PHARMA STEIN AG-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

AMLODIPINE BESYLATE + VALSARTAN + HYDROCHLOROTHIAZIDE

10MG + 320MG + 25MG

NORVATIS PHARMA STEIN-SCHAFFHAUSERSTRASSE 4332 STEIN

NORVATIS SAGLIK GIDA VE TARIM URENLERI SAN, VE TIC-AC-YENISEHIR MAHALLESI IHLA VADISI SOKAK, NO.2, 34912 KURTKOY, INSTANBUL - TURKEY

NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND

NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND

NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND

NOVARTIS CONSUMER HEALTH SA-CH-1260 NYON SWTZERLAND

Page 605: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

327MG+1000MG NOVARTIS CONSUMER HEALTH-SWITZERLAND SWITZERLAND

TERBINAFINE 1%W/W NOVARTIS CONSUMER HEALTH-SWITZERLAND SWITZERLAND

TRIBENOSIDE + LIDOCAINE HCL 5%W/W + 2%W/W SWITZERLAND

SWITZERLAND

CARBAMAZEPINE 200MG ITALY

CARBAMAZEPINE 200MG ITALY

VALSARTAN 160MG SPAIN

160MG + 12.5MG SWITZERLAND

160 MG + 25MG

DICLOFENAC SODIUM 75MG ITALY

CALCIUM CARBONATE+ASCORBIC ACID

NOVARTIS CONSUMER INT. INC.-ZYMASA-CH-1260, NYON SWITZERLAND

PHENYLEPHRINE + DIMETHINDENE MALEATE

0.25% W/V + 0.025% W/V

NOVARTIS CONSUMER INT. INC.-ZYMASA-CH-1260, NYON SWITZERLAND

NOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY

NOVARTIS FARMA S.P.A.-VIA PROVINCIALE SCHITO 131, 80058 TORRE ANNUNZIATA, ITALY

NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN

VALSARTAN + HYDROCHLOROTHIAZIDE

NOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND

VALSARTAN + HYDROCHLOROTHIAZIDE

NOVARTIS PHARMA AG-SCHAFFHAUSERSTRASSE 4332 STEIN SWITZERLAND,NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY

SWITZERLAND/ITALY

NOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA

Page 606: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOMIPRAMINE 25MG ITALY

OXCARBAZEPINE 300MG ITALY

80 MG +12.5 MG

DICLOFENAC POTASSIUM 50MG ITALY

DICLOFENAC POTASSIUM 25MG ITALY

DICLOFENAC POTASSIUM 15MG/ML FRANCE

ZOLEDRONIC ACID 4MG/5ML SWITZERLAND

LETROZOLE 2.5MG SWITZERLAND

DEFERASIROX 100MG SWITZERLAND

OCTREOTIDE ACETATE 0.05MG SWITZERLAND

NOVARTIS PHARMA SPA, TORRE ANNUNZIATA ITALY-NA

NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY

VALSARTAN + HYDROCHLOROTHIAZIDE

NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

SWITZERLAND/ITALY

NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEY

NOVARTIS PHARMA SPA,-TORRE ANNUNZIATA ITALY,NOVARTIS--URUNLERI INSTABUL TURKEY

NOVARTIS PHARMA SPA-RUE DE LA CHAPELLE, HUNIGUE

NOVARTIS PHARMA STEIN AG ;-SCHAFFHAUSERSTRASSE CH 4332 STEIN-SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

Page 607: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

GLYCOPYRRONIUM BROMIDE 50MCG SWITZERLAND

110MCG+50MCG SWITZERLAND

RUXOLITINIB 15MG SWITZERLAND

RUXOLITINIB 5MG SWITZERLAND

VALSARTAN 80MG SPAIN

VALSARTAN 160MG SPAIN

RUXOLITINIB 20MG SWITZERLAND

DEFERASIROX 400MG SWITZERLAND

AMLODIPINE + VALSARTAN 5 MG + 320 MG SWITZERLAND

AMLODIPINE + VALSARTAN 5 MG + 80 MG SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

INDACATEROL MALEATE+GLYCOPYRRONIUM BROMIDE

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN

NOVARTIS PHARMA STEIN AG.-SCHAFF HAUSER STRASSE 4332, STEIN - SWITZERLAND,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN

NOVARTIS PHARMA STEIN AG-CH. 4002 STEIN, SWITZERLAND

NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE

NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE

NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA,-BARBERA DEL VALLES BARCELONA SPAIN

Page 608: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMLODIPINE + VALSARTAN 5 MG + 160 MG SWITZERLAND

AMLODIPINE + VALSARTAN 10 MG + 160 MG

SWITZERLAND

DICLOFENAC 25MG/ML SWITZERLAND

OXYTOCIN 5 I.U SWITZERLAND

150MG SWITZERLAND

SWITZERLAND

OXYTOCIN 10 I.U/ML SWITZERLAND

VILDAGLIPTIN 50MG SWITZERLAND

VILDAGLIPTIN 50MG SWITZERLAND

NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN

NOVARTIS PHARMA STEIN AG-H-4332 STEIN SCHAFFAUSERTRASSE,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN

SWITZERLAND/SPAIN

AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE

5MG+ 160MG+ 12.5MG

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.

NILOTONIB HYDROCHLORIDE MONOHYDRATE

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.

AMLODIPINE + VALSARTAN + HYDROCHLOROTHIAZIDE

10MG + 160MG +12.5MG

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS BARBERA -SPAIN

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS FARMACEUTICA SA-RONDA DE SANTA MARIA,158, E-08210 BARBERA DEL VALLES BARCELONA SPAIN

Page 609: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MYCOPHENOLATE SODIUM 360MG SWITZERLAND

MYCOPHENOLATE SODIUM 360MG SWITZERLAND

VALSARTAN 80MG SWITZERLAND

CROTAMITON 10%W/W SWITZERLAND

INSULIN ASPART 100I.U/ML DENMARK

INSULIN ASPART 100 I.U/ML DENMARK

100 I.U/ML DENMARK

INSULIN DETEMIR 100 I.U/ML DENMARK

INSULIN HUMAN 100 I.U/ML NOVO NORDISK PHARMA-NOVO ALLE DENMARK

ISOPHANE INSULIN (HUMAN) 100 I.U/ML NOVO NORDISK PHARMA-NOVO ALLE DENMARK

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS PHARMA PRODUKTIONS GMBH-OEFLINGER STR.4479664 WEHR GERMANY

NOVARTIS PHARMA STEIN AG-SCHAFFHARVSERTRASSE CH-4332 STEIN SWITZERLAND.,NOVARTIS PHARMA PRODUKTIONS GMBH-OEFLINGER STR.4479664 WEHR GERMANY

NOVARTISPHARMA AG -LICHTSTRASSE 35CH-4056 BASELSWITZERLAND,AND

NOVARTISPHARMA STEIN AG SCHAFFHAUSERSTRASSENOVATIS CONSUMER HEALTH INC -ZYMA SA-CH- 1260 NYON SWITZERLAND

NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD

NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD

BIPHASIC ISOPHANE INSULIN (HUMAN)

NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD

NOVO NORDISK A/S - NOVO ALLE DK-2880 BAGSVAERD

Page 610: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ISOPHANE INSULIN (HUMAN) 100I.U/ML NOVO NORDISK PHARMA-NOVO ALLE DENMARK

HUMAN INSULIN 100 I.U/ML NOVO NORDISK PHARMA-NOVO ALLE DENMARK

HUMAN INSULIN 100 I.U/ML NOVO NORDISK PHARMA-NOVO ALLE DENMARK

ISOSORBIDE NITRATE 20MG EGYPT

CEFTRIAXONE 1G INDIA

ESOMEPRAZOLE 20MG INDIA

AMOXICILLIN 125MG/5ML INDIA

500 MG + 125 MG INDIA

GLUCOSE 50G/L INDIA

WATER FOR INJECTION N/A INDIA

OCTOBER PHARMA-1ST INDUSTRIAL ZONE STREET 25 PLOT 190 6TH OCTOBER CITY CAIRO

OKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIA

OKASA PHARMA PVT LTD-L-2, ADDITIONAL M.I.D.C. AREA, SATARA SATARA-415004, MAHARASHTRA, INDIA

OKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115

AMOXICILLIN + CLAVULANATE POTASSIUM

OKASA PVT LTD-346 KUNDAIM INDUSTRIAL ESTATE GOA, 403115

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

Page 611: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

METRONIDAZOLE 5MG/ML INDIA

INTRAVENOUS FAT EMULSION 20%W/V INDIA

CIPROFLOXACIN 0.2%W/V INDIA

SODIUM CHLORIDE 0.9%W/V INDIA

AMINO ACIDS/ELECTROLYTES 10%W/V+10%W/V INDIA

AMINO ACIDS/SORBITOL 5%W/V+5%W/V INDIA

BUDESONIDE INDIA

37.5MG + 325MG INDIA

ALBENDAZOLE 400MG/10ML INDIA

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

OTSUKA PHARMACEUTICAL INDIA PRIVATE LTD-VILLAGE – VASANA – CHACHARWADIP, TAL: SANAND, AHMADABAD

200MCG / ACTUATION

OXALIS LABS--VILLAGE THEDA,P.O.LODHIMAJRA ,TEHSIL BADDI,DIST .SOLAN (HIMACHAL PRADESH) - 174101INDIA

TRAMADOL HYDROCHLORIDE + PARACETAMOL

PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205

PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205

Page 612: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

LACTULOSE + ISPAGHULA HUSK 10G + 3.5G/ 15G INDIA

10MG/G INDIA

ORDNIDAZOLE 500MG INDIA

INDIA

HEPATITIS B VACCINE 1ML SOUTH KOREA

200MG/10MG CANADA

CANADA

TENOFOVIR ALAFENAMIDE 25MG CANADA

SOFOSBUVIR+LEDIPASVIR 400 MG+90 MG CANADA

PARACETAMOL+CHLORPHENIRAMINE MALEATE+PHENYLPROPANOLAMINE+CAFFEINE

500MG+4MG+25MG+30MG

PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205

PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205

EUPHORBIA PROSTATA DRY EXTRACT

PANACEA BIOTEC LTD-MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN (H.P) – 173 205

PANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205

DIPTHERIA TOXOID + TETANUS TOXOID + INACTIVATED W-B, PERTUSSIS + HBSAG + HIB (PRP-TT)

30 IU + 60 IU + 4 IU + 10MCG + 10 MCG

PANACEA BIOTEC LTD--MALPUR, BADDI, TEHSIL, NALAGARH, DIST. SOLAN HIMACHAL PRADESH – 173 205

PASTEUR MERIEUX CONNANGHT-SOUTH KOREA,LG LIFE SCIENCES LTD- 601, YONGJEI-DONG, IKSAN, JE

EMITICITABINE + TENOFOVIR ALAFENAMIDE

PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9

ELVITEGRAVIR+COBICISTAT+EMITRICISTABINE+TENOFOVIR ALAFENAMIDE

150MG + 150MG + 200MG + 10MG

PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9

PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9

PATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9COUNTRY: CANADA

Page 613: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EMTRICITABINE/TENOFOVIR 200MG/300MG

CROFELEMER 125 MG

RALTEGRAVIR POTASSIUM 25MG

RALTEGRAVIR POTASSIUM 100MG

2.5MG+2.5MG CANADA

TENOFOVIR DISOPROXIL FUMARATE 300MG

1000 MG + 125 MG GERMANY

500 MG + 62.5 MG GERMANY

PATHEON INC-ADDRESS: 2100 SYNTEX COURT, MISSISSAUGA, ONTARIO L5N 7K9COUNTRY: CANADA,TAKEDA GMBH-16515 ORANIENBURG GERMANY,ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA

CANADA/GERMAY/SOUTH AFRICA

PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA

UNITED STATES

PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA,MERCK SHARP & DOHME BV.-WAARDERWEG 39HAARLEM, - 2031 BN, NETHERLANDS,MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685SOUTH AFRICA

UNITED STATES

PATHEON PHARMACEUTICALS INC.-2110 E. GALBRAITH ROAD CINCINNATI, OH 45237-1625, USA,MERCK SHARP & DOHME BV.-WAARDERWEG 39HAARLEM, - 2031 BN, NETHERLANDS,MSD (PTY) LTD. -117-16TH ROAD, HALFWAY HOUSE, 1685SOUTH AFRICA

UNITED STATES

METHYLPREDNISOLONE ACETATE+ NEOMYCIN SULFATE

PATHEON YM INC. TORONTO- TORONTO, CANADA

PATHEON YM INC. TORONTO- TORONTO, CANADA,ASPEN PHARMACARE-7 FAIRCLOUGH ROAD KORSTEN PORT ELIZABETH, 6020 SOUTH AFRICA

CANADA/SOUTH AFRICA

AMOXICILLIN TRIHYDTATE + POTASSIUM CLAVULANATE

PENCEF PHARMA GMBH-BRITENBACHSTR ASSE 13 D-13509 BERLIN

AMOXICILLIN TRIHYDRATE + POTASSIUM CLAVULANATE

PENCEF PHARMA GMBH-BRITENBACHSTR ASSE 13 D-13509 BERLIN

BISMUTH SUBGALLATE + BISMUTH OXIDE + ZINC OXIDE

59 MG + 24 MG + 296 MG

PERFORMANCE HEALTH LTD-241 NAIN ROAD RETREAT SOUTH AFRICA 7945

SOUTH AFRICA

BISMUTH SUBGALLATE + BISMUTH OXIDE + ZINC OXIDE

22.5 MG + 8.75 MG + 107.5 MG

PERFORMANCE HEALTH LTD-241 NAIN ROAD RETREAT SOUTH AFRICA 7945

SOUTH AFRICA

Page 614: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PREGABALIN 25 MG GERMANY

PREGABALIN 150 MG GERMANY

PREGABALIN 75 MG GERMANY

PHENYTOIN SODIUM 50MG/ML ITALY

ATORVASTATIN 10MG GERMANY

ATORVASTATIN 20MG GERMANY

MEDROXYPROGESTERONE ACETATE 104MG/0.65ML BELGIUM

CLINDAMYCIN PHOSPHATE 150MG/ML BELGIUM

125MG/2ML BELGIUM

METHYLPREDNISOLONE ACETATE 40MG/ML BELGIUM

PFIZER GMBH ARZEIMITELWORK -MOOSWADALLE 179090, FREIBERG GERMANY

PFIZER GMBH ARZEIMITELWORK -MOSWALDA 1144 79090 FREUBURG

PFIZER GMBH ARZEIMITELWORK -MOSWALDA 1144 79090 FREUBURG

PFIZER ITALIA SPA -STRADA STATALE, S.S 156KM, BORGO SAN - MICHELE LATINA - ITALY

PFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO

PFIZER LABORATORIES-GODECKE MOOSWALDALLE 179090 FR ,PFIZER PHARMACEUTICALS LLC, ROAD 689 KM 1.9 VEGA BAJA, PUERTO RICO

PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS

PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS

METHYLPREDNISOLONE HEMISUCCINATE

PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS

PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS

Page 615: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LATANOPROST 0.005%W/V BELGIUM

TINIDAZOLE 500MG FRANCE

FLUCONAZOLE 200MG FRANCE

FLUCONAZOLE 150MG FRANCE

SILDENAFIL 50MG

MULTI-INGREDIENT MULTI-INGREDIENT FRANCE

CLINDAMYCIN HYDROCHLORIDE 300MG FRANCE

AZITHROMYCIN 250MG EGYPT

AZITHROMYCIN DIHYDRATE 250MG/5ML EGYPT

CETIRIZINE DIHYDROCHLORIDE 5MG/5ML EGYPT

PFIZER MANUFACTURING -NV/NA, RIJKSWEG 12 2870, PUURS

PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

PFIZER PGM -AMBROISE ZONE INDUSTRIELLE 29 ROUTE DES INDUSTRIES 37530 POCE SUR CISSE

SOUTH AFRICA

PFIZER PGM ORLEANS FRANCE-AVENUE DE CONCYR, F-450

PFZIER PGM AMBOISE -ZONE INDUSTRIELLE , 29 ROUTE DES INDUSTRIES , 37530 POCE SUR CISSE

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

Page 616: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CETIRIZINE DIHYDROCHLORIDE 10MG EGYPT

EGYPT

CEPHALEXIN 250MG/5ML EGYPT

CEFADROXIL MONOHYDRATE 125MG/5ML EGYPT

CETRIMIDE+LIDOCAINE 25MG+3MG EGYPT

GLIBENCLAMIDE 5MG EGYPT

MICONAZOLE NITRATE 400MG EGYPT

MICONAZOLE NITRATE 2%W/W EGYPT

EGYPT

BENZOYL METRONIDAZOLE 200MG/5ML EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

SODIUM CARBONATE + TARTARIC ACID + CITRIC ACID

2.8G + 1.33G + 0.82G

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

SALBUTAMOL + AMMONIUM CHLORIDE

2MG/5ML +100MG/5ML

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

Page 617: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFOTAXIME SODIUM 1GM EGYPT

AMOXICILLIN 250MG/5ML EGYPT

AMOXICILLIN 125MG/5ML EGYPT

AMOXYCILLIN TRIHYDRATE 500MG EGYPT

GENTAMYCIN SULPHATE 0.I%W/W EGYPT

MICONAZOLE 2%W/W EGYPT

DICLOFENAC SODIUM 25MG EGYPT

EGYPT

VITAMIN E 400 MG EGYPT

MAGALDRATE+SIMETHICONE EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

DEXAMETHASONE + CHLORPHENIRAMINE MALEATE

10MG + 40MG/100ML

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

540MG + 40MG/5ML

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

Page 618: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOTRIMAZOLE 1%W/W EGYPT

DICLOFENAC SODIUM 12.5MG EGYPT

CLOTRIMAZOLE 1%W/V EGYPT

CLOTRIMAZOLE+ZINC OXIDE 0.01G + 2.500G EGYPT

DICLOFENAC SODIUM 100MG EGYPT

DOXORUBICIN HYDROCHLORIDE 10MG ITALY

RIFABUTIN 150MG ITALY

EPIRUBICIN HYDROCHLORIDE 10MG PHARMACIA AND UPJOHN S.P.A.-EUROPE EUROPE

AMINOSIDINE SULPHATE 250MG ITALY

CLINDAMYCIN HYDROCHLORIDE 150MG BELGIUM

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS LTD-KILO 31 ALEXANDRIA, CAIRO DESERT ROAD, ARAB REPUBLIC OF EGYPT.P. O BOX 12, SIDI GABER, ALEXANDRIA EGYPT

PHARCO PHARMACEUTICALS-KILO 31 ALEXANDRIA-CAIRO DESERT ROAD AMRIYA ALEXANDRIA

PHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALY

PHARMACIA AND UPJOHN S.P.A ITALY-VIA COMMESCION MARINO DEL TRONTO(ASCOLI PICENE)ITALY

PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS

PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS

Page 619: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLINDAMYCIN PALMITATE 75MG/5ML BELGIUM

CLINDAMYCIN PHOSPHATE 1%W/V BELGIUM

MEDROXYPROGESTERONE ACETATE 150MG/ML BELGIUM

DINOPROSTONE 3MG BELGIUM

ETOFENAMATE 5%W/W GREECE

BIFONAZOLE 10MG GREECE

BIFONAZOLE 1%W/W GREECE

ALLOPURINOL 100MG GREECE

CIPROFLOXACIN 500MG GREECE

PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS

PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS

PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS

PHARMACIA AND UPJOHN S.P.A-RIJKSWEG 12, B-2870 PUURS

LIDOCAINE HYDROCHLORIDE+ADRENALINE

21.33MG/1.8ML + 0.025MG/1.8ML

PHARMA-Q (PTY) LTD -50 COMMANDO ROAD INDUSTRIAL WEST, JOHANNESBURG

SOUTH AFRICA

PHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECE

PHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECE

PHARMATHEN LTD.-6 DERVENAKION STR. 153 51 PALLINI-GREECE

PHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE

PHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE

Page 620: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FLUCONAZOLE 100MG GREECE

OMEPRAZOLE 20MG GREECE

MEROPENEM 1000MG GREECE

MEROPENEM 500MG GREECE

AMIKACIN SULPHATE 500MG GREECE

ALLOPURINOL 300MG GREECE

BACITRACIN/NEOMYCIN SULPHATE 250/5000I.U/5MG AUSTRIA

CLOMIPHENE 50MG PAKISTAN

METFORMIN 500MG PAKISTAN

NAPROXEN SODIUM 500MG PAKISTAN

PHARMATHEN S.A--6,DERVENAKION STR .153 51,PALLINI,AHICA GREECE

PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE

PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE

PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE

PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE

PHARMATHEN S.A-6,DERVENAKION STR,PALLINI,AHICA GREECE

PHARMAZEUTISCHE FABRIK MONTAVIT GES M.B.H-SALZBERGSTRABE 96 6060 ABSAM/ TYROL,AUSTRIA

PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN

PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN

PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN

Page 621: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ALLOPURINOL 300MG PAKISTAN

CEFTRIAXONE 1000MG PAKISTAN

ATENOLOL 100MG PAKISTAN

CIPROFLOXACIN 500MG PAKISTAN

CETIRIZINE HYDRCHLORIDE 5MG/5ML IRELAND

IBUPROFEN 100MG/5ML IRELAND

PARACETAMOL 120MG/5ML IRELAND

IRELAND

METRONIDAZOLE 200MG INDIA

DICLOFENAC 50MG INDIA

PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN

PHARMEDIC LAB (PVT) LTD-# 4263, 16KM MULTAN RD, LAHORE PAKISTAN

PHARMEDIC LABORATORIES (PVT) LIMITED-16KM MULTAN ROAD,LAHORE-PAKISTAN

PHARMEDIC LABORATORIES LIMITED-16KM MULTAN ROAD,LAHORE-PAKISTAN

PINEWOOD LABORATORIES LTD. -BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND

PINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND

PINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND

SODIUM BICARBONATE + SODIUM ALGINATE + CALCIUM CARBONATE

267MG + 500MG + 160MG /10ML

PINEWOOD LABORATORIES LTD-BALLYMACARBRY, CLONMEL, TIPPERARY, IRELAND

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

Page 622: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AZITHROMYCIN 500MG INDIA

ACECLOFENAC 100MG INDIA

ACECLOFENAC+PARACETAMOL 100MG+500MG INDIA

50MG+500MG INDIA

LEVOFLOXACIN HEMIHYDRATE 500MG INDIA

METFORMIN 500MG INDIA

CIPROFLOXACIN 500MG INDIA

PARACETAMOL 650 MG INDIA

IBUPROFEN 200MG INDIA

ACECLOFENAC + PARACETAMOL 100MG +325MG INDIA

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

DICLOFENAC SODIUM+PARACETAMOL

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

PINNACLE LIFE SCIENCE PVT LTD-KHASRA NO. 1328-1330, VILLAG MANPURA, TEHSIL, BADDI, DIST. SOLAN (HP)

Page 623: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SPIRONOLACTONE 25MG

MISOPROSTOL 200MCG ITALY

50MG + 200MCG

ARTESUNATE 60MG INDIA

FUROSEMIDE 10MG/ML INDIA

TELMISARTAN 80MG INDIA

OLANZAPINE 5MG INDIA

AZITHROMYCIN 200MG/5ML INDIA

40MG + 12.5MG INDIA

TELMISARTAN 40MG INDIA

PIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND

UNITED KINGDOM

PIRAMAL HEALTHCARE LIMITED-WALTON ROAD MORPETH NORTHUMBERLAND NE 613YA

DICLOFENAC SODIUM + MISOPROSTOL

PIRAMAL HEALTHCARE UK LTD--WHALTON ROAD MORPETH NORTHUMBERLAND NE613 YA UK

UNITED KINGDOM

PSYCHOTROPICS INDIA LTD -PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA

PSYCHOTROPICS INDIA LTD -PLOT NO. 12 & 12A, INDUSTRIAL PARK-II, PHASE-1, VILLAGE SALEMPUR, MEHDOOD-2 HARIDWAR-249403, UTTARAKHAND INDIA

PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND

PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND

PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND

TELMISARTAN + HYDROCHLOROTHIAZIDE

PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND

PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND

Page 624: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OLANZAPINE 10MG INDIA

INDONESIA

ACICLOVIR 30MG/G INDONESIA

LEVOFLOXACIN HEMIHYDRATE 500 MG INDONESIA

PARACETAMOL 1000MG/100ML INDONESIA

PROPOFOL 1%W/V INDONESIA

TRANEXAMIC ACID 100MG/ML INDONESIA

OMEPRAZOLE 40MG INDONESIA

MECOBALAMIN 5000MCG INDONESIA

POLY (0-2-HYDROXYETHYL) STARCH 30G INDONESIA

PSYCHOTROPICS INDIA LTD-PLOT NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND, PSYCHOTROPICS INDIA LTD PLOT--NO. 46 & 49 SECTOR -6A IIE SIDCUL RANIPUR HARIDWAR 249403 UTTARAKHAND

DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE/CHLORPHENAMINE/GUAIFENESIN

10MG/30MG/2MG/100MG

PT NOVELL PHARMACEUTICAL LABORATORIES -J1 WANAHERANG NO. 35, TLAJUNG UDIK, GUNUNG

PUTRI, BORGO 16962INDONESIA

PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG

PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG

PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG

PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG

PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG

PT SANBE FARMA JI INDUSTRI-NO.8 KOMPLEKS INDUSTRI CIMAREME PADALARANG BANDUNG

PT SANBE FARMA,UNIT 1-JI INDUSTRI NO.9 LEUWIGAJAH CIMINDI CIMAHI WEST JAVA,INDONESIA

PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA

Page 625: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

POLY (0-2-HYDROXYETHYL) STARCH MW 200,000 INDONESIA

AMOXICILLIN + CLAVULANIC ACID 1000 MG + 200 MG INDONESIA

MEROPENEM 0.5G INDONESIA

MEROPENEM 1G INDONESIA

IMIPENEM + CILASTATIN 500MG + 500MG INDONESIA

125MG/VIAL INDONESIA

500MG/VIAL INDONESIA

INDONESIA

ARTEMETHER /LUMEFANTRINE 20MG /120MG UGANDA

CYCLOSPORIN 25MG GERMANY

PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA

PT SANBE FARMA-JI LEUIGAJAH NO. 162 CIMINDI, INDONESIA

PT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA

PT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA

PT SANBE FARMA-JI LEUWIGAJAH I62 CIMINDI CIMAHI WEST JAVA INDONESIA

METHYLPREDNISOLONE SODIUM SUCCINATE

PT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG

METHYLPREDNISOLONE SODIUM SUCCINATE

PT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG

PARACETAMOL + ASPIRIN + CAFFEINE

400MG + 250MG + 65MG

PT.CAPRIFARMINDO LABORATORIES-JI.INDUSTRI NO.8,KOMPLEKS INDUSTRI CIMAREME DESA CIMAREME,KEC PADALARANG,KAB BANDUNG

QUALITY CHEMICAL INDUSTRIES LIMITED. -PLOT NO. 1-7 LUZIRA INDUSTRIAL PARK, KAMPALA

R P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALEN

Page 626: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CYCLOSPORIN 100MG GERMANY

DICLOFENAC 100MG GERMANY

20MG/ML RAFARM S.A-AGIO LOUKA STR PEANIA ATTIKI GREECE

2MG/10MG/5MG INDIA

PREGABALIN 75MG INDIA

CEFACLOR 125MG/5ML INDIA

BEDAQUILINE FUMARATE 100MG INDIA

MULTI-INGREDIENT MULTI-INGREDIENT THAILAND

MULTI-INGREDIENT MULTI-INGREDIENT THAILAND

PREDNISOLONE 5.0 MG KENYA

R P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALEN

R P SCHERER GMBH & CO. EBERBACH BALEN-R P SCHERER GMBH & CO. EBERBACH BALEN

IRON (III) HYDROXIDE SUCROSE COMPLEX

CHLORPHENIRAMINE/DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL

RANBAXY LABORATORIES LTD AT: THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096

RANBAXY LABORATORIES LTD-PAONTA SAHIB, DISTRICT – SIRMOUR, HIRMACHAL

RANBAXY LABORATORIES-LABORATORIES LIMITED INDUSTRIAL AREA 3 DEWAS 455001

RECIPHARM PHARMACEUTICALS PVT LTD-34TH KM, TUMKUR ROAD, T-BEGUR, NELAMANGALA TALUK BENGALURU, INDIA

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED-65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THALAND

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED-RECKITT BENCKISER HEALTHCARE INTERNATIONAL-65 MOO 12,LARD KRABANG-BANGPLEE ROAD, BANGPLEE SAMUTPRAKARAN 10 540, THAILAND

REGAL PHARMACEUICALS LTD-PLOT NO 7879 OFF BABA DOGO ROAD KUARAKA NAIROBI

Page 627: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CETIRIZINE DIHYDROCHLORIDE 10MG KENYA

KENYA

KENYA

LOPERAMIDE HYDROCHLORIDE 2MG KENYA

KENYA

GRISEOFULVIN TABLETS 500MG KENYA

KENYA

KENYA

HYOSCINE-N-BUTYLBROMIDE 5MG/5ML KENYA

BENZOIC ACID + SALICYLIC ACID 6%W/W + 3%W/W KENYA

REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI

DAY TIME(PARACETAMOL +CAFFEINE ANHYDROUS+PSEUDOEPHDRINE HCL) AND NIGHT TIME(PARACETAMOL +CHLORPHENIRAMINE MALEATE)

DAY TIME (500MG + 30MG + 30MG) AND NIGHT TIME (500MG +2MG)

REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI

PARACETAMOL/PSEUDOEPHEDRINE HCL/CAFFEINE

500MG+30MG+30MG

REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI

REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI

CHLORPHENIRAMINE MALEATE+PSEUDO EPHEDRINE HCL+GUAIPHENISIN+MENTHOL

1.0MG+15.0MG+50.0MG+0.5MG / 5ML

REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI

REGAL PHARMACEUTICALS LIMITED -PLOT 7879/18 OF BABA DOGO ROAD, RUARAKA, NAIROBI

CHLORPHENIRAMINE MALEATE/PROMETHAZINE/DIPHENHYDRAMINE/EPHEDRINE/AMMONIUM CHLORIDE/SODIUM CITRATE

1.0MG+ 2.5MG+5.0MG+7.5MG+90.0MG+48.0MG/ 5ML.

REGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA

CHLORPHENIRAMINE MALEATE+ PARACETAMOL+ CAFFEINE ANHYDROUS+ PHENYLEPHRINE HCL

2MG+500 MG+30 MG+5MG

REGAL PHARMACEUTICALS LTD..-PLOT 7879/18 OFF BABA DOGO ROAD, RUARAKA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA, NAIROBI, KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

Page 628: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

QUININE HYDROCHLORIDE 100MG/5ML INDIA

ALBENDAZOLE 200MG KENYA

CO-TRIMOXAZOLE 240MG/5ML KENYA

KENYA

LEVAMISOLE HYDROCHLORIDE 40MG/5ML KENYA

AMOXYCILLIN TRIHYDRATE 125MG/5ML KENYA

CHLORPHENIRAMINE MALEATE 2MG/5ML KENYA

CLOXACILLIN+AMPICILLIN 250MG/5ML KENYA

CLOTRIMAZOLE 1%W/W KENYA

AMOXYCILLIN TRIHYDRATE 500MG KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

MAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE

500MG/5ML+250MG/5ML

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

Page 629: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE BENZOATE 200MG/5ML KENYA

METRONIDAZOLE 200MG KENYA

FOLIC ACID 5MG KENYA

5MG+4MG KENYA

KENYA

DEXTROMETHORPHAN 7.5MG/5ML KENYA

MEBENDAZOLE 100MG KENYA

MEPYRAMINE MALEATE 2%W/W KENYA

EPHEDRINE HYDROCHLORIDE 5MG/ML KENYA

EPHEDRINE HYDROCHLORIDE 10MG/ML KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

PARACETAMOL+PROMETHAZINE HYDROCHLORIDE+CODEINE PHOSPATE+PSEUDOEPHEDRINE HYDROCHLORIDE

120MG+6.5MG+5MG+25MG

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

Page 630: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ERYTHROMYCIN ETHYL SUCCINATE 125MG/5ML KENYA

IBUPROFEN 5%W/W KENYA

IBUPROFEN 100MG/5ML KENYA

IBUPROFEN 200MG KENYA

500MG+2MG KENYA

HYDROCORTISONE 1%W/W KENYA

KENYA

CO-TRIMOXAZOLE 480MG KENYA

ALBENDAZOLE 200MG/5ML KENYA

VITAMIN B COMPOUND N/A KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

PARACETAMOL+CHLORPHENIRAMINE

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

BETAMETHASONE VALERATE + SALICYLIC ACID

0.05% W/W + 3% W/W

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

Page 631: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT MULTI-INGREDIENT KENYA

MICONAZOLE NITRATE 2%W/W KENYA

PHENOXYMETHYLPENICILLIN 125MG/5ML KENYA

AMPICILLIN 125MG/5ML KENYA

CLOTRIMAZOLE 500MG & 1 %W/W KENYA

250MG+120MG KENYA

NALIDIXIC ACID 500MG KENYA

MULTIVITAMIN MULTI-INGREDIENT KENYA

HYDROCORTISONE 1%W/W KENYA

HYOSCINE BUTYLBROMIDE 10MG KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

MAGNESIUM TRISILICATE+ALUMINIUM HYDROXIDE

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

Page 632: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

KENYA

SULPHUR PRECIPITATED 10%W/W KENYA

TETRACYCLINE HYDROCHLORIDE 3%W/W KENYA

CHLORAMPHENICOL PALMITATE 125MG/5ML KENYA

PARACETAMOL 500MG KENYA

PARACETAMOL 120MG/5ML KENYA

KENYA

MULTI-INGREDIENT MULTI-INGREDIENT KENYA

KENYA

BETAMETHASONE VALERATE 0.1%W/W KENYA

DIPHENHYDRAMINE HYDROCHLORIDE+DEXTROMETHORPHAN+SODIUM CITRATE+MENTHOL

14MG+6.5MG+57MG+2MG

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

SALBUTAMOL SULPHATE + BROMHEXINE HYDROCHLORIDE + GUAIFENESIN

2MG/5ML + 4MG/5ML + 100MG/5ML

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

DIPHENHYDRAMINE HYDROCHLORIDE+SODIUM CITRATE+MENTHOL

7MG+28.5MG+0.55MG

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

Page 633: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PHENOXYMETHYLPENICILLIN 250MG KENYA

BETAMETHASONE VALERATE 0.1%W/W KENYA

KENYA

AMOXYCILLIN TRIHYDRATE 250MG KENYA

PROMETHAZINE HYDROCHLORIDE 5MG/5ML KENYA

CETYLPYRIDINIUM CHLORIDE 0.05%W/V KENYA

SALBUTAMOL 2MG/5ML KENYA

KENYA/INDIA

INDIA

GUAIFENESIN + MENTHOL KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

METHYL NICOTINATE + CAPSICUM OLEORESIN+ METHYLSALICYLATE

1%W/W+0.1%W/W+5%W/W

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA

PARACETAMOL + ASPIRIN + CAFFEINE

250 MG+ 300 MG + 30 MG

REGAL PHARMACEUTICALS LTD-BABA DOGO ROAD, RAURAKA,NAIROBI,KENYA,LINCOLN PHARMACEUTICALS LTD--TRIMUL ESTATE AFER VODSAR VILLAGE KHATJAT 382 721 GUJARAT VADSAR P.O.J TALUKA KALOH DIST GANDHINAGAR INDIA,MILAN LABORATORIES (INDIA) PVT LTD - -63,67,87,35,36, 64, 65 ASPIRIN+PARACETAMOL+CAFFEINE

ANHYDROUS150MG+250MG+300MG

REGAL PHARMACEUTICALS LTD-OFF BABA DOGO RD, RUARAKA, NAIROBI, KENYA

100MG/5ML + 1.1MG/5ML

REGAL PHARMACEUTICALS-PLOT 7879/18 BABA DOGO ROAD NAIROBI

Page 634: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1%W/W + 1%W/W KENYA

ASPIRIN 75MG INDIA

NIFEDIPINE 10MG CYPRUS

NORETHISTERONE 5MG CYPRUS

METFORMIN 850MG CYPRUS

CLOMIPHENE 50MG CYPRUS

AMOXICILLIN + CLAVULANIC ACID 500 MG + 125 MG CYPRUS

AMOXICILLIN + CLAVULANIC ACID 250 MG + 125 MG CYPRUS

CEPHALEXIN MONOHYDRATE 125MG/5ML CYPRUS

AMOXYCILLIN 250MG CYPRUS

CLOTRIMAZOLE + HYDROCORTISONE

REGAL PHERMACUTICALS -PLOT 7879/18 OFF BABA RWARAKA NAIROBI KENYA

REMEDEX PHARMA-B-249/250 PEENYA INDUSTRIAL ESTATE BANGALORE 560 058

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

Page 635: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NIFEDIPINE 20MG CYPRUS

CEFALEXIN MONOHYDRATE 250MG CYPRUS

DOXYCYCLINE HYDROCHLORIDE 100MG CYPRUS

KETOCONAZOLE 200MG CYPRUS

TRIFLUOPERAZINE HYDROCHLORIDE 5MG CYPRUS

CARBIMAZOLE 5MG CYPRUS

BROMOCRIPTINE MALEATE 2.5MG CYPRUS

ALBENDAZOLE 200MG CYPRUS

HALOPERIDOL 5MG CYPRUS

DEXAMETHASONE 0.5MG CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED -AHARNON STREET, LIMASSOL INDUSTRIAL ESTATE. LIMASSOL, CYPRUS 3056, CYPRUS

REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL

REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL

REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL

REMEDICA LIMITED,-LIMASSOL INDUSTRIAL ESTATE, AHARNON ST, P.O. BOX 51706,3508 LIMASSOL

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

Page 636: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METFORMIN 500MG CYPRUS

GRISEOFULVIN 500MG CYPRUS

CLOTRIMAZOLE 1%W/W CYPRUS

CLOXACILLIN SODIUM 250MG CYPRUS

METHOTREXATE 2.5MG CYPRUS

ACICLOVIR 5%W/W CYPRUS

CLOTRIMAZOLE 100MG CYPRUS

ACYCLOVIR 200MG CYPRUS

ASPIRIN 75MG CYPRUS

CLARITHROMYCIN 500MG CYPRUS

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

Page 637: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CAPTOPRIL 25MG CYPRUS

CARBAMAZEPINE 200MG CYPRUS

AMPICILLIN/ CLOXACILLIN 500MG CYPRUS

ATENOLOL 100MG CYPRUS

CINNARIZINE 25MG CYPRUS

MEFENAMIC ACID 500MG CYPRUS

HALOPERIDOL BP 10MG CYPRUS

SODIUM VALPROATE 200MG CYPRUS

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

ATROPINE SULPHATE 1%W/V PAKISTAN

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMEDICA LIMITED-LIMASSOL INDUSTRIAL ESTATE, AHAR

REMIDEX PHARMA PVT LTD- B-249+ 250 II STAGE PEENYA INDUSTRIAL ESTATE BANGLORE 560058.

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

Page 638: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

5MG/2MG PAKISTAN

1MG/2MG PAKISTAN

CHLORAMPHENICOL 1%W/V PAKISTAN

3.6/2.4 MG PAKISTAN

BETAMETHASONE + NEOMYCIN PAKISTAN

CHLORAMPHENICOL 0.5%W/V PAKISTAN

DEXAMETHASONE/NEOMYCIN 1MG/3MG PAKISTAN

CIPROFLOXACIN HYDROCHLORIDE 3MG/ML PAKISTAN

TOBRAMYCIN/DEXAMETHASONE 3MG+1MG/ML PAKISTAN

LOPERAMIDE HYDROCHLORIDE 2MG UGANDA

PREDNISOLONE/CHLORAMPHENICOL

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

DEXAMETHASONE/CHLORAMPHENICOL

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

SALICYLIC ACID/SULPHUR COMPOUND

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

0.1 %W/V + 0.5 %W/V

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

REMINGTON PHARMACEUTICAL INDUS. PVT LTD-, 117 ALLAM

REMINGTON PHARMACEUTICAL INDUSTRIES (PVT) LTD-18 KM MULTAN ROAD LAHORE 53800 PAKISTAN

REMINGTON PHARMACEUTICALS (PVT) LTD-18KM, MULTAN ROAD, LAHORE 53800, PAKISTAN

RENE INDUSTRIAL LTD-RENE INDUSTRIES LTD, PLOT 680, KAMULI-KIREKA KAMPALA UGANDA

Page 639: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CO-TRIMOXAZOLE 240MG/5ML UGANDA

800MG + 160MG UGANDA

UGANDA

SALBUTAMOL SULPHATE 4MG UGANDA

100MG UGANDA

UGANDA

ZINC SULFATE MONOHYDRATE 20MG UGANDA

AMOXICILLIN TRIHYDRATE 125 MG / 5 ML UGANDA

AMPICILLIN 125MG/5ML UGANDA

CETIRIZINE HYDROCHLORIDE 10MG UGANDA

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKA

SULPHAMETHOXAZOLE + TRIMETHOPRIM

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI KIREKA

VITAMIN A + VITAMIN B2 + VITAMIN B1 + VITAMIN B6 + VITAMIN C + VITAMIN E + VITAMIN B3

1500IU/5ML + 1MG/5ML + 1MG/5ML + 0.5MG/5ML + 20MG/5ML + 100 IU/5ML + 10MG/5ML

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA

CHLORPROMAZINE HYDROCHLORIDE

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA

GLUCOSE ANHYDROUS + TRISODIUM CITRATE DIHYDRATE + SODIUM CHLORIDE + POTASSIUM CHLORIDE

13.5G + 2.9G + 2.6G + 1.5G

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA

RENE INDUSTRIES LIMITED-PLOT 680 KAMULI- KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

Page 640: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CIMETIDINE 200MG UGANDA

10MG + 4MG /5ML UGANDA

10MG +4MG /5ML UGANDA

FLUOXETINE 20MG UGANDA

MEBENDAZOLE 100MG/5ML UGANDA

PROMETHAZINE HYDROCHLORIDE 5MG/5ML UGANDA

PROPRANOLOL 40MG UGANDA

TRAMADOL HYDROCHLORIDE 50MG UGANDA

UGANDA

QUININE SULPHATE 300MG UGANDA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

CODEINE PHOSPHATE + CHLORPHENIRAMINE MALEATE

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

DEXTROMETHORPHAN HYDROBROMIDE + CHLORPHENAMINE MALEATE

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

PARACETAMOL+CAFFEINE CITRATE+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE

400MG+30MG+4MG+30MG

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

Page 641: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

EPHEDRINE HYDROCHLORIDE 30MG UGANDA

120MG+2MG+15MG UGANDA

CHLORAMPHENICOL 125MG/5ML UGANDA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG UGANDA

MEBENDAZOLE 100MG UGANDA

MULTI-INGREDIENT MULTI-INGREDIENT UGANDA

DOXYCYCLINE 100MG UGANDA

MULTIINGREDIENT N/A UGANDA

SULPHADOXINE + PYRIMETHAMINE 500MG/25MG UGANDA

AMOXICILLIN TRIHYDRATE 250MG/5ML UGANDA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

PARACETAMOL+CHLORPHENIRAMINE MALEATE+PSEUDOEPHEDRINE HYDROCHLORIDE

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LIMITED-PLOT 680, KAMULI ROAD, KIREKA

RENE INDUSTRIES LTD .-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA

RENE INDUSTRIES LTD .-PLOT 680, KAMULI ROAD, KIREKA, P.O. BOX 6034, KAMPALA

Page 642: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACETYL SALICYLIC ACID 300MG UGANDA

ACICLOVIR 200MG UGANDA

UGANDA

UGANDA

ALBENDAZOLE 200MG UGANDA

PYRIDOXINE HYDROCHLORIDE 25MG UGANDA

QUININE HYDROCHLORIDE 100MG/5ML UGANDA

QUININE 300MG UGANDA

METRONIDAZOLE 200MG UGANDA

METRONIDAZOLE 200MG UGANDA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

PARACETAMOL + ASPIRIN + CAFFEINE

500MG + 400MG + 50 MG

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

VITAMINS B1 + B2 + B6 + NIACINAMIDE

0.5 MG + 0.5MG + 7.5MG

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

Page 643: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE BENZOATE 200MG/5ML UGANDA

IBUPROFEN + PARACETAMOL 400MG + 500MG UGANDA

FOLIC ACID 5MG UGANDA

INDOMETHACIN 25MG UGANDA

KETOCONAZOLE 200MG UGANDA

NITROFURANTOIN 100MG UGANDA

UGANDA

PIROXICAM 20MG UGANDA

ALBENDAZOLE 400MG UGANDA

120MG + 250MG UGANDA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

VITAMIN B6 + FERROUS GLUCONATE + VITAMIN B1 + VITAMIN C + VITAMIN B2

2MG/5ML + 200MG/5ML + 2MG/5ML + 20MG/5ML + 2MG/5ML

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

Page 644: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CHLORPHENIRAMINE 4MG UGANDA

CIPROFLOXACIN 500MG UGANDA

TRAMADOL HYDROCHLORIDE 50MG UGANDA

ERYTHROMYCIN STEARATE 250MG UGANDA

MULTI-INGREDIENT MULTI-INGREDIENT UGANDA

METFORMIN HYDROCHLORIDE 500MG UGANDA

ARTEMETHER + LUMEFANTRINE 20 MG + 120 MG UGANDA

250MG + 250MG UGANDA

CO-TRIMOXAZOLE 480MG UGANDA

GRISEOFULVIN 500MG UGANDA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

MAGNESIUM HYDROXIDE + ALUMINIUM HYDROXIDE

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

Page 645: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CHLORAMPHENICOL 250MG UGANDA

ERYTHROMYCIN STEARATE 125MG/5ML UGANDA

TETRACYCLINE HYDROCHLORIDE 250MG UGANDA

PARACETAMOL 500MG UGANDA

120MG+250MG UGANDA

MULTI-INGREDIENT MULTI-INGREDIENT RENE INDUSTRIES-PLOT 680 KAMULI KIREKA UGANDA

CLOXACILLIN 250MG RENE INDUSTRIES-PLOT 680 KAMULI KIREKA UGANDA

AMPICILLIN 1G CHINA

4 M.U CHINA

AMPICILLIN 500MG CHINA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

ALUMINIUM HYDROXIDE+MAGNESIUM TRISILICATE

RENE INDUSTRIES LTD-PLOT 680, KAMULI ROAD, KIREKA, P.O BOX 6034, KAMPALA

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100

FORTIFIED PROCAINE PENICILLIN SODIUM

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100

Page 646: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

2.4MEGA/ VIAL CHINA

AMPICILLIN 1G CHINA

AMPICILLIN 500MG CHINA

BENZATHINE BENZYLPENICILLIN 2.4MEGA/VIAL CHINA

BENZYL PENICILLIN SODIUM 1MU CHINA

CEFTRIAXONE 1G CHINA

500MG CHINA

STREPTOMYCIN 1G CHINA

STREPTOMYCIN SULPHATE 1GM CHINA

1000MG+500MG CHINA

BENZATHINE BENZYLPENICILLIN SODIUM

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

CLOXACILLIN SODIUM FOR INJECTION

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

CEFTRIAXONE SODIUM+SULBACTAM

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

Page 647: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMPICILLIN SODIUM 500MG CHINA

BENZYLPENICILLIN 1MEGA CHINA

AMOXICILLIN 250MG CHINA

AMPICILLIN 250MG CHINA

500MG CHINA

1000MG + 125MG CHINA

DICLOFENAC SODIUM 25MG/ML INDIA

BENZYLPENICILLIN 1MU CHINA

AZITHROMYCIN 200MG/5ML EGYPT

EGYPT

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

CLOXACILLIN SODIUM FOR INJECTION

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

CEFTRIAXONE SODIUM + TAZOBACTAM

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100

REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PRRIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT

DI-IODO HYDROXYQUINOLINE/ PHTHALYL SULPHATHIAZOLE/ HOMATROPINE / STREPTOMYCIN

125MG/ 150MG/ 1MG/ 100MG

RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT

Page 648: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AZITHROMYCIN 500MG EGYPT

AMOXICILLIN TRIHYDRATE 500MG EGYPT

EPOETIN BETA 2000 IU/0.3ML GERMANY

100MG GERMANY

PANCURONIUM BROMIDE 4MG/2ML GERMANY

DIAZEPAM INJECTION 10MG/2ML GERMANY

METHYLERGOMETRINE MALEATE 20MCG/ML GERMANY

KETAMINE HYDROCHLORIDE 50MG/ML GERMANY

SUXAMETHONIUM CHLORIDE 50MG/ML GERMANY

PHYTOMENADIONE 10MG/ML GERMANY

RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT

RIVA PHARMA FREE ZONE-NASR CITY CAIRO EGYPT

ROCHE DIAGNOSTICS GMBH MANNHEIM -SANDHOFER STRABE 116, 68305, MANNHEIM

HYDROCORTISONE SODIUM SUCCINATE

ROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAU

ROTEX MEDICA GMBH-BUNSENSTRASSE 4 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

Page 649: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FLUPHENAZINE DECANOATE 25MG/ML GERMANY

ARTEMETHER 100MG/ML GERMANY

ARTEMETHER 40MG/ML GERMANY

LIDOCAINE 2%W/V GERMANY

ARTEMETHER 80MG/ML GERMANY

ARTEMETHER 20MG/ML GERMANY

LEVOFLOXACIN HEMIHYDRATE 500MG GERMANY

LEVOFLOXACIN HEMIHYDRATE 250MG GERMANY

200MG + 25 MG CANADA

AMLODIPINE 5MG GERMANY

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTEXMEDICA GMBH ARZEIMITTEL WERK-BUNSENSTRASSE 4, 22946 TRITTAU

ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY

ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY

EMTRICITABINE/TENOFOVIR ALAFENAMIDE

ROTTENDORF PHARMA GMBH-OSTENFELDER STRASSE 51-61 59320 ENNIGERLOH GERMANY,PATHEON INC.--TORONTO REGIONAL OPERATIONS 2100, SYNTEX COURT, MISSISSAUGA, ONTARIO, CANADA, L5N 7K9

R-PHARM GERMANY GMBH -HEINRICH-MACH-STRASSE 35,89257,ILLERTISSEN,GERMANY

Page 650: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PARACETAMOL 250MG RUBIEPHARM ARZNEIMITTEL GMHH -GERMANY GERMANY

PARACETAMOL 125MG RUBIEPHARM ARZNEIMITTEL GMHH -GERMANY GERMANY

CLOTRIMAZOLE 1%W/W GERMANY

MOXIFLOXACIN 5MG/ML BELGIUM

PARACETAMOL 10MG/ML ITALY

AMIKACIN 500MG INDIA

ARTEMETHER 80MG/ML INDIA

INDIA

CEFALEXIN 250MG INDIA

DEXAMETHASONE SODIUM 4MG/ML INDIA

RUBIEPHARM ARZNEIMITTEL GMHH--BRUDER-GRIMU, STRABE 62, GERMANY

S.A.ALCON COUVREUR N.V-RIJKSWEG 14, B-2870 PUURS BELGIUM

S.M FARMACEUTICI SRL-ZONA INDUSTRIALE, 85050 TITO-POTENZA(PZ) ITALY

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

CALCIUM CARBONATE + COLECALCIFEROL

250MG+125MG/5ML

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

Page 651: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN + CLAVULANIC ACID INDIA

INDIA

CEFALEXIN 250MG/5ML INDIA

CEFIXIME 50MG INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

INDIA

CEFUROXIME AXETIL 500MG INDIA

ONDANSETRON 2MG/ML INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

GENTAMICIN SULPHATE 80MG/2ML INDIA

125 MG/ 5 ML + 31.25 MG/ 5 ML

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

AMOXICILLIN + POTASSIUM CLAVULANATE

250 MG/5 ML + 62.5 MG/5 ML

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

ALUMINIUM HYDROXIDE + MAGNESIUM HYDROXIDE + SIMETHICONE

150 MG + 150 MG + 25 MG

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA

Page 652: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFTRIAXONE SODIUM 1G INDIA

CEPHALEXIN 250MG INDIA

CEPHALEXIN 125MG/5ML INDIA

Α-Β ARTEETHER 75MG/ML INDIA

DIAZEPAM 5MG/ML INDIA

INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

SAKAR HEALTH CARE PVT, LTD-BLOCK NO. 10-13,M.N DESAI PETROL PUMP,SARKHEJ-BAVLA ROAD,VILLAGE CHANGODAR DIST AHMEDABAD 382-213,GUJARAT-INDIA,REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG PROVINCE P.R. 256100,INJECTCARE PARENTERALS PVT. LTD.-PLOT130 SILVASSA ROAD GIDC VAPI 396195 GUJARAT,ZEISS PHARMACEUTICALS PVT LTD-72 EXPORT PROMOTION INDUSTRIAL PARK ,PHASE-1,JHARMAJRI, BADDI DIST:SOLAN H.P INDIA

SAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY, VILL: CHANGODAR, DIST: AHMEDABAD-382213, GUJARAT – INDIA.,SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SAKAR HEALTHCARE LIMITED-BLOCK NO. 10-13, SARKHEJ-BAVLA HIGHWAY,VILL: CHANGODAR, DIST: AHMEDABAD-382213,GUJARAT – INDIA.,SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX,

SAKAR HEALTHCARE PVT LTD --406, SILVER OAKS COMMERCIAL COMPLEX,

GUAIFENESIN+AMMONIUM CHLORIDE+CHLORPHENIRAMINE+SODIUM CITRATE

80MG+100MG+2MG+44MG

SAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA

SAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA

SAKAR HEALTHCARE PVT LTD-SAKAR HEALTHCARE PVT LTD, BLOCK NO 10-13, M.N. DESA

Page 653: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ALPHA -BETA ARTEETHER 150MG /2ML INDIA

ALPHA -BETA ARTEETHER 225MG/ 3ML INDIA

ALPHA-BETA ARTEETHER 75MG/ML INDIA

PROMETHAZINE 25MG/ML INDIA

QUININE DIHYDROCHLORIDE 300MG/ML INDIA

CEFUROXIME AXETIL 125MG/5ML INDIA

ANASTROZOLE 1MG GERMANY

HYDROCHLOROTHIAZIDE 25MG GERMANY

CEFEPIME 1000MG INDIA

CEFIXIME 100MG/5ML INDIA

SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA

SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA

SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA

SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA

SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA

SAKAR HEALTHCARE PVT. LTD-PLOT 10/13 SAKHEJ-BAVLA ROAD, AHMEDABAD,GUJURAT,INDIA

SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE 1, 39179 BARLEBEN,

SALUTAS PHARMA GMBH-OTTO-VON-GUERICKE-ALLEE 1, 39179 BARLEBEN,

SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.

SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.

Page 654: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFIXIME 400MG INDIA

CEFTRIAXONE+SULBACTAM 1000MG+500MG INDIA

CEFUROXIME 500MG INDIA

CEFTRIAXONE 1000MG INDIA

CEPHALEXIN 125MG/5ML INDIA

CEPHALEXIN 250MG INDIA

CEFTAZIDIME 1000MG INDIA

1G+0.5G INDIA

CEPHALEXIN 125MG/5ML INDIA

CEFTRIAXONE 1G INDIA/CHINA

SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.

SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.

SANCE LABORATORIES PRIVATE LTD-PB NO. 2 ELAPPUNKAL JN, KOOZLUVANAL , 686 523, PALA, KOTTAYAM DISTRICT, KERALA, INDIA.

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.

CEFTRIAXONE SODIUM+SULBACTAM SODIUM

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.

SANCE LABORATORIES PVT. LTD.-VI/B, P.B. NO. 2, KOZHUVANAL, PALA, KOTTAYAM DISTRICT-686573, KERALA, INDIA.,SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

Page 655: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN TRIHYDRATE 250 MG AUSTRIA

CEFADROXIL 500MG/5ML AUSTRIA

AMOXICILLIN + CLAVULANIC ACID 875 MG + 125 MG AUSTRIA

500MG+125MG AUSTRIA

CEFADROXIL (ANHYDROUS) 250MG/5ML AUSTRIA

CEFADROXIL (ANHYDROUS) 125MG/5ML AUSTRIA

CEFADROXIL (ANHYDROUS) 500MG AUSTRIA

CEFTRIAXONE SODIUM 1G AUSTRIA

4G+0.5G AUSTRIA

SIMVASTATIN 40MG TURKEY

SANDOZ GMBH BIOCHEMISTRASSE 10-6250 KUNDL, AUSTRIA

SANDOZ GMBH BIOCHEMISTRASSE 10-6250 KUNDL, AUSTRIA

SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA

AMOXYCILLIN + POTASSIUM CLAVULANATE

SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA

SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA

SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA

SANDOZ GMBH-BIOCHEMIESTRASSE 10, A6250 KUNDL, TYROL, AUSTRIA

SANDOZ GMBH-BIOCHEMIESTRAΒE 10 A6250 KUNDL, TYROL, AUSTRIA

PIPERACILLIN SODIUM+TAZOBACTAM SODIUM

SANDOZ GMBH-BIOCHEMIESTRAΒE 10 A6250 KUNDL, TYROL, AUSTRIA

SANDOZ GRUP SAGLIK .-GEBZE 2 GOSB IHSAN DEDE CAD. 900. SOK 41480 GEBZE KOCAELI

Page 656: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SIMVASTATIN 20MG TURKEY

FUROSEMIDE 40MG INDIA

AZITHROMYCIN MONOHYDRATE 500MG ROMANIA

AZITHROMYCIN MONOHYDRATE 200MG/5ML ROMANIA

AZITHROMYCIN 500MG ROMANIA

FRANCE

FRANCE

RABIES VACCINE 1 DOSE FRANCE

YELLOW FEVER VACCINE 1 DOSE FRANCE

MULTI-INGREDIENT MULTI-INGREDIENT FRANCE

SANDOZ GRUP SAGLIK -GEBZE 2 GOSB IHSAN DEDE CAD. 900. SOK 41480 GEBZE KOCAELI

SANDOZ PVT LTD.--MIDC IND, AREA KALWE BLOCK VILLAGE DIGHE NAVI MUMBAI 400708

SANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIA

SANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIA

SANDOZ SRL LTD-LIVEZENI STREET 7A540472 TARGU MURES ROMANIA

DIPHTERIA/ TETANUS/ AND (INACTIVATED) POLIOMYELITIS VACCINE (ADSORBED)

2 IU/ 20IU/ POLIOMYELITIS (40DU/ 8DU/ 32DU)

SANOFI PASTEUR CAMPUS MERIEUX--1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

DIPHTHERIA/ TETANUS/ PERTUSSIS (ACELLULAR, COMPONENT) POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED)

301IU/ 401IU/ 25MCG/ POLIOMYELITIS - 40DU (TYPE 1)/ 8DU TYPE 2/ 32DU TYPE 3

SANOFI PASTEUR CAMPUS MERIEUX--1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

Page 657: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MENINGOCOCCAL A+C VACCINE FRANCE

160 ANTIGEN UNITS FRANCE

80 ANTIGEN UNITS FRANCE

FRANCE

TYPHOID VACCINE 2MCG/DOSE FRANCE

TETANUS VACCINE 40 I.U FRANCE

ALFUZOSIN 10MG FRANCE

ENOXAPARIN SODIUM 100MG/ML FRANCE

ENOXAPARIN SODIUM 100MG/ML FRANCE

50MCG/0.5ML + 50MCG/0.5ML

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

INACTIVATED HEPATITIS A VACCINE ADSORBED

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

INACTIVATED HEPATITIS A VACCINE ADSORBED

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

INFLUENZA VIRUS STRAINS H1N1 + H3N2 + B

15MCG + 15MCG + 15MCG

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

SANOFI PASTEUR-1541 AVENUE MARCEL MERIEUX, 69280 MARCY, LETOILE

MENINGOCOCCAL GROUPS (A + C +Y + W-135) + POLYSACCHARIDE DIPTHERIA TOXOID CONJUGATE VACCINE

4MCG + 4MCG + 4MCG + 4MCG + 48MCG

SANOFI PASTEUR-INC DISCOVERY DRIVE SWIFTWATER PENNSYLVANIA 183370-0187

UNITED STATES

SANOFI WINTHROP INDUSTRIE,-30-36, AVENUE GUSTAVEEIFFEL BP 27166 - 37071 TOURS CEDEX 2

SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX

SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX

Page 658: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ENOXAPARIN SODIUM 100MG/ML FRANCE

ENOXAPARIN SODIUM 100MG/ML FRANCE

AMIODARONE HYDROCHLORIDE 200MG FRANCE

AMIODARONE HYDROCHLORIDE 50MG/ML FRANCE

CEFPODOXIME 200MG FRANCE

CEFPODOXIME PROXETIL 100MG FRANCE

CEFPODOXIME 40MG/5ML FRANCE

DOCETAXEL TRIHYDRATE 80MG/4ML GERMANY

INSULIN HUMAN 100IU/ML GERMANY

RECOMBINANT HUMAN INSULIN 100 IU/ML GERMANY

SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX

SANOFI WINTHROP INDUSTRIE--180 RUE JEAN JUARES BP 4094702 MAISON ALFORT CEDEX

SANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE

SANOFI WINTHROP INDUSTRIE-LAGRAGE 33565 CARBON BLANC CEDEX FRANCE

SANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE56, RUE DE CHOISY AU BAC60205 COMPIÈGNE

SANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE56, RUE DE CHOISY AU BAC60205 COMPIÈGNE

SANOFI WINTHROP INDUSTRIE-SANOFI WINTHROP INDUSTRIE56, RUE DE CHOISY AU BAC60205 COMPIÈGNE

SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDINGH650 65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDINGH650 65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDINGH650 65926 FRANKFURT AM MAIN, GERMANY

Page 659: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

30%+70% GERMANY

INSULIN HUMAN 100 IU/ML INDIA

INSULIN GLARGINE 100 UNITS/ML GERMANY

INSULIN GLARGINE 100 UNITS/ML GERMANY

INSULIN GLARGINE 100 UNITS/ML GERMANY

DOCETAXEL TRIHYDRATE 20MG/ML GERMANY

3MG+0.3MG GERMANY

DESLORATIDINE 5MG

BETAMETHASONE DIPROPIONATE 0.5%W/W BELGIUM

0.25MG + 2MG BELGIUM

DISSOLVED INSULIN+CRYSTALLINE PROTAMINE INSULIN

SANOFI-AVENTIS DEUTSCHLAND GMBH -INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDINGH650 65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOECHST, BRUNINGSTRASSEN, BUILDING D-65926 FRANKFURT AM MAIN, GERMANY

SANOFI-AVENTIS DEUTSCHLAND GMBH-INDUSTRIEPARK HOESCHST,BRUNINGSTRASSEN BUIDING,H65065926, FRANKFURT AM MAIN

DROSPIRENONE + ETHINYLESTRADIOL

SCHERING GMBH UND CO. PRODUKTIONS KG-SITE 1: DOBEREINERSTRASSE 20, D 99427, WEIMAR SITE 2: REIBNERSTRASSE 12B, D 99427, WEIMAR

SCHERING PLOUGH CORPORATION-POINTE CLAIRE QUEBEC, MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA

NETHERLANDS

SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM

BETAMETHASONE + DEXCHLORPHENIRAMINE

SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIAM, MSD (PTY) LTD- LOCATED AT 117 16TH ROAD HALFWAY HOUSE SOUTH AFRICA

Page 660: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LORATADINE + PSEUDOEPHEDRINE 5MG + 120MG BELGIUM

LORATADINE 10MG BELGIUM

BETAMETHASONE + SALICYLIC ACID BELGIUM

MOMETASONE FUROATE 0.1%W/W BELGIUM

AMOXICILLIN + FLUCLOXACILLIN 500 MG + 500 MG EGYPT

LACTULOSE 3.350G/5ML EGYPT

FLUCLOXACILLIN + AMOXICILLIN 250MG+250MG EGYPT

LORATADINE 10MG EGYPT

AMOXICILLIN +FLUCLOXACILLIN EGYPT

BCG VACCINE(FREEZE DRIED) INDIA

SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM

SCHERING PLOUGH LABO N.V,-INDUSTRY PARK 30, 2220 HEIST OPDENBERG BELGIUM

0.5 %W/W + 0.3 %W/W

SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30, ZONE A 2220 HEIST-OP-DEN-BERG

SCHERING-PLOUGH LABO N.V--INDUSTRIE PARK 30,B-2220 HEIST-OP-DEN-BERG,BELGIUM

SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT

SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT

SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT

SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT

125MG/5ML+125MG/5ML

SEDICO PHARMACEUTICAL CO.-1ST INDUSTRIAL ZONE 6 TH OCTOBER CITY GIZA,EGYPT

1.33*100000 C.F.U/0.1ML

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

Page 661: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

HEPATITIS B VACCINE(RDNA) 10MCG /0.5ML INDIA

4000 I.U/1ML INDIA

2000 I.U/0.5ML INDIA

TETANUS TOXOID MULTI INGREDIENT INDIA

INDIA

MEASLES VACCINE LIVE 1000CCID INDIA

DIPHTHERIA TETANUS PERTUSIS NA INDIA

DIPHTHERIA & TETANUS TOXOID MULTINGREDIENT INDIA

MULTI-INGREDIENT INDIA

20MCG/ML INDIA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

RECOMBINANT HUMAN ERYTHROPOIETIN

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

RECOMBINANT HUMAN ERYTHROPOIETIN

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

MENINGOCOCCAL A CONJUGATE VACCINE

10MCG/ 0.5ML + 10-33MCG/0.5ML

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

MEASLES + MUMPS + RUBELLA VACCINE

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

HEPATITIS B VACCINE(RDNA) ADULT

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

Page 662: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TETANUS ANTITOXIN 1500 I.U INDIA

ERYTHROPOIETIN 5000IU/ 0.5ML INDIA

PARACETAMOL 500MG CHINA

TETRACYCLINE 250MG CHINA

AMOXICILLIN 250MG CHINA

INDOMETHACIN 25 MG CHINA

METRONIDAZOLE 200MG CHINA

INDOMETHACIN 25MG CHINA

4MU CHINA

LEVONORGESTREL 75MG CHINA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

SERUM INSTITUTE OF INDIA LTD-212/2 HADAPSAR, PUNE, 411028, INDIA

SHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINA

SHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINA

SHANDONG XIER KANGTAI PHARMACEUTICAL CO LTD-YANZHOU CITY, CHINA

SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD PRIVATE-PRIVATE ECONOMY ZONE,XINYAN TOWN, YANZHOU DISTRICT, JINING CITY,SHANDONG,CHINA PR

FORTIFIED PROCAINE BENZYLPENICILLIN

SHANDONG XIER KANGTAI PHARMACEUTICALS CO. LTD-PRIVATE ECONOMY GARDEN,XINYAN JINING CITY,SHANDONG,CHINA. REYOUNG PHARMACEUTICAL CO. LTD-NO. 6 ERLANGSHAN ROAD, YIYUAN, SHANDONG 256100.

SHANGHAI DAHUA PHARMACEUTICAL CO. LTD-CHANG ZENG FARM, CHONGMING COUNTY, SHANGHAI

Page 663: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

FORTIFIED PROCAINE PENICILLIN 4 MEGA UNIT CHINA

SALBUTAMOL 2MG/5ML EGYPT

160MG + 20MG ITALY

AMOXICILLIN 250MG CHINA

PARACETAMOL 500MG KENYA

PARACETAMOL 500MG KENYA

HEPATITIS A VACCINE 720 ELISA BELGIUM

HEPATITIS A VACCINE 1440 ELISA BELGIUM

AMOXICILLIN + CLAVULANIC ACID 1000 MG + 200 MG

AMOXICILLIN + CLAVULANIC ACID

SHIJIAZHUANG PHARMA GROUP-ZHOUGNUO, PHARMACEUTICAL

SIDECO PHARMACEUTICAL CO LTD- EGYPT-1ST INDUSTRIAL ZONE, 6 OCTOBER CITY- EGYPT

PIPERAQUINE TETRAPHOSPHATE + DIHYDROARTEMISININ

SIGMA- TAU I.F.R . S.P.A-VIA PONTINA KM 30,400 POMEZIA ROME

SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD-OSD WORKSHOP OF ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE, SECOND MEDICAL ZONE DATONG, SHANXI, CHINA

SMITHKLINE BEECHAM (NAIROBI)-NAIROBI, KENYA,BETA HEALTH CARE INTERNATIONAL LTD-MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYA

SMITHKLINE BEECHAM (NAIROBI)-NAIROBI, KENYA,BETA HEALTH CARE INTERNATIONAL LTD-MOGADISHU ROAD PLOT NO 209/6554 INDUSTRIAL AREA NAIROBI KENYA

SMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUM

SMITHKLINE BEECHAM BIOLOGICALS , BELGIUM- BELGIUM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

126 MG/ 5 ML + 31.25 MG/ 5 ML

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

Page 664: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

875 MG + 125 MG

AMOXICILLIN + CLAVULANIC ACID

AMOXICILLIN + CLAVULANIC ACID 200 MG + 28.5 MG

AMOXICILLIN + CLAVULANIC ACID 875 MG + 125 MG

AMOXICILLIN + CLAVULANIC ACID 1000 MG + 200 MG

AMOXICILLIN + CLAVULANIC ACID 500 MG + 100 MG

AMOXICILLIN + CLAVULANIC ACID 500 MG + 125 MG

AMOXICILLIN + CLAVULANIC ACID 400 MG + 57 MG

AMOXICILLIN + CLAVULANIC ACID 250 MG + 125 MG

AMOXICILLIN + CLAVULANIC ACID 500 MG + 100 MG

AMOXICILLIN + CLAVULANATE POTASSIUM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

400 MG + 57 MG / 5 ML

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

Page 665: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN + CLAVULANIC ACID

AMOXICILLIN + CLAVULANIC ACID 500 MG + 125 MG

SMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYA KENYA

PARACETAMOL+PHENYLEPHEDRINE 600MG+10MG SMITHLINE BEECHAM (NAIROBI)-NAIROBI, KENYA KENYA

FLUCLOXACILLIN 250MG

LEVOFLOXACIN HEMIHYDRATE 5MG/ML GERMANY

MEBEVERINE HCL 135MG

BETAHISTINE 8MG

MEBEVERINE 200MG

AMOXICILLIN 125MG/5ML INDIA

200 MG/ 5 ML + 28.5 MG/ 5 ML

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

SMITHKLINE BEECHAM PHARMACEUTICALS,-CLARENDON ROAD, WORTHING, WEST SUSSEX, BN148QH

UNITED KINGDOM

MAGNESIUM SULPHATE +SODIUM HYDROGEN CARBONATE +CITRIC ACID

17.4 %W/W+22.6 % W/W+19.5 % W/W

SMITHLINE BEECHAM CLARENDON RD WORTHIN-CLARENDON RD WORTHING WEST SUSSEX

UNITED KINGDOM

SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH--INDUSTRIESTR. 3 34212 MELSUNGEN GERMANY

SOLVAY PHARMACEUTICALS PV-VEERVEG 12 8121 AA 0187NETHERLAND

NETHERLANDS

SOLVAY PHARMACEUTICALS -VEERWENG 12,8121AA,DIST. THE NETHERLANDS

NETHERLANDS

SOLVY PHARMACEUTICALS LTD-VEERWEG 12 NL 8121 NETHERLANDS

NETHERLANDS

SPARSH BIO-TECH LTD -PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA

Page 666: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOXACILLIN 125MG/5ML INDIA

AMPICILLIN + CLOXACILLIN INDIA

CLOXACILLIN 250MG INDIA

PHENOXYMETHYL PENICILLIN 250MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

AMPICILLIN 250MG INDIA

AMPICILLIN 125MG/5ML INDIA

AMOXYCILLIN TRIHYDRATE 125MG/5ML INDIA

AMOXYCILLIN 250MG INDIA

875 MG + 125 MG INDIA

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

125MG/5ML + 125MG/5ML

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH LTD-PLOT NO.1 SURVEY NO.242/234/244, VILLAGE LAKHABARAD, JAMNAGAR-361006

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

Page 667: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

500 MG + 125 MG INDIA

250MG + 250MG INDIA

250MG +250MG INDIA

AMOXYCILLIN 250MG INDIA

AMOXICILLIN TRIHYDRATE 125MG INDIA

AMOXICILLIN TRIHYDRATE 250MG INDIA

PHENOXYMETHYLPENICILLIN 125MG/5ML INDIA

FLUCLOXACILLIN 250MG INDIA

250 MG + 125 MG INDIA

KETOCONAZOLE 200MG

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

AMOXICILLIN TRIHYDRATE + FLUCLOXACILLIN SODIUM

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

FLUCLOXACILLIN SODIUM + AMPICILLIN TRIHYDRATE

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

SPARSH BIO-TECH PVT. LIMITED-PLOT NO. 1;SURVEY NO. 242/243/244,LAKHABAVAD,JAMNAGAR-361 006, INDIA.

SPARSH BIO-TECH PVT. LTD .-PLOT NO. 1, SURVEY NO. 42/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA

SPARSH BIO-TECH PVT. LTD.--PLOT NO. 1, SURVEY NO. 242/243/244, VILLAGE LAKHABAVAD POST KHODIYAR COLONY DISTRICT, JAMNAGAR – 361006 GUJARAT INDIA

AMOXICILLIN TRIHYDRATE + CLAVULANATE POTASSIUM

SPARSH BIO-TECH PVT. LTD-PLOT NO. 1; SURVEY NO. 242/243/244, LAKHABAVAD, JAMNAGAR-361 006, INDIA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

Page 668: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MEBENDAZOLE 100MG

2%W/W+1%W/W

MICONAZOLE NITRATE 20MG/G

MICONAZOLE NITRATE 20MG/G

MICONAZOLE NITRATE 20MG/G

MEBENDAZOLE 20MG/5ML

KETOCONAZOLE 20MG/G

KETOCONAZOLE 20MG/G

MEBENDAZOLE 500MG

LOPERAMIDE HYDROCHLORIDE 2MG

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

MICONAZOLE NITRATE+HYDROCORTISONE

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

SPECPHARM HOLDINGS- 15TH ROAD HALFWAY HOUSE

SOUTH AFRICA

Page 669: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AZITHROMYCIN 500MG BANGLADESH

CEFIXIME 100MG/5ML BANGLADESH

CEFIXIME TRIHYDRATE 200MG BANGLADESH

CEFIXIME TRIHYDRATE 400MG BANGLADESH

CEFTRIAXONE 1G BANGLADESH

CEFPIROME 1G BANGLADESH

AMBROXOL HYDROCHLORIDE 15MG/5ML BANGLADESH

PARACETAMOL 120MG/5ML BANGLADESH

BANGLADESH

ESOMEPRAZOLE 40MG BANGLADESH

SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH

SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH

SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH

SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH

SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH

SQUARE CEPHALOSPORINS LTD-KALIAKOIR, GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESH

SQUARE PHARMACEUTICAL LIMITED (PABNA UNIT)-SQUARE ROAD, SALGARIA PABNA-6600 BANGLADESH

DRIED FERROUS SULPHATE+ZINC SULPHATE MONOHYDRATE+FOLIC ACID

150MG+61.8MG+0.5MG

SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED--DHAKA UNIT KALIAKOIR GAZIPUR – 1750, BANGLADESH

Page 670: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMBROXOL 75MG BANGLADESH

CETIRIZINE 10MG BANGLADESH

CIPROFLOXACIN 750 BANGLADESH

DICLOFENAC SODIUM 50MG INDIA

TRAMADOL HYDROCHLORIDE 50MG BANGLADESH

ZINC SULPHATE 20MG BANGLADESH

BANGLADESH

BECLOMETASONE DIPROPIONATE 250 ΜCG/PUFF BANGLADESH

ACECLOFENAC 100MG SQUARE PHARMACEUTICALS LTD-KALIAKOIR BANGLADESH

LEVOFLOXACIN HEMIHYDRATE 500MG SQUARE PHARMACEUTICALS LTD-KALIAKOIR BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

IPRATROPIUM BROMIDE+SALBUTAMOL SULPHATE

500MCG/2.5ML+2.5MG/2.5ML

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

SQUARE PHARMACEUTICALS LIMITED-KALIAKOIR GAZIPUR – 1750, BANGLADESH

Page 671: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OLOPATADINE HYDROCHLORIDE 0.1%W/V SQUARE PHARMACEUTICALS LTD-KALIAKOIR BANGLADESH

INDIA

AMINO ACIDS + MULTIVITAMINS INDIA

INDIA

INDIA

COLECALCIFEROL 400 I.U/ML INDIA

CYANOCOBALAMIN 5MCG INDIA

IODINATED POVIDONE 2%W/V INDIA

ACECLOFENAC 100MG INDIA

ACECLOFENAC 100MG INDIA

ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE+ MAGNESIUM TRISILICATE + SIMETICONE

200MG + 250MG + 250MG + 250MG + 125MG

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

MULTI INGREDIENTS STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

CALCIUM CITRATE +MAGNESIUM HYDROXIDE + ZINC SULPHATE + COLECALCIFEROL

1000MG+100MG+4MG+200.I.U

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

CHROMIUM,ZINC,THIAMINE,RIBOFLAVINE,PYRIDOXINE,FOLIC ACID,NICOTINAMIDE,ASCORBIC ACID

1.667MG,42MG,12MG,11.5MG,3.6MG,1.2MG,52.5MG,165MG

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

Page 672: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MICONAZOLE + CHLOROHEXIDINE INDIA

1MG/ 5MG/ 10MG INDIA

IMG+5MG+160MG INDIA

INDIA

MICONAZOLE + METRONIDAZOLE INDIA

IODINATED- POVIDONE 10%W/V INDIA

INDIA

INDIA

INDIA

5%W/W + 1%W/W INDIA

2%W/W + 0.05%W/W

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

CHLORPHENIRAMINE / PHENYLEPHRINE / DEXTROMETHORPHAN

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

CHLORPHENAMINE+PHENYLEPHRINE+PARACETAMOL

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

CHLORPHENIRAMINE + PHENYLEPHRINE + PARACETAMOL

2MG + 5MG + 650MG

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

2.0%W/W + 1.0%W/W

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

CAPSAICIN + DICLOFENAC + LEVOMENTHOL + METHYL SALICYLATE

0.438 G + 0.335 G + 0.135 G + 0.918 G

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

ALGINIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE

200MG + 250MG +250MG +250MG + 125MG

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

ALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE

200MG +250MG + 250MG + 250MG + 125MG

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

POVIDONE IODINE + METRONIDAZOLE

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

Page 673: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1%W/W + 5%W/W INDIA

INDIA

INDIA

INDIA

INDIA

INDIA

SALBUTAMOL 4MG INDIA

VANCOMYCIN HYDROCHLORIDE 500MG INDIA

INDIA

TETRACYCLINE HYDROCHLORIDE 250MG INDIA

POVIDONE IODINE + METRONIDAZOLE

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

ALGNIC ACID + MAGNESIUM HYDROXIDE +ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE + SIMETHICONE

200MG +250MG + 250MG + 250MG + 125MG

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

ACECLOFENAC + LINSEED OIL + METHYL SALICYLATE

1.5%W/W + 3.0W/W +10.0%W/W

STEDMAN PHARMACEUTICALS PVT LIMITED-NO. C-4, SIDCO PHARMACEUTICAL COMPLEX, ALATHUR, THIRUPORUR, KANCHEEPURAM DIST 603 110, TAMILNADU, INDIA

IODINATED POVIDONE + METRONIDAZOLE

1.0% W/V + 5.0% W/V

STEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR

ALGINIC ACID+ MAGNESIUM HYDROXIDE+ ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE

200MG+250MG+250MG+250MG+125MG/15ML

STEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR

ALGINIC + MAGNESIUM HYDROXIDE +DRIED ALUMINIUM HYDROXIDE + MAGNESIUM TRISILICATE +SIMETICONE

200MG+250MG+250MG+250MG+125MG/15ML

STEDMAN PHARMACEUTICALS PVT LTD...-C-4, SIDCO PHARMACEUTICAL COMPLEX ALATHUR, THIRUPORUR

STRIDES ARCOLAB LIMITED .-DEWAN & SONS IND. AREA, VEOOR, PALGHAR, MAHARASTRA

STRIDES ARCOLAB LIMITED .-OPP. 11M BILEKAHALLI, BANNERG

LAMIVUDINE + NEVIRAPINE + ZIDOVUDINE

150MG + 200MG + 300MG

STRIDES ARCOLAB LIMITED .-PLOT 9-12, DEWAN & SONS INDUSTRIAL AREA, VEOOR, PALGHAR, MAHARASHTRA 401404

STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA

Page 674: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDOMETHACIN 25MG INDIA

ERYTHROMYCIN 250MG INDIA

IBUPROFEN 200MG INDIA

1.2G INDIA

500MG + 100MG INDIA

OMEPRAZOLE 40MG INDIA

ARTEMETHER 80MG/ML INDIA

HYDROCORTISONE 500MG INDIA

100MG INDIA

INDIA

STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA

STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA,AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.STRIDES ARCOLAB LIMITED-DEWAN & SONS IND. AREA,VEOOR, PALGHAR, MAHARASTRA,AFRICURE PHARMACEUTICALS (INDIA) PRIVATE LIMITED-PLOT 9-12,DEWAN & SONS INDL. AREA, VEOOR,PALGHAR-401404. INDIA.

AMOXICILLIN + POTASSIUM CLAVULANATE

STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROADBANGALORE 560076INDIA

AMOXICILLIN + POTASSIUM CLAVULANATE

STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROADBANGALORE 560076INDIA

STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROADBANGALORE 560076INDIA

STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROADBANGALORE 560076INDIA

STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROADBANGALORE 560076INDIA

HYDROCORTISONE SODIUM SUCCINATE

STRIDES ARCOLAB LTD -BILEKAHALLI OPP IIM BANNERGHATTA ROADBANGALORE 560076INDIA

VITAMINS B1 + B2 + B6 + NIACINAMIDE

1MG +1MG +1MG +15MG

STRIDES SHASUN LTD .-PLOT 9-12 DEWAN & SONS INDL AREA VEOOR PALGHAR

Page 675: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE 200MG INDIA

MEROPENEM 500MG JAPAN

MEROPENEM 1G JAPAN

IMIPENEM + CILASTATIN 500MG + 500MG INDIA

385MG INDIA

MULTI INGREDIENT MULTI INGREDIENT INDIA

10MG/G+10MG/G INDIA

ENTECAVIR MONOHYDRATE 1MG INDIA

COAMOXICLAV 1.2G INDIA

CEFTRIAXONE 1G INDIA

STRIDES SHASUN LTD .-PLOT 9-12 DEWAN & SONS INDL AREA VEOOR PALGHAR MAHARASTRA INDIA

SUMITOMO PHARMACEUTICALS CO. LTD-JAPAN,ACS-DOBFAR ITALIA

SUMITOMO PHARMACEUTICALS CO. LTD-JAPAN,ACS-DOBFAR ITALIA

SUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIA

COMPOUND MAGNESIUM TRISILICATE

SUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIA

SUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIA

SILVER SULFADIAZINE + CHLORHEXIDINE GLUCONATE

SUN PHARMACEUTICALS INDUSTRIES LIMITED-INDUSTRIAL AREA 3, A.B ROAD, MADHYA, INDIA

SUN PHARMACEUTICALS INDUSTRIES LIMITED--SEZ UNIT 1,A-41,INDUSTRIAL AREA, PHASE VIIIA,S.A.S NAGAR,MOHALI-160071,PUNJAB,INDIA

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

Page 676: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CHLORAMPHENICOL 1G INDIA

ARTEMETHER 80MG/ML INDIA

ALPHA-BETA ARTEETHER 75MG/ML INDIA

QUININE 300MG/ML INDIA

MEROPENEM 500MG INDIA

PANTOPRAZOLE 40MG INDIA

NEOMYCIN + BACITRACIN 0.052G + 0.0432G INDIA

ARTESUNATE 120MG INDIA

BUPIVACAINE 5 MG/ML INDIA

HYDROCORTISONE 100MG INDIA

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

SWISS PARENTERALS PVT LTD 809- 809 KERALA IND ESTATE GIDC NR BAVLA DIST AHMEDABAD

SWISS PARENTERALS PVT LTD- 809, KERALA INDUSTRIAL ESTATE, G.I.D.C, BAVIA ROAD, DIST, AHMEDABAD, GUJARAT,INDIA

SWISS PARENTERALS PVT LTD- 809, KERALA INDUSTRIAL ESTATE, G.I.D.C, BAVIA ROAD, DIST, AHMEDABAD, GUJARAT,INDIA

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

Page 677: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

STREPTOMYCIN SULPHATE 1GM INDIA

INDIA

DIAZEPAM 5MG/ML INDIA

ARTESUNATE 60MG INDIA

4.0G + 0.5G INDIA

AMPICILLIN 500MG INDIA

HYDRALAZINE HYDROCHLORIDE 20MG/ML INDIA

ARTESUNATE 30MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

TRAMADOL HYDROCHLORIDE 100MG/2ML INDIA

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

THIAMINE HCL + RIBOFLAVIN + PYRIDOXINE HCL + NICOTINAMIDE

10MG + 0.1MG + 1MG + 10MG

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

PIPERACILLIN SODIUM + TAZOBACTAM SODIUM

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

Page 678: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LIDOCAINE HYDROCHLORIDE 2% W/V INDIA

CEFOTAXIME SODIUM 1G INDIA

ARTESUNATE 120 MG INDIA

TRAMADOL HYDROCHLORIDE 100 MG / 2 ML INDIA

ARTESUNATE 60MG INDIA

MEROPENEM 1G INDIA

5MG + 80MG /ML INDIA

HALOPERIDOL DECANOATE 50MG/ML INDIA

DICLOFENAC SODIUM 25MG/ML INDIA

MULTI-INGREDIENT MULTI-INGREDIENT PAKISTAN

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD.-809 KERALA IND ESTATE GIDC NEAR BAVLA DIST AHMEDABAD 38222O GUJARAT

SWISS PARENTERALS PVT LTD---809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 382 220 GUJARAT

BUPIVACAINE HYDROCHLORIDE + DEXTROSE

SWISS PARENTERALS PVT LTD---809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 382 220 GUJARAT

SWISS PARENTERALS PVT LTD---809 KERALA GIDC NR. BAVLA DIST AHMEDABAD 382 220 GUJARAT

SWISS PARENTERALS PVT. LTD -809, KERALA INDUSTRIAL ESTATE, G.I.D.C, BAVIA ROAD, DIST. AHMEDABAD, GUJARAT, INDIA. SWISS PHARMACEUTICALS PVT LTD-A159 SINDH INDUSTRIAL AREA KARACHI

Page 679: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1%W/W+0.5%W/W PAKISTAN

AZITHROMYCIN DIHYDRATE 250MG JORDAN

LOSARTAN POTASSIUM 50MG JORDAN

AZITHROMYCIN DIHYDRATE 500MG JORDAN

CLINDAMYCIN 300MG INDIA

ESOMEPRAZOLE 20MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

SILDENAFIL CITRATE 100MG INDIA

CELECOXIB 200MG INDIA

SILDENAFIL CITRATE 50MG INDIA

DEXAMETHASONE+NEOMYCIN SULPHATE

SWISS PHARMACEUTICALS PVT LTD-A159 SINDH INDUSTRIAL AREA KARACHI

THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDAN

THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDAN

THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY.-UM-AL-AMAD/PLANT ( RAZI ).P.O.BOX 151 UM-AL-AMAD 16197 JORDAN

THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096

THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096

THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096

THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096

THE MADRAS PHARMACEUTICALS..-NO. 137B, OLD MAHABALIPURAM ROAD, KARAPAKKAM, CHENNAI 600096

THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA

Page 680: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CARVEDILOL USP 6.25MG INDIA

CO-TRIMOXAZOLE 480MG INDIA

AZITHROMYCIN DIHYDRATE 500MG INDIA

CLINDAMYCIN HYDROCHLORIDE BP 150MG INDIA

IBUPROFEN + MENTHOL 5%W/W + 3% W/W

MULTI-INGREDIENT MULTI-INGREDIENT

MULTI-INGREDIENT MULTI-INGREDIENT

MULTI-INGREDIENT MULTI-INGREDIENT

MENTHOL 2%W/W

AMOXICILLIN 500 MG INDIA

THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA

THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA

THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA

THE MADRAS PHARMACEUTICALS-137-B,OLD MAHABALI PURAM ROAD,KARAPAKKAM,CHENNAL INDIA

THE MENTHOLATUM CO. LTD. -1 REDWOOD AVE PEEL PARK CAMPUS EAST KILBRIDE

UNITED KINGDOM

THE MENTHOLATUM COMPANY LTD- TWYFORD, BENKSHIRE, E

UNITED KINGDOM

THE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND

UNITED KINGDOM

THE MENTHOLATUM COMPANY LTD, TWYFORD,-1 REDWOOD AVENUE, PEEL PARK CAMPUS EAST KILBRIDE, G74 SCOTLAND

UNITED KINGDOM

THE MENTHOLATUM COMPANY LTD, TWYFORD,-TWYFORD, BENKSHIRE, E

UNITED KINGDOM

THEON PHARMACEUTICALS LIMITED.-VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA

Page 681: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFTRIAXONE 500MG INDIA

CEFTRIAXONE 1G INDIA

500MG INDIA

INDIA

INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

SILDENAFIL 50MG INDIA

INDIA

INDIA

MULTI INGREDIENT MULTI INGREDIENT INDIA

THEON PHARMACEUTICALS LIMITED.-VILLAGE SAINI MAJRA, TEHSIL NALAGARH, DISTT. SOLAN, HIMACHAL PRADESH 174 101 INDIA

THEON PHARMACEUTICALS LTD.-VILLAGE SAINI MAJRA, TEHSIL NALAGARH DIST, SOLAN- 174101,

COMPOUND MAGNESIUM TRISILICATE

TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA

L-LEUCINE USP + L-ISOLEUCINE USP + L-LYSINE HYDROCHLORIDE USP + L-PHENYLALANINE USP + L-THREONINE USP + L-VALINE USP+ L-TRYPTOPHAN USP + DL-METHIONINE USP + ASCORBIC ACID BP

0.84M+1.43MG+1.84MG+1.18MG+3.66MG+1.00MG+1.00MG+5.00MG+100MG

TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA

TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA

TIL HEALTH CARE-PLOT 100,WEST,R-5,SOUTH;SRICITY SEZ,CHERIVI,IRUHULAM,PSOT,SATYAVEDU MANDAL,CHITOOR DISTRICT-ANDRA PRADESH-517588, INDIA

TORQUE PHAMACEAUTICALS PVT LTD-VILL ISSAPUR P.O DAPPAR INDIA

PHENYLEPHRINE HCL + CHLORPHENIRAMINE MALEATE + DEXTROMETHORPHAN

5MG/5ML + 2MG/5ML + 10MG/5ML

TORQUE PHARMACEUTICALS (P) LTD-P.O.DAPPAR VILLISS

DIPHENHYDRAMINE HYDROCHLORIDE+AMMONIUM CHLORIDE+SODIUM CITRATE+MENTHOL

14.03MG+138MG+57.03MG+0.90MG

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

Page 682: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PIPERAZINE CITRATE 500MG/5ML INDIA

LEVAMISOLE HYDROCHLORIDE 40MG/5ML INDIA

MULTIINGREDIENT N/A INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

INDIA

MULTI INGREDIENT N/A INDIA

KETOCONAZOLE 2%W/V INDIA

MULTI-INGREDIENT N/A INDIA

NEOMYCIN SULPHATE 0.5%W/W INDIA

CETIRIZINE 10MG INDIA

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

PARACETAMOL+PHENYLEPHRINE HYDROCHLORIDE+CHLORPHENIRAMINE MALEATE+CAFFEINE

325MG+10MG+2MG+30MG

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

Page 683: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

METOCLOPROMIDE HCL 10MG INDIA

INDIA

INDIA

IBUPROFEN+PARACETAMOL INDIA

INDIA

ALBENDAZOLE 200MG/5ML INDIA

CYPROHEPTADINE 4MG INDIA

GUAIFENESIN+BROMHEXINE 100MG + 8MG/5ML INDIA

CLOTRIMAZOLE 1%W/W INDIA

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD -ISSAPUR P.O DAPPAR 140506

BECLOMETHASONE DIPROPRIONATE + PHENYLEPHRINE HCL + LIGNOCAINE HCL + CHLOROCRESOL

0.025%W/W + 0.1%W/W + 2.5%W/W + 0.1%W/W

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

BISMUTH AMMONIUM CITRATE+BELLADONA DRY EXTRACT+THYMOL+MENTHOL

140MG+9MG+0.15MG+0.2/5ML

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

200MG+ 250MG/10ML

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

BECLOMETHASONE+MICONAZOLE+NEOMYCIN

0.025%W/W + 2%W/W + 0.5%W/W

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

Page 684: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ALBENDAZOLE 200MG INDIA

PARACETAMOL 500MG INDIA

CYPROHEPTADINE 2MG/5ML INDIA

ACRIFLAVINE/THYMOL N/A INDIA

PROPRANOLOL HYDROCHLORIDE 40MG INDIA

IBUPROFEN + PARACETAMOL 400MG + 325MG INDIA

CHOLINE SALICYLATE/LIDOCAINE 8.7%W/W+2%W/W INDIA

CLOTRIMAZOLE 100MG INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

INDIA

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS LTD-ISSAPUR P.O DAPPAR 140506

TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA

VITAMINE A + VITAMINE E ACETATE + ASCORBIC ACID + SELENIUM + ZINC

2500 IU + 10 IU + 50MG + 35MCG + 3MG

TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA

Page 685: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

AZITHROMYCIN 500MG INDIA

LAMOTRIGINE 100MG INDIA

MEMANTINE HYDROCHLORIDE 10MG INDIA

SODIUM VALPROATE 300MG INDIA

500MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

CO-CARELDOPA 25MG/250MG INDIA

50MG + 12.5MG INDIA

CAPTOPRIL 25MG INDIA

ALUMINIUM HYDROXIDE/MAGNESIUM TRISILICATE

400MG+400MG/50ML

TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA

TORQUE PHARMACEUTICALS PVT LTD-ISAAPUR P.O DAPPAR 140056 INDIA

TORRENT PHAMACEUTICALS LTD-TORRENT PHAMACEUTICALS LTD INDRAD 382721 DIST MEHSANA INDIA

TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-282721

TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721

SODIUM VALPROATE (CONTROLLED RELEASE)

TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721

TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721

TORRENT PHARMACEUTICAL LTD-AHMEDABAD-MEHSANA HIGHWAY,TALUKA-KADI,DIST.MEHSANA,INDRAD-382721

LOSARTAN POTASSIUM + HYDROCHLOROTHIAZIDE

TORRENT PHARMACEUTICALS LIMITED -AHMEDABAD-MEHSANA HIGHWAY, TAL. KADI, DIST. MEHSANA, INDRAD 382 721, GUJARAT

TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)

Page 686: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IMIPRAMINE 25MG INDIA

40MG INDIA

CEFIXIME 200MG INDIA

LEFLUNOMIDE 20MG INDIA

CARBAMAZEPINE 200MG INDIA

NIFEDIPINE(SR) 20MG INDIA

CLOPIDOGREL 75MG INDIA

NITROFURANTOIN 100 MG INDIA

INDIA

INDIA

TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)

ESOMEPRAZOLE MAGNESIUM TABLET

TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)

TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)

TORRENT PHARMACEUTICALS LTD-INDRAD-382 721, DIST.MEHSANA,INDIA.AT:VILL.MANAKPUR,TEH.NALAGARH,DIST.SOLAN(H.P.)

TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA

TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA

TORRENT PHARMACEUTICALS LTD-INDRAD-382721, TAL KADI, AHMEDABAD, INDIA

TRIVENI FORMULATIONS LIMITED .- PLOT NO 52,53-54,63-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAN MANDAL KRISHNA

PARACETAMOL/PHENYLEPHRINE HYDROCHLORIDE/CAFFEINE ANHYDROUS/CHLORPHENIRAMINE

500MG/10MG/30MG/2MG

TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P

FERROUS SULPHATE+FOLIC ACID+PYRIDOXINE HCL+CYANOCOBALAMIN+ZINC SULPHATE

300MG+1000MCG+1.5MG+7.5MG+61.8MG

TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P

Page 687: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ACECLOFENAC 100MG INDIA

INDIA

CYPROHEPTADINE HYDROCHLORIDE 4 MG INDIA

CLOPIDOGREL 75MG INDIA

GRISEOFULVIN 500MG INDIA

PIROXICAM 20MG INDIA

INDIA

TRAMADOL 50MG INDIA

INDIA

DROTAVERINE HYDROCHLORIDE 20MG/ML INDIA

TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P

VITAMIN A + CHOLECALCIFEROL + THIAMINE + RIBOFLAVINE + PYRIDOXINE + NICOTINAMIDE

2500 IU + 200IU + 1MG +1MG + 0.5MG +15MG

TRIVENI FORMULATIONS LIMITED --PLOT NO 52-54,62-64 ALEAP INDUSTRIAL ESTATE SURAMPALLI (V) VIJAYAWADA A.P

TRIVENI FORMULATIONS LIMITED--PLOT NO: 52,53,54, 62,63 & 64 ALEAP INDUSTRIAL ESTATE SURAMPALI VILLAGE, GANNAVARAM MANDAL KRISHNA (DT) A.P

TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P

TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P

TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P

TERBUTALINE SULPHATE/ BROMOHEXINE/GUAIFENESIN

1.25MG/2MG/50MG

TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P

TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P

THIAMINE + RIBOFLAVIN + PYRIDOXINE + CYANOCOBALAMIN+ FOLIC ACID

250MG + 15MG + 200MG + 250MG + 500MCG

TRIVENI FORMULATIONS LTD .-PLOT NO. 52, 53,54 ALEAP INDUSTRIAL ESTATE SURAMPALLI VILLAGE GANNAVARAM MANDAL KRISHNA (DT) A.P

TROIKAA PHARMACEUTICALS LIMITED -THOL,DIST,MEHSANA PIN:382728 GUJARAT AHMEDABAD INDIA

Page 688: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

100MG/VIAL INDIA

ATRACURIUM 10MG/ML INDIA

PYTOMENADIONE 10MG/ML INDIA

PROPOFOL 1%W/V INDIA

DICLOFENAC 4%W/V INDIA

TRAMADOL 50MG/ML INDIA

TRAMADOL HYDROCHLORIDE 50MG INDIA

PARACETAMOL 500MG INDIA

KETAMINE 50MG/ML INDIA

CEFIXIME+CLAVULANIC ACID 50MG+31.25MG INDIA

HYDROCORTISONE SODIUM SUCCINATE

TROIKAA PHARMACEUTICALS LIMITED -THOL,DIST,MEHSANAPIN:382728 GUJARAT AHMEDABAD INDIA

TROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA

TROIKAA PHARMACEUTICALS LIMITED-THOL, DIST. MEHSANA-382728, GUJARAT,INDIA

TROIKAA PHARMACEUTICALS LTD .-C-1 SARA INDUSTRIAL ESTATE SELAQUI DEHRADUN 248197

TROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA

TROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA

TROIKAA PHARMACEUTICALS LTD-THOL VILLAGE, DIST. MEHSANA- 382728, GUJARAT, INDIA

TROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA

TROIKAA PHARMACUETICALS LIMITED-C-1 SARA INDUSTRIAL ESTATE, SELAQUI, DEHRADUN- 248197, UTTARAKHAND, INDIA

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

Page 689: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CEFIXIME 200MG INDIA

CEFIXIME 100MG/5ML INDIA

CEFADROXIL 250MG INDIA

CEFADROXIL 125MG/5ML INDIA

CEFUROXIME AXETL 125MG/5ML INDIA

CEFALEXIN MONOHYDRATE 125MG/5ML INDIA

CEFIXIME+CLAVULANIC ACID 200MG+125MG INDIA

CEFUROXIME AXETIL 500 MG INDIA

INDIA

500MG+125MG INDIA

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT LTD--ROORKEE DISTT HARIDWAR

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD - -UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE-247668. DIST.-HARIDWAR, UTTARAKHAND

AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE

200MG+28.5MG/5ML

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE

AMOXICILLIN TRIHYDRATE+POTASSIUM CLAVULANATE

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE

Page 690: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

250MG+125MG INDIA

AMOXICILLIN TRIHYDRATE 125MG/5ML INDIA

1G INDIA

STREPTOMYCIN SULPHATE 1G INDIA

KETAMINE HYDROCHLORIDE 50MG/ML INDIA

ACECLOFENAC SUSTAINED RELEASE 200MG INDIA

FEXOFENADINE HYDROCLORIDE 180MG INDIA

ACECLOFENAC + PARACETAMOL 100MG + 500MG INDIA

RANITIDINE 150MG INDIA

OMEPRAZOLE 20MG INDIA

AMOXICILLIN+POTASSIUM CLAVULANATE

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE

TWENTY FIRST CENTURY PHARMACEUTICALS PVT.LTD-UNIT II, KHASRA NO: 282, NALHERI DEHVIRAN, NALHERA ANANTPUR,PUHANA - IQBALPUR ROAD, ROORKEE

CHLORAMPHENICOL SODIUM SUCCINNATE B.P

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

Page 691: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOTRIMAZOLE 100MG INDIA

100MG INDIA

ACECLOFENAC 100MG INDIA

DICLOFENAC 100MG INDIA

LIDOCAINE HYDROCHLORIDE 2%W/V INDIA

CIPROFLOXACIN 500MG INDIA

FEXOFENADINE HYDROCLORIDE 120MG INDIA

CLOXACILLIN SODIUM 500MG INDIA

AMOXICILLIN 250MG INDIA

AMPICILLIN + CLOXACILLIN 125MG +125MG INDIA

UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.

HYDROCORTISONE SODIUM SUCCINATE

UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA

UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA

UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA

UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA

UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA

UMEDICA LABORATORIES PVT, VAPI-PLOT 221, GIDC II, VAPI-396195, INDIA

UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197

UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197

UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197

Page 692: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMPICILLIN 250MG INDIA

AMOXICILLIN TRIHYDRATE 125MG/5ML INDIA

250MG+250MG INDIA

500 MG + 125 MG INDIA

AMLODIPINE 5MG INDIA

TRAMADOL HCL 100MG/2ML INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

AMPICILLIN + CLOXACILLIN 250 MG + 250 MG INDIA

BISOPROLOL 5MG INDIA

CETIRIZINE DIHYDROCHLORIDE 10MG INDIA

UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197

UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197

AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM

UNI MEDICOLABS.- 21-22 PHARMACITY SELAQUI DEHRADUN 248197

AMOXICILLIN + CLAVULANATE POTASSIUM

UNI MEDICOLABS-21-22 PHARMACITY SELAQUI DEHRADUN 248197

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

Page 693: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TRAMADOL HYDROCHLORIDE 50MG INDIA

ATORVASTATIN 20MG INDIA

ATORVASTATIN 10MG INDIA

AMOXICILLIN + CLAVULANIC ACID 250 MG + 125 MG INDIA

AMOXILLICIN/CLAVULANATE 500MG/125MG INDIA

BISOPROLOL 10 MG INDIA

LEVOCETIRIZINE 5MG INDIA

MELOXICAM 15MG INDIA

50MG + 12.5MG INDIA

AMLODIPINE BESILATE 10MG INDIA

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED UNIT II-VILLAGE BHATAULI KALAN BADDI DIST SOLAN HIMACHAL PRADESH 173 205

UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

LOSARTAN + HYDROCHLOROTHIAZIDE

UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

UNICHEM LABORATORIES LIMITED-UNICHEM LABORATORIES LIMITED. UNIT II, VILLAGE BHATAULI KALAN, BADDI, DIST. SOLAN PIN CODE 173 205, HIMACHAL PRADESH, INDIA

Page 694: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

SECNIDAZOLE 1G INDIA

CETIRIZINE HYDROCHLORIDE 5MG/5ML INDIA

LANSOPRAZOLE 30MG INDIA

CELECOXIB 200MG INDIA

CELECOXIB 100MG INDIA

ALPRAZOLAM 0.25MG INDIA

LOSARTAN POTASSIUM 50MG INDIA

CO-TRIMOXAZOLE 240MG/5ML INDIA

PARACETAMOL 120MG/5ML INDIA

NICOTINAMIDE+SIMETHICONE+PAPAIN+FUNGAL DIASTASE+CHARCOAL

25MG+50MG+30MG+20MG+75MG

UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA

UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA

UNICHEM LABORATORIES LTD---C31 & 32 INDUSTRIAL AREA,THE MADRAS PHARMACEUTICALS-137-B OLD MAHABALIPURAM ROAD KARAPAKKAM CHENNAI 600 096

UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511

UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511

UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511

UNICHEM LABORATORIES LTD--PLOT 17 & 18, PILERNE IND. ESTATE, PILERNE, BARDEZ GOA-403511

UNICHEM LABORATORIES LTD---VILLAGE BHATAULI KALA, BADDI HIMACHAL PRADESH, INDIA

UNIMED INDIA.-UNI-MED HOUSE, 86,MAROL COOPORATIVE INDUSTRIAL ESTATE, M.V ROAD ANDHERE(E)MUMBAI 400059

UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROADANDHERE(E)MUMBAI 400059

Page 695: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE BENZOATE 125MG/5ML INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

MULTI-INGREDIENT MULTI-INGREDIENT INDIA

CO-TRIMOXAZOLE 480MG INDIA

ATENOLOL 100MG INDIA

ATENOLOL 50MG INDIA

RANITIDINE 25MG/ML INDIA

METRONIDAZOLE + CHLORHEXIDINE INDIA

CETIRIZINE DIHYDROCHLORIDE 10MG INDIA

RANITIDINE 150MG INDIA

UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROADANDHERE(E)MUMBAI 400059

UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROADANDHERE(E)MUMBAI 400059

UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROADANDHERE(E)MUMBAI 400059

UNIMED INDIA-86,MAROL COOPORATIVE ESTATE, M.V ROADANDHERE(E)MUMBAI 400059

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)-216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

1%W/W + 0.25%W/W

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--216-219 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

Page 696: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE 1%W/W INDIA

METRONIDAZOLE 5MG/ML INDIA

33.33%W/W INDIA

1.2MG + 0.6MG INDIA

1.2MG + 0.6MG INDIA

1.2MG+ 0.6MG INDIA

IOHEXOL 350MG INDIA

IOPAMIDOL 755.3MG/ML INDIA

1%+0.1%+0.025% INDIA

NIFEDIPINE 20MG INDIA

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

UNIQUE PHARMACEUTICAL LABORATORIES (A DIV. OF J.B CHEMICALS & PHARMACEUTICALS LTD)--304-308 GIDC INDUSTRIAL AREA PANOLI 394 116 DIST BHARUCH

DEXTROMETHORPHAN HYDROBROMIDE

UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210

2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL

UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210

2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESO

UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210

2,4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL

UNIQUE PHARMACEUTICAL LABORATORIES (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD)-SURVEY NO. 101/2 & 102/1 DAMAN INDUSTRIAL ESTATE KADAIYA DAMAN 396 210

UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116

UNIQUE PHARMACEUTICAL LABORATORIES, (A DIVISION OF J.B CHEMICALS & PHARMACEUTICALS LTD-PLOT NO 4, PHASE IV, GIDC INDUSTRIAL AREA, PANOLI 394 116

ECONAZOLE NITRATE + GENTAMYCIN + BECLAMETASONE

UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.

UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.

Page 697: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

METRONIDAZOLE 200MG/5ML INDIA

PARACETAMOL 10MG/ML INDIA

12MG+1.5MG INDIA

12MG+1.5MG INDIA

12MG+1.5MG INDIA

1.2MG + 0.6MG INDIA

DICLOFENAC SODIUM 50MG INDIA

CIPROFLOXACIN 500MG INDIA

DICLOFENAC DIETHYLAMONNIUM 1% W/W INDIA

DICLOFENAC SODIUM 25MG/ML INDIA

UNIQUE PHARMACEUTICAL LABORATORIES-PLOT NO. 215-219, G.I.D.C. INDUSTRIAL AREA,PANOLI — 394 116, GUJARAT, INDIA.,J.B. CHEMICALS AND PHARMACEUTICALS LTD .-128/1, GIDC, ANKLESHWAR 393 002, GUJARAT

UNIQUE PHARMACEUTICAL LABORATORIES--PLOT NO. 4 PASE IV, GIDC PANOLI -394 116GUJARAT INDIA

BENZOCAINE+CETYLPYRIDINIUM CHLORIDE

UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN – 396 210 INDIA

BENZOCAINE+CETYLPYRIDINIUM CHLORIDE

UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN – 396 210 INDIA

BENZOCAINE+CETYLPYRIDINIUM CHLORIDE

UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN – 396 210 INDIA

2, 4 DICHLOROBENZYL ALCOHOL + AMYLMETACRESOL

UNIQUE PHARMACEUTICALS LABORATORIES-SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN – 396 210 INDIA

UNIQUE PHARMACEUTICALS LABORATORIES--SURVEY NO. 101/2 AND 102/1, DAMAN INDUSTRIAL ESTATE, AIRPORT ROAD, KADAIYA, DAMAN –PLOT NO. 215-219, 396 210 INDIA

UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116

UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116

UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116

Page 698: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

INDIA

CIPROFLOXACIN 200MG/100ML INDIA

80MG + 12.5MG JORDAN

GLIMEPIRIDE 1MG JORDAN

MONTELUKAST 5MG JORDAN

DICLOFENAC 25MG JORDAN

FEXOFENADINE 120MG JORDAN

FEXOFENADINE 180MG JORDAN

GLIMEPIRIDE 2MG JORDAN

MONTELUKAST SODIUM 4MG JORDAN

DICLOFENAC+METHYL SALICYLATE+MENTHOL

1%W/W+10%W/W+5%W/W

UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116

UNIQUE PHARMACEUTICALS LABS ( A DIV OF J.B CHEMICALS & PHARMACEUTICAL LTD)--304-308 ,GIDC , PANOLI 394116

VALSARTAN + HYDROCHLOROTHIAZIDE

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .-57 UBAYBIN MUAATH STREET AL RAGEEM-SAHAB, AMMAN, JORDAN

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD .--P.O BOX 69 AMMAM 11591 JORDAN NUZHAT SAHID AL-RAQEEM NEAR PUBLIC HOUSING SECURITY

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

Page 699: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SODIUM VALPROATE 300MG JORDAN

VALSARTAN 80MG JORDAN

160 MG + 25 MG JORDAN

ROXITHROMYCIN 300MG JORDAN

SODIUM VALPROATE 200MG JORDAN

ETORICOXIB 60MG JORDAN

ETORICOXIB 90MG JORDAN

160MG + 12.5MG JORDAN

MONTELUKAST 10MG JORDAN

VALSARTAN 160MG JORDAN

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

VALSARTAN + HYDROCHLOROTHIAZIDE

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

VALSARTAN + HYDROCHLOROTHIAZIDE

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

UNITED PHARMACEUTICAL MANUFACTURING COMPANY LTD-P.O BOX 69 AMMAN 11591 JORDAN NUZHAT SAHAB AL-RAQEEM NERA PUBLIC SECURITY HOUSING

Page 700: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

SODIUM VALPROATE 200MG/5ML FRANCE

CARBOCISTEINE 20MG/ML FRANCE

CARBOCISTEINE 5%W/V FRANCE

ACYCLOVIR 5%W/W KENYA

CETIRIZINE 5MG/5ML KENYA

HYOSCINE BUTYL BROMIDE 10MG KENYA

LAMIVUDINE + ZIDOVUDINE 150MG +300MG KENYA

NYSTATIN 100000 I.U/ML KENYA

SECNIDAZOLE 500MG KENYA

160MG/800MG KENYA

UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770

UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770

UNITHER LIQUID MANUFACTURING INDUSTRIE -COLOMIERS 1-3 ALLE DE LA NESTE L DEN SIGAL 31770

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

TRIMETHOPRIM/SULFAMETHOXAZOLE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

Page 701: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CLOTRIMAZOLE 100MG KENYA

COTRIMOXAZOLE 480MG KENYA

GABAPENTIN 300MG INDIA

TRETINOIN 0.05%W/W KENYA

ACYCLOVIR 200MG KENYA

VANCOMYCIN 500MG INDIA

ENOXAPARIN 80MG INDIA

OXALIPLATIN 2MG/ML INDIA

METHOTREXATE 50MG INDIA

CISPLATIN 500MG/100ML INDIA

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LIMITED -PLOT 13777 KIKUYU ROAD, KIKUYU TOWN, PAST POST OFFICE

UNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU

UNIVERSAL CORPORATION LTD..-PLOT 13777 CLUB ROAD, PAST KIKUYU

UNIVERSAL CORPORATION LTD-KIKUYU NAIROBI KENYA

VENUS REMEDIES LIMITED-UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIPPHASE I BHATOLI BADDI (HP) 173205INDIA

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

Page 702: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MEROPENEM TRIHYDRATE 1000MG INDIA

PACLITAXEL 100MG/16.7ML INDIA

ENOXAPARIN SODIUM 40MG/0.4ML INDIA

PIPERACILLIN + TAZOBACTAM INDIA

GEMCITABINE 2MG/ML INDIA

20MG/ML INDIA

CEFTRIAXONE+SULBACTAM 1000MG+500MG INDIA

CEFTAZIDIME + SULBACTAM 1000 MG + 500 MG INDIA

DOXORUBICIN HCL 50MG/25ML INDIA

MEROPENEM 500MG INDIA

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

VENUS REMEDIES LTD --UNIT II HILL TOP INDUSTRIAL ESTATE JHARMAJRI EPIP PHASE I BHATOLI KALAN BADDI (H.P)

4000MG/VIAL + 500MG/VIAL

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

Page 703: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

CARBOPLATIN 450MG/45ML INDIA

DOCETAXEL 20MG/0.5ML INDIA

DOCETAXEL 80MG/2ML INDIA

CEFEPIME USP 1G INDIA

CEFTRIAXONE SODIUM 1000MG INDIA

PACLITAXEL USP 30MG/5ML INDIA

CARBOPLATIN 150MG/15ML INDIA

VINCRISTINE SULPHATE 1MG INDIA

IMIPENEM + CILASTATIN 500MG + 500MG INDIA

AMPHOTERICIN 50MG INDIA

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD, UNIT II,-HILL TOP INDUSTRIAL ESTATE, JHARMAJTI, EPIP, PHASE-1 (EXTENSION), BHATOLI KALAN, BADDI -HP

VENUS REMEDIES LTD.-UNIT 11 HOLL TOP INDUSTRIAL ESTATE JHARMAJRI

VENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIA

VENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIA

VENUS REMEDIES LTD-VNIT-11 HILL TOP INDUSTRAL ESTATE JHARRUJIRI EPIP INDIA

VENUS REMIDIES LTD-UNIT-11 HILL TOP INDUSTRIAL ESTATE JHARMATI

VENUS REMMEDIES-UNIT II HILLTOP INDUSTRIAL ESTATES JHARMAJRI EPIP PHASE 1 BHOTOLI KALA BADDI INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

Page 704: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

DOXORUBICIN HCL 10MG INDIA

CYTARABINE 100MG/ML INDIA

MEROPENEM 500MG INDIA

MEROPENEM 1G INDIA

CARBOPLATIN 450MG/ML INDIA

DOXORUBICIN 50MG INDIA

CEFTRIAXONE SODIUM,SULBACTAM 1G,0.5G INDIA

CISPLASTIN 1MG.ML INDIA

CEFTRIAXONE 1G INDIA

100MG/VIAL INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

HYDROCORTISONE SODIUM SUCCINATE

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

Page 705: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

BLEOMYCIN 15 UNITS INDIA

METHOTREXATE 50MG/2ML INDIA

250MCG/ML INDIA

100MCG/G INDIA

SODIUM HYALURONATE 10MG/1ML INDIA

PAPAIN + UREA INDIA

SILVER NITRATE 0.2%W/W INDIA

SODIUM HYALURONATE 11.9MG/0.85ML INDIA

CEFTRIAXONE + SULBACTAM 1G+500MG INDIA

AMOXICILLIN 125MG/5ML CYPRUS

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

VHB MEDI SCIENCES LTD-PLOT 20, 21, 22 & 49,50, 51. INTEGRATED INDUSTRIAL AREA SECTOR 5, RUDRAPUR, UTTARAKHAND - INDIA

TERIPARATIDE [RECOMBINANT HUMAN PARATHYROID HORMONE (1-34)] INJECTION

VIRCHOW BIOTECH PVT LTD -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT ANDHRA PRADESH

RECOMBINANT HUMAN PLATELET DERIVED GROWTH FACTOR -B

VIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST

VIRCHOW BIOTECH PVT, LTD-SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DIST

521700UNITS+100MG/G

VIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA

VIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA

VIRCHOW BIOTECH PVT, -SURVEY NO. 172, PART GAGILLAPUR, QUTHBULLAPUR, R.R, DISTRICT TELANGANA

VIRCHOW HEALTHCARE PVT LTD,-PLOT NO.130, SILVASSA ROAD, GGID VAPI-396 195, GUJURAT

VOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS

Page 706: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMOXICILLIN 500MG CYPRUS

URSODEOXYCHOLIC ACID 150MG INDIA

TRAMADOL HYDROCHLORIDE 50MG/ML INDIA

TRAMADOL HYDROCHLORIDE 50 MG INDIA

PARACETAMOL + CHLORZOXAZONE 500MG + 250MG INDIA

DICLOFENAC SODIUM 100MG INDIA

PARACETAMOL+DICLOFENAC 500MG+50MG INDIA

DICLOFENAC SODIUM 25MG/ML INDIA

LANSOPRAZOLE 30MG INDIA

DICLOFENAC SODIUM 50MG INDIA

VOGEN LABORATORIES LTD-70, M.HERACLEOUS STR. AYIOS ATHANASIOS INDUSTRIAL AREA, LIMASSOL, CYPRUS

WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.

WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.

WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.

WIN- MEDICARE LTD-MODIPURAM -250 110,UTTAR PRAADESH, INDIA.

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH -INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA

Page 707: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MEFENAMIC ACID 250MG INDIA

DICLOFENAC SODIUM 50MG INDIA

TRAMADOL/ PARACETAMOL 37.5MG/ 325MG INDIA

URSODEOXYCHOLIC ACID 300MG INDIA

FLUCONAZOLE 200MG INDIA

L-ORNITHINE-L-ASPARTATE 3G/5G INDIA

FLUCONAZOLE 150MG INDIA

L-ORNITHINE- L-ASPARTATE 5MG/ML INDIA

INDIA

PEFLOXACIN 400MG INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA

WIN MEDICARE PVT LIMITED-MEERUT, MUZAFFARNAGER ROAD, MODIPURAM – 250110, UTTAR PRADESH - INDIA

WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH

WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH

WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH

WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH

WIN-MEDICARE PRIVATE LIMITED-MEERUT-MUZAFFARNAGAR ROAD, MODIPURAM - 250110 UTTAR PRADESH

BROMHEXINE +AMMONIUM CHLORIDE+ MENTHOL + DEXTROMETHORPHAN

8MG+100MG+5MG+10MG

WOCKHARD LTD-WOCKHARDT TOWER BANDRA KURLA COMPLEX BANDRA EAST MUMBAI 400 051 INDIA

WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA

Page 708: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AZITHROMYCIN 250MG INDIA

AZITHROMYCIN 200MG/5ML INDIA

INDIA

4000 I.U INDIA

2000 IU INDIA

100I.U/ML INDIA

INSULIN 100ML INDIA

INSULIN GLARGINE 100IU/ML INDIA

NADIFLOXACIN 1%W/W INDIA

100IU/ML INDIA

WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA

WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA

TERBUTALINE SULPHATE +BROMHEXINE HYDROCHLORIDE+GUAIPHENESIN+MENTHOL

1.25MG+ 4 MG+50 MG+2.5 MG/5 ML

WOCKHARDT LIMITED --PLOT 57 VILLAGE KUNJHAL, JHAMAJRI, BAROTIWALA, BADDI, TEHSIL-NALAGARH, DISTRICT SOLAN, 174103 HIMACHAL PRADESH, INDIA

RECOMBINANT HUMAN ERYTHROPOIETIN

WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA

RECOMBINANT HUMAN ERYTHROPOIETIN

WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA

INSULIN HUMAN(RECOMBINANT DNA ORIGIN)

WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA

WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA

WOCKHARDT LIMITED --WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA INDIA

WOCKHARDT LTD -VILLAGE KUNJHAL P.O BAROTIWALA DIST SOLAN HIMACHAL PRADESH

INSULIN HUMAN(RECOMBINANT DNA ORIGIN)

WOCKHARDT-WOCKHARDT BIOTECH PARK, H14/2, M.I.D.C, WALUJ, AURANGABAD 431136 MAHARASHTRA

Page 709: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

MICONAZOLE + HYDROCORTISONE 2%W/W + 1%W/W MALAYSIA

CLOTRIMAZOLE 2%W/W MALAYSIA

DEXAMETHASONE + NEOMYCIN 0.1MG + 0.5MG MALAYSIA

MALAYSIA

KETOCONAZOLE 2%W/W MALAYSIA

ACYCLOVIR 200MG MALAYSIA

MALAYSIA

HYDROCORTISONE 1%W/W MALAYSIA

UREA 10%W/W MALAYSIA

PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT.ADSORBED)

2.2MCG OF POLYSACCHARIDE FOR SEROTYPES 1,3,4,5,6A,7F.9V,14,18C,23F,AND 4.4MCG FOR SEROTYPE 6B

WYETH PHARMACEUTICALS INC-401 N MIDDLETOWN RD PEARL RIVER NY 10965

UNITED STATES

XEPA SAUL PATTINSON MALAYSIA-1-5 INDUSTRIAL ESTATE 75250 MELAKA MALYSIA

XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

ALUMINIUM HYDROXIDE+MAGNESIUM HYDROXIDE+SIMETHICONE

200MG+200MG+20MG

XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

XEPA-SOUL PATTINSON (MALAYSIA) SDA BHD-1-5, CHENG INDUSTRIAL ESTATE, 75250, MELAKA, MALAYSIA

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA

DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE

14MG + 135MG + 57.5MG

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA

Page 710: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LORATADINE 10MG MALAYSIA

MALAYSIA

AMLODIPINE 5MG MALAYSIA

DICLOFENAC SODIUM 50MG MALAYSIA

TRETINOIN 0.05%W/W MALAYSIA

CEFTRIAXONE SODIUM 1000MG INDIA

ACETYLSALICYLIC ACID 100MG MALAYSIA

OFLOXACIN 2MG/ML UKRAINE

ORNIDAZOLE 5MG/ML UKRAINE

AMINOCARPROIC ACID 5G/100ML UKRAINE

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD-1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA

PARACETAMOL / PSEUDOEPHEDRINE / CHLORPHENIRAMINE

500MG / 30MG /2MG

XEPA-SOUL PATTINSON (MALAYSIA) SDN BLD -1-5 CHENG INDUSTRIAL ESTATE, 75250 MALEKA, MALAYSIA

Y.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA

Y.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA

Y.S.P.INDUSTRIES(M)SBD,BHD-LOT 3,5,& 7,JALANP/7,SECTION13,KAWASAN PERINDUSTRIAN BANDAR BARUBANGI,43000 KAJANG SELANGOR DARUL EHSAN, MALAYSIA

YELURI FORMULATIONS PVT. LTD-SY. NO. 296 / 7 / 6IDA BOLLARAM,MEDAK DIST.502325,TELANGANA,INDIA.

YSP INDUSTRIES SND.BHD-LOT 3,5&7 JOLAN P/7 SEC 13,KAWASAN PERINDUSTRIAN

YURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE..

YURIA-PHARM, LTD. -18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE..

YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.

Page 711: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

UKRAINE

LEVOFLOXACIN 5MG/ML UKRAINE

PARACETAMOL 10MG/ML UKRAINE

CIPROFLOXACIN 2MG/ML UKRAINE

PENTOXIFYLLINE 0.5MG/ML UKRAINE

DECAMETHOXIN 0.2MG/1ML UKRAINE

FLUCONAZOLE 2MG/ML UKRAINE

ISONIAZID 100MG/5ML UKRAINE

ARGININE HYDROCHLORIDE 42MG/ML UKRAINE

IBUPROFEN 400MG IRAN

SORBITOL + SODIUM LACTATE + NACL + CALCIUM CHLORIDE + MAGNESIUM CHLORIDE

6G +1.9G +0.6G + 0.01G +0.03G +0.02

YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.

YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.

YURIA-PHARM, LTD.-18030 VERBOVETSKOGO STR. 108 CHERKASSY, UKRAINE.

YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE

YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE

YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE

YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE

YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE

YURIA-PHARM, LTD-108, VERBOVETSKOGO STREET CHERKASSY, 18030, UKRAINE

ZAHRAVI PHARMACEUTICAL COMPANY-19TH KM TABRIZ TEHRAN ROAD OPPOSITE TO THE AGRICULTURE TRAINING CENTER TABRIZ

Page 712: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

IMIPENEM + CILASTATIN 500MG+500MG INDIA

CEFTRIAXONE SODIUM 1GM INDIA

20MG,160MG CHINA

40MG + 320MG CHINA

RALTEGRAVIR 400MG CHINA

GENTAMYCIN 80MG/2ML CHINA

INDOMETHACIN 25MG CHINA

100MG/VIAL CHINA

OXYTOCIN 10I.U/ML CHINA

DICLOFENAC SODIUM 25MG/ML CHINA

ZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA

ZEISS PHARMACEUTICALS PVT. LIMITED-PLOT NO. 72, EPIP I, JHARMAJIRI, BADDI (HP), INDIA,WOCKHARDT LIMITED-B-15/2 MIDC, WALUJ, AURANGABAD431136, MAHARASHTRA STATE, INDIA

DIHYDROARTEMISININ,PIPERAQUINE

ZHEIJIANG HOLLEY NANHU PHARMACEUTICAL CO. LTD.-NO.205,YUNHAI ROAD, JIAXING DEVELOPMENT ZONE, JIANXING CITY, ZHEJIANG PROVINCE

DIHYDROARTEMISININ + PIPERAQUINE PHOSPHATE

ZHEIJIANG HOLLEY NANHU PHARMACEUTICAL CO. LTD.-NO.205,YUNHAI ROAD, JIAXING DEVELOPMENT ZONE, JIANXING CITY, ZHEJIANG PROVINCE

ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD -ZHEIJIANG HUAHAI PHARMACEUTICAL CO LTD XUNQIAE LINHAI ZHIJIANG

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

HYDROCORTISONE SODIUM SUCCINATE

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

Page 713: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

AMINOPHYLLINE 25MG/ML CHINA

ATROPINE SULPHATE 1MG/ML CHINA

METOCLOPRAMIDE 5MG/ML CHINA

CHLORPROMAZINE 25MG/ML CHINA

PROMETHAZINE HCL 25MG/ML CHINA

QUININE DIHYDROCHLORIDE 600MG/2ML CHINA

CHINA

PARACETAMOL 500MG CHINA

CHLORAMPHENICOL 250MG CHINA

TETRACYCLINE 250MG CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO. LTD-KAIFA ROAD, LISHUI, ZHEJIANG P.R OF CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD-KAIFA ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA

VITAMIN B1 + VITAMIN B2 + SODIUM NICOTINAMIDE + VITAMIN B6 + D-PANTHENOL SODIUM

10MG + 1.37MG + 15MG + 1MG + 0.5MG

ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA

ZHEJIANG RUIXIN PHARMACEUTICAL CO., LTD--KAITEE ROAD, TIANNING INDUSTRIAL ZONE, LISHUI, ZHEJIANG, P.R.CHINA

Page 714: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

LIDOCAINE HYDROCHLORIDE 20MG/ML CHINA

DICLOFENAC SODIUM 75MG/3ML CHINA

ZHEJIANG RUIXIN PHARMACEUTICALS CO LTD-KAIFA ROAD TIANNING IDOUS ZONE LISHUI CITY

ZHEJIANG TIANFENG PHARMACEUTICAL FACTORY-NO.518 DA,KIVI PHARM CO. LTD-DONGSHAN HIGH TECH INDUSTRIAL DEVELOPMENT ZONE, XUANHUA,ZHANGJIAKOU CITY,HEBEI CHINA

Page 715: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

PRODUCT FORM PACK SIZE

1.0X500.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X500.0 ML BOTTLE

1.0X500.0 ML BOTTLE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X6.0 TABLET BLISTER

1.0X1.0 TABLET BLISTER

1.0X5.0X1.0 ML AMPOULE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY I M AMPOULES

Page 716: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 ML BOTTLE

VAGINAL TABLETS 1.0X6.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

1.0X60.0 MG VIAL + 1*5 ML AMPOULE OF 0.9%W/V NACL + 1*1 ML OF 5%W/V SODIUM BICARBONATE

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X10.0 TABLET BOTTLE,1.0X20.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 717: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X6.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 718: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X6.0 CAPSULE BLISTER

1.0X20.0 ML BOTTLE

1.0X3.0X10.0 TABLET STRIP

1.0X5.0X6.0 CAPSULE BLISTER

1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

1.0X2.0 G VIAL + 2*5 ML OF WFI GLASS AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 G VIAL + 2 PLASTIC AMPOULES OF WFI

PARENTERAL ORDINARY DRY VIALS

1.0X0.5 G VIAL + 1*5 ML OF WFI GLASS AMPOULES

PARENTERAL ORDINARY VIALS

1.0X5.0 ML VIAL + 1 ML AMPOULE 0.9%W/V NACL

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

Page 719: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X3.0 VIAL CARTON + 1X3X2ML WFI

1.0X2.0X1.0 CAPSULE STRIP

ORAL TOPICAL DROPS 1.0X30.0 ML BOTTLE

1.0X2.0 AMPOULE CARTON

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X2.0 ML VIAL

1.0X40.0X2.0X10.0 CAPSULE BLISTER

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X100.0 MG VIAL + 1*2ML AMPOULE OF WFI

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY CAPSULES

Page 720: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X2.0 ML AMPOULE

1.0X5.0X17.0 ML VIAL

1.0X100.0 ML BOTTLE,1.0X2.0 L BOTTLE

1.0X5.0 ML VIAL

1.0X5.0 ML AMPOULE

1.0X30.0 TABLET CONTAINER

1.0X160.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES

1.0X10.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL LIQUIDS

ORAL SOLID ORDINARY TABLETS

10.0X1.0X9.0 TABLET BLISTER,10.0X1.0X8.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

Page 721: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X20.0 TABLET BLISTER

1.0X30.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X3.0X6.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER,1.0X10.0X2.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X14.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X12.0X40.0 TABLET BLISTER,1.0X1.0X6.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY POWDERS

ORAL SOLID ORDINARY TABLETS

Page 722: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X20.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0X1.0 ML AMPOULE

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X1.2 G VIAL

1.0X2.0X10.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

1.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL LOTIONS

PARENTERAL ORDINARY AMPOULES

Page 723: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X28.0 TABLET BOTTLE

1.0X28.0 TABLET BOTTLE

1.0X10.0X1.2 G VIAL

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

1.0X30.0 ML VIAL

1.0X5.0X2.0 ML AMPOULE

1.0X3.0X10.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X60.0 ML BOTTLE,1.0X150.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

1.0X30.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL TOPICAL SUSPENSIONS

Page 724: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1000.0 CAPSULE CONTAINER

1.0X1000.0 CAPSULE CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

Page 725: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET BLISTER

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X2.5 ML AMPOULE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X3.0 TABLET BLISTER

1.0X4.0X7.0 TABLET STRIP

1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY OTHER TABLETS

LUNG ADMINISTRATION LIQUID FOR INHALATION

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X3.0X10.0 CAPSULE BLISTER

ORAL SOLID RETARD ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 726: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 CAPSULE BLISTER

1.0X7.0 TABLET BLISTER

1.0X7.0 TABLET BLISTER

1.0X20.0 ML VIAL

1.0X5.0X4.0 ML VIAL

1.0X2.0X10.0 TABLET BLISTER

1.0X1.0X5.0 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X5.0X1.0 ML AMPOULE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID RETARD ENTERIC-COATED TABLETS

ORAL SOLID RETARD FILM-COATED TABLETS

Page 727: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0 ML VIAL

1.0X20.0 G TUBE,1.0X45.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 728: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X90.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 729: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0X1.0 MU VIAL

1.0X10.0X25.0 G SACHET

1.0X30.0 G TUBE,1.0X15.0 G TUBE

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X15.0 TABLET BLISTER

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OTIC DROPS 1.0X10.0 ML VIAL,1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY SOLUBLE POWDERS

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL GELS AND SOLS

1.0X20.0 G TUBE,1.0X30.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 730: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

OTIC DROPS 1.0X10.0 ML BOTTLE

1.0X100.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE

PARENTERAL ORDINARY AMPOULES

1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE,1.0X7.5 ML AMPOULE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY DRY VIALS

1.0X120.0 MG VIAL + 1*10 ML SODIUM CHLORIDE IN GLASS AMPOULE + 1*2 ML SODIUM BICARBONATE IN GLASS AMPOULE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

Page 731: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X100.0 ML BOTTLE

NASAL SYSTEMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X500.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY OTHER INFUSIONS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE

Page 732: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 ML BOTTLE

1.0X500.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X20.0 TABLET BLISTER

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X1.0X120.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES

PARENTERAL ORDINARY COMBINATION PACK VIALS

1.0X1.0 VIAL CARTON,1.0X1.0 PREFILLED SYRINGE CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 733: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0 ML VIAL,1.0X8.0 ML VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

1.0X10.0 CAPSULE BLISTER

2.0X14.0 TABLET BLISTER

1.0X1.0X14.0 CAPSULE BOTTLE

1.0X10.0 TABLET BLISTER

1.0X40.0 CAPSULE CONTAINER

1.0X4.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL INSTILLATION VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY I M AMPOULES

1.0X1.0 ML AMPOULE,1.0X3.0 ML AMPOULE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY COATED TABLETS

Page 734: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X1.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

1.0X5.0 ML VIAL

1.0X5.0 ML VIAL,1.0X10.0 ML VIAL

1.0X500.0 ML BOTTLE

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID RETARD CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

Page 735: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X1.0 G VIAL + 1*1 10ML WFI AMPOULE

1.0X4.0 ML AMPOULE

1.0X12.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X48.0X2.0 TABLET STRIP

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY VIALS

1.0X10.0X1.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 G VIAL + 1*20ML AMPOULE OF WFI

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X500.0 MG VIAL + 1*10ML AMPOULE OF WFI

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

2.0X9.0 TABLET BLISTER,6.0X9.0 AMPOULE AMPOULE

ORAL SOLID ORDINARY TABLETS

Page 736: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 CAPSULE BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X200.0 METERED DOSE CONTAINER

1.0X4.0X14.0 TABLET BLISTER

1.0X4.0X14.0 TABLET BLISTER

1.0X250.0 ML BOTTLE

1.0X90.0 ML BOTTLE

1.0X250.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

LUNG ADMINISTRATION LIQUID FOR INHALATION

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

OTHER SYSTEMIC LIQUID INHALATIONS

ORAL LIQUID ORDINARY LIQUIDS

NASAL SYSTEMIC UNIT DOSE LIQUIDS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

Page 737: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X200.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X6.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE

Page 738: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X5.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X1.0X100.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X1.0X15.0 G TUBE

1.0X15.0 G TUBE

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X25.0X4.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET STRIP,1.0X10.0X1.0X3.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER

TOPICAL EXTERNAL EMULSIONS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL OINTMENTS

Page 739: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X20.0 G TUBE

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY CAPSULES

1.0X4.0 CAPSULE BLISTER,1.0X5.0X4.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET CARTON

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET STRIP

Page 740: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X2.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY OTHER CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

Page 741: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 G TUBE,1.0X5.0 G TUBE

1.0X1.0X6.0 CAPSULE BLISTER

1.0X1.0X100.0 ML BOTTLE

1.0X1.0X500.0 ML BOTTLE

1.0X20.0 G TUBE

1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY COMBINATION PACK POWDERS/GRANULES

4.0X500.0 ML SACHET 1*10 BLISTERS,10.0X200.0 ML SACHET 1*10 BLISTERS,2.0X1000.0 ML SACHET 1*10 BLISTERS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL LOTIONS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X30.0 ML BOTTLE,1.0X60.0 ML BOTTLE

TOPICAL EXTERNAL LIQUIDS

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SYRUPS

Page 742: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY OTHER CAPSULES

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY OTHER COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

Page 743: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X200.0 ML BOTTLE

Page 744: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X14.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X170.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X4.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 745: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

Page 746: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1000.0 CAPSULE CONTAINER,20.0X5.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X3.0X5.0 CAPSULE BLISTER,1.0X6.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 AMPOULE AMPOULE,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON

Page 747: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X25.0X4.0 TABLET STRIP

VAGINAL TABLETS 1.0X6.0 PESSARY STRIP

1.0X3.0 CAPSULE BLISTER

1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X4.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,2.0X6.0 TABLET BLISTER,4.0X6.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SOLUBLE POWDERS

1.0X500.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X200.0 ML SACHET

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

Page 748: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CHEWABLE TABLETS

10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SOLUBLE POWDERS

1.0X200.0 ML SACHET,1.0X1000.0 ML SACHET,1.0X500.0 ML SACHET

Page 749: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE

1.0X10.0 ML BOTTLE

1.0X4.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X250.0 BLISTER CARTON

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

Page 750: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X4.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X20.5 G SACHET

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X2.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER

ORAL TOPICAL SUSPENSIONS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SOLUBLE POWDERS

Page 751: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X100.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE,1.0X2.5 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

ORAL SOLID ORDINARY COATED TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET BOTTLE,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION BAGS

Page 752: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

1.0X2.0X7.0 TABLET BLISTER

1.0X30.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X1.0X100.0 ML BOTTLE

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

Page 753: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X2.0 TABLET BLISTER

1.0X2.0X6.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER,1.0X1.0X8.0 TABLET BLISTER,1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X30.0X12.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X6.0 TABLET BLISTER (WITH AMFM LOGO), 1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO), 30.0X1.0X6.0 TABLET BLISTER (WITH AMFM LOGO), 30.0X1.0X6.0 TABLET BLISTER (WITHOUT AMFM LOGO)

Page 754: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X4.0 TABLET BLISTER

1.0X10.0X2.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

ORAL SOLID ORDINARY LAYERED TABLETS

1.0X6.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER, AMPOULE AMPOULE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X6.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 755: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X3.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X20.0X6.0 G SACHET

1.0X3.0X10.0 TABLET BLISTER

1.0X5.0X2.0 ML AMPOULE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY POWDERS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 756: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X5.0X2.0 ML AMPOULE

1.0X1.0 G VIAL

1.0X5.0X5.0 ML AMPOULE

1.0X5.0X1.0 ML VIAL

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY LIQUIDS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY INFUSION AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X1.5 G VIAL + 1*10 ML LDPE AMPOULE OF SWFI

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X4.5 G VIAL ,2X10ML LDPE AMPOULES OF WFI

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 757: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X1.0X100.0 ML BOTTLE

1.0X3.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY OTHER TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 758: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 ML VIAL

1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X15.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X15.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY VIALS

OPHTHALMIC SUSPENSIONS

Page 759: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X2.5 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X3.5 G TUBE

1.0X6.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

OPHTHALMIC OINTMENTS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

Page 760: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X1.0 G VIAL

1.0X1.0 G VIAL

1.0X10.0 TABLET BLISTER

1.0X1.0X1.0 G VIAL

1.0X30.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X1.0X30.0 ML BOTTLE,1.0X70.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL LOTIONS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET STRIP,1.0X1.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 761: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET STRIP

1.0X2.0X10.0 TABLET STRIP

1.0X1.0X10.0 TABLET STRIP

1.0X1.0X10.0 TABLET STRIP

1.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0X4.5 G VIAL

1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X4.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 762: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X1.0X1.5 G VIAL

1.0X750.0 MG VIAL

1.0X750.0 MG VIAL

1.0X10.0X2.0 ML VIAL

1.0X10.0X4.0 ML VIAL

1.0X1.0 VIAL CARTON

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 763: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML AMPOULE

OPHTHALMIC DROPS 1.0X1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

OTIC DROPS 1.0X1.0X10.0 ML VIAL

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X300.0 ML BOTTLE,1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

Page 764: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET BLISTER

1.0X1.0X10.0 CAPSULE BLISTER

1.0X7.0 TABLET STRIP

1.0X15.0 G TUBE

1.0X6.0X5.0 ML AMPOULE

1.0X25.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X4.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY AMPOULES

ORAL TOPICAL SPRAYS WITHOUT GAS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL TOPICAL GELS AND SOLS

ORAL LIQUID ORDINARY SYRUPS

Page 765: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 ML BOTTLE

1.0X120.0 ML BOTTLE

1.0X1.0X5.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X125.0 ML BOTTLE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X6.0X1.0 ML AMPOULE

1.0X100.0X2.0 ML AMPOULE

10.0X10.0X3.0 ML AMPOULE

ORAL LIQUID ORDINARY SYRUPS

RECTAL SYSTEMIC ENEMA LIQUIDS

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X12.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER

ORAL SOLID ORDINARY COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 766: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 CAPSULE BLISTER

1.0X15.0 ML BOTTLE,1.0X22.5 ML BOTTLE

1.0X10.0X10.0 TABLET STRIP

1.0X1.0X200.0 ML BOTTLE

1.0X5.0X5.0 ML AMPOULE

1.0X15.0X10.0 TABLET BLISTER

1.0X200.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES

1.0X10.0X10.0 CAPSULE STRIP,1.0X3.0X10.0 CAPSULE STRIP

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X10.0X14.0 TABLET STRIP

Page 767: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X6.0 TABLET BLISTER

1.0X10.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X1.0X5.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY OTHER TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

Page 768: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X200.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID RETARD TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 769: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X1.0X4.0 TABLET BLISTER

VAGINAL TABLETS 1.0X15.0 PESSARY BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET STRIP,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 770: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 771: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X1.0 CAPSULE BLISTER

1.0X4.0 CAPSULE STRIP

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE STRIP,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

Page 772: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 TABLET BLISTER

1.0X2.0X15.0 TABLET BLISTER

1.0X25.0X4.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY OTHER COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

Page 773: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X15.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X25.0X4.0 TABLET BLISTER

ORAL SOLID ORDINARY OTHER COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X5.0X20.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

Page 774: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X2.0 TABLET STRIP

1.0X10.0 TABLET BLISTER

1.0X4.0X6.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 775: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X1.0X14.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY OTHER CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 776: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0X14.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X2.0X14.0 TABLET BLISTER

1.0X28.0 SACHET CARTON

1.0X4.0X5.0X2.0 ML VIAL

1.0X4.0X5.0X2.0 ML VIAL

1.0X2.0X14.0 TABLET BLISTER

1.0X1.0 PREFILLED SYRINGE CARTON

1.0X10.8 MG IMPLANT

1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY GRANULES

LUNG ADMINISTRATION LIQUID FOR INHALATION

LUNG ADMINISTRATION LIQUID FOR INHALATION

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL RETARD PRE-FILLED SYRINGES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

Page 777: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X14.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X60.0 DOSE CANNISTER

1.0X100.0 DOSE CANNISTER

1.0X60.0 DOSE CANNISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X14.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X14.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X14.0 TABLET BLISTER

PARENTERAL ORDINARY VIALS

1.0X1.0X5.0 ML VIAL,1.0X10.0X5.0 ML VIAL

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

LUNG ADMINISTRATION METERED-DOSE INHALER

LUNG ADMINISTRATION METERED-DOSE POWDER INHALER

ORAL SOLID ORDINARY TABLETS

1.0X4.0X7.0 TABLET BLISTER,1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X7.0 TABLET BLISTER,1.0X14.0 TABLET CARTON,1.0X28.0 TABLET CARTON

Page 778: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X14.0 TABLET BLISTER

2.0X14.0 TABLET STRIP

1.0X30.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE,1.0X5.0 G TUBE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL CREAMS

Page 779: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X7.5 ML VIAL

1.0X5.0 G TUBE,1.0X15.0 G TUBE

1.0X15.0 G TUBE,1.0X5.0 G TUBE

1.0X30.0 TABLET CONTAINER

1.0X4.0X7.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X2.0X5.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X5.0X4.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 780: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 CAPSULE CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

1.0X90.0 CAPSULE CONTAINER,1.0X30.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

Page 781: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 CAPSULE CONTAINER

1.0X240.0 ML BOTTLE

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X100.0 CAPSULE CONTAINER

1.0X60.0 TABLET BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 782: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X30.0 CAPSULE CONTAINER

1.0X100.0 ML BOTTLE

1.0X3.0X5.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X240.0 ML BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARYDRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X4.0X5.0 TABLET BLISTER,1.0X20.0X5.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X240.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 783: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0X15.0 TABLET BLISTER

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X120.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X30.0 CAPSULE CONTAINER

1.0X30.0 CAPSULE BOTTLE

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0 G VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID RETARD CAPSULES

ORAL SOLID RETARD CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

Page 784: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X60.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 G TUBE

1.0X15.0 G TUBE

1.0X30.0 G TUBE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

Page 785: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X200.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X20.0 G TUBE

1.0X20.0 G TUBE

1.0X3.0X10.0 TABLET BLISTER

OPHTHALMIC VIALS 1.0X2.0 ML PRE- FILLED SYRINGE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X2.5 ML BOTTLE

OPHTHALMIC LIQUIDS 1.0X10.0 ML CONTAINER

OPHTHALMIC LIQUIDS 1.0X5.0 ML VIAL

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY TABLETS

Page 786: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X500.0 MG VIAL

1.0X1.0 VIAL CARTON

1.0X500.0 G VIAL

1.0X1.0 G VIAL

1.0X100.0 ML BOTTLE

1.0X100.0 ML VIAL

1.0X100.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC SUSPENSIONS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

Page 787: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X15.0 ML BOTTLE,1.0X50.0 ML BOTTLE

6.0X10.0 TABLET BLISTER

1.0X12.0 SUPPOSITORY STRIP

1.0X15.0 G TUBE

1.0X10.0 G TUBE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY EFFERVESCENT TABLETS

1.0X72.0 TABLET STRIP,1.0X10.0 TABLET STRIP,1.0X20.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER

TOPICAL EXTERNAL LIQUIDS

ORAL SOLID RETARD FILM-COATED TABLETS

2.0X14.0 TABLET BLISTER,3.0X10.0 TABLET BLISTER

ORAL SOLID RETARD OTHER COATED TABLETS

RECTAL SYSTEMIC SUPPOSITORIES

TOPICAL EXTERNAL CREAMS

RECTAL SYSTEMIC UNIT DOSE OINTMENTS AND PASTES

Page 788: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X20.0 G TUBE

1.0X1.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

1.0 ML PRE- FILLED SYRINGE,1.0X100.0X1.0 ML VIAL

ORAL SOLID ORDINARY TABLETS

1.0X4.0 TABLET BLISTER,1.0X10.0 TABLET BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 789: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

1.0X50.0 ML VIAL

1.0X2.0X28.0 TABLET BLISTER

1.0X1.0 ML AMPOULE

1.0X50.0 G TUBE,1.0X15.0 G TUBE

1.0X14.0 TABLET BLISTER

1.0X14.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD TABLETS

PARENTERAL ORDINARY I V VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X30.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 790: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X14.0 TABLET BLISTER

1.0X100.0X28.0 TABLET BLISTER

1.0X3.0X1.0 IMPLANT STRIP

1.0X1.0 IMPLANT CARTON

1.0X3.0X35.0 TABLET BLISTER

1.0X3.0X28.0 TABLET BLISTER

1.0X40.0 G TUBE

1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL RETARD IMPLANTS

PARENTERAL RETARD IMPLANTS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X24.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X36.0X6.0 TABLET BLISTER,1.0X3.0X8.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER

TOPICAL EXTERNAL OINTMENTS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 791: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 TABLET CARTON

1.0X100.0 TABLET CARTON

1.0X60.0 ML BOTTLE

1.0X60.0 ML BOTTLE,1.0X50.0 ML BOTTLE

1.0X50.0 ML BOTTLE

1.0X50.0 ML BOTTLE

ORAL TOPICAL LIQUIDS

ORAL SOLID ORDINARY TABLETS

1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

Page 792: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0 ML BOTTLE

1.0X15.0X20.0 TABLET BLISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X120.0 METERED DOSE CANNISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X1.0 VIAL CARTON

1.0X2.0 ML VIAL

TOPICAL EXTERNAL LOTIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X50.0 TABLET BLISTER,1.0X50.0X1.0 TABLET BLISTER

TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS

TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS

TOPICAL EXTERNAL METERED-DOSE PRESSURISED AEROSOLS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

1.0X2.0X250.0 MG SACHET,1.0X10.0X250.0 MG SACHET

PARENTERAL ORDINARY DRY VIALS

1.0X5000.0 I.U VIAL + 1*1ML 0.9%W/V NACL AMBER GLASS AMPOULE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 793: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X10.0 ML VIAL

1.0X1.0X2.0 ML VIAL

1.0X1.0X5.0 ML VIAL

1.0X1.0 VIAL CARTON

1.0X1.0 VIAL CARTON

1.0X5.0 ML VIAL

1.0X1.0 VIAL CARTON

1.0X14.0 TABLET BLISTER

1.0X70.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL RETARD OTHER VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY S C VIALS

1.0X1.0 ML VIAL + 1*2ML GLASS AMPOULE OF DILUENT (EACH ML CONTAINS 50MG OF D-MANNITOL AND WFI TO Q.S) + 1 DISPOSABLE SYRINGE, 2 NEEDLES AND 2 ALCOHOL SWABS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 VIAL CARTON + 1*1 ML AMPOULE OF 0.9%W/V NACL

ORAL SOLID ORDINARY TABLETS ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY COATED TABLETS PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE

Page 794: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 ML CARTRIDGE

1.0X3.0 ML PREFILLED PEN

1.0X10.0 ML VIAL

1.0X150.0 MG VIAL ,1X10ML VIAL OF WFI

1.0X5.0 ML VIAL,1.0X0.5 ML VIAL

1.0X5.0 ML VIAL,1.0X0.5 ML VIAL

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X1.0X5.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE,1.0X3.0 ML VIAL

PARENTERAL ORDINARY CARTRIDGES

PARENTERAL ORDINARY PRE-FILLED PENS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES

PARENTERAL ORDINARY DRY VIALS

1.0X440.0 MG VIAL ,1X2X10ML VIALS OF WFI

PARENTERAL ORDINARY AMPOULES

1.0X20.0X10.0 ML AMPOULE,1.0X24.0X10.0 ML AMPOULE,1.0X5.0 ML AMPOULE,1.0X0.5 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 795: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X1.0 TABLET BLISTER

1.0X60.0 ML BLISTER

1.0X6.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X5.0 SUPPOSITORY BLISTER

1.0X5.0 SUPPOSITORY BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X5.0 SUPPOSITORY STRIP

1.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY VIALS

1.0X24.0X10.0 ML VIAL,1.0X35.0X1.0 ML VIAL

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY I M AMPOULES

1.0X24.0X5.0 ML AMPOULE,1.0X48.0X0.5 ML AMPOULE

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

RECTAL SYSTEMIC ADULT SUPPOSITORIES

RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES

ORAL SOLID ORDINARY TABLETS

RECTAL SYSTEMIC ADULT SUPPOSITORIES

VAGINAL SUPPOSITORIES

Page 796: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 SUPPOSITORY STRIP

1.0X6.0 TABLET BLISTER

1.0X10.0X2.0X6.0 TABLET BLISTER

1.0X10.0X3.0X8.0 TABLET BLISTER

1.0X1.0X5.0 SUPPOSITORY BLISTER

1.0X1.0X5.0 SUPPOSITORY BLISTER

1.0X2.0X5.0 SUPPOSITORY STRIP

1.0X5.0 SUPPOSITORY BLISTER

1.0X2.0X5.0 SUPPOSITORY BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

RECTAL SYSTEMIC SUPPOSITORIES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X6.0 TABLET BLISTER,1.0X2.0X6.0 TABLET BLISTER

RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

RECTAL SYSTEMIC ADULT SUPPOSITORIES

RECTAL SYSTEMIC ADULT SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

1.0X1.0X5.0 SUPPOSITORY BLISTER,1.0X2.0X5.0 SUPPOSITORY BLISTER

RECTAL SYSTEMIC SUPPOSITORIES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 797: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X80.0 ML BOTTLE

VAGINAL TABLETS 1.0X5.0 PESSARY BLISTER

VAGINAL TABLETS 1.0X5.0 PESSARY STRIP

VAGINAL TABLETS 1.0X2.0X7.0 PESSARY STRIP

1.0X10.0X9.0 TABLET BLISTER

1.0X1.0X15.0 ML BOTTLE

1.0X6.0 SUPPOSITORY STRIP

10.0X10.0 TABLET STRIP

10.0X10.0X2.0 TABLET STRIP

10.0X10.0 TABLET STRIP

1.0X1.0 TABLET STRIP

1.0X5.0X2.0X10.0 TABLET BLISTER

1.0X10.0X20.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X10.0 G TUBE

1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

RECTAL SYSTEMIC SUPPOSITORIES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS TOPICAL EXTERNAL CREAMS ORAL LIQUID ORDINARY SUSPENSIONS ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X10.0X12.0 TABLET STRIP

Page 798: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0 G TUBE

1.0X10.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE,1.0X10.0 G TUBE

1.0X10.0X3.0 ML AMPOULE

1.0X50.0X5.0 ML VIAL

1.0X5.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X30.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL GELS AND SOLS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

OPHTHALMIC SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

Page 799: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X14.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0X4.0 TABLET STRIP

1.0X4.0X5.0X10.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X15.0 ML BOTTLE

1.0X1.0X3.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

Page 800: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

1.0X60.0 ML BOTTLE

1.0X30.0 ML BOTTLE

1.0X3.0X8.0 TABLET BLISTER

1.0X2.0X12.0 CAPSULE BLISTER

1.0X6.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0X30.0 ML BOTTLE

1.0X1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 801: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0X1.0X7.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X60.0X4.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X3.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID RETARD TABLETS

Page 802: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0 TABLET BLISTER

1.0X4.0X7.0 CAPSULE BLISTER

1.0X2.0 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X7.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X10.0X7.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X7.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X20.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,2.0X10.0 CAPSULE BLISTER

Page 803: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0 ML PRE- FILLED SYRINGE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0 VIAL CARTON

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER ,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

Page 804: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0 TABLET BLISTER

10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE STRIP

1.0X1.0 CANNISTER CARTON

1.0X200.0 METERED DOSE CANNISTER

1.0X1.0 CANNISTER CARTON

1.0X120.0 METERED DOSE CANNISTER

1.0X2.0 ML AMPOULE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID RETARD CAPSULES

LUNG ADMINISTRATION METERED-DOSE INHALER

PARENTERAL ORDINARY VIALS

1.0X1.0 VIAL CARTON ,1X1ML AMPOULE OF WFI

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

PARENTERAL ORDINARY AMPOULES

1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE

LUNG ADMINISTRATION METERED-DOSE INHALER

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 805: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X20.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0 ML VIAL

1.0X1.0 G VIAL

1.0X1000.0 MG VIAL

1.0X30.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X1.0X14.0 TABLET BLISTER

1.0X10.0X1.0 ML AMPOULE

1.0X1.0X10.0 TABLET STRIP

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

Page 806: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0 ML VIAL

1.0X200.0 ML BOTTLE

1.0X1.0 G VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0 ML AMPOULE

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X1.0X10.0 TABLET BLISTER

1.0X2.0 G VIAL

1.0X0.2 ML PRE- FILLED SYRINGE

1.0X30.0 CAPSULE CONTAINER

1.0X5.0 G TUBE,1.0X3.5 G TUBE

1.0X40.0 G TUBE,1.0X20.0 G TUBE

1.0X10.0 G TUBE

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

1.0X5.0X2.0 ML AMPOULE,1.0X5.0X4.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL RETARD I M PRE-FILLED SYRINGES

ORAL SOLID ORDINARY OTHER CAPSULES

1.0X10.0 CAPSULE BLISTER,1.0X20.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

OPHTHALMIC OINTMENTS

ORAL TOPICAL GELS AND SOLS

ORAL TOPICAL GELS AND SOLS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

Page 807: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X20.0 G TUBE,1.0X10.0 G TUBE

1.0X30.0 G TUBE

NASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0 G TUBE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0X5.0 G TUBE

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL OTHER GELS/SOLS

ORAL LIQUID ORDINARY SYRUPS

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET STRIP

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

OPHTHALMIC OINTMENTS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X50.0X4.0 TABLET STRIP

Page 808: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

NASAL TOPICAL DROPS 1.0X10.0 ML VIAL

1.0X30.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X3.5 G TUBE

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0 ML AMPOULE

1.0X1.0 TABLET BLISTER

1.0X1.0 TABLET BLISTER

1.0X30.0X6.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X170.0 ML BOTTLE

ORAL LIQUID ORDINARY LIQUIDS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE

OPHTHALMIC OINTMENTS

TOPICAL EXTERNAL CREAMS

1.0X15.0 G TUBE,1.0X20.0 G TUBE,1.0X10.0 G TUBE

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0 TABLET BOTTLE,1.0X500.0 TABLET BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X1.0X4.0 TABLET BLISTER,1.0X7.0X4.0 TABLET BLISTER,1.0X15.0X4.0 TABLET BLISTER

Page 809: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X200.0 METERED DOSE CANNISTER

1.0X60.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X40.0 CAPSULE CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X140.0 METERED DOSE BOTTLE

1.0X20.0 G TUBE

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X12.0X4.0 TABLET STRIP,1.0X4.0X4.0 TABLET STRIP

ORAL LIQUID ORDINARY LIQUIDS

1.0X100.0 ML BOTTLE,1.0X240.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

1.0X1.0X24.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER

NASAL TOPICAL SPRAYS WITHOUT GAS ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X12.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

Page 810: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X120.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X5.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X5.0X1.0X4.0 CAPSULE BLISTER

1.0X60.0 TABLET BOTTLE

1.0X3.0 TABLET BLISTER

1.0X500.0 TABLET CONTAINER

1.0X3.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY LAYERED TABLETS ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 811: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X200.0 METERED DOSE CANNISTER

1.0X100.0 MG VIAL

1.0X100.0 ML BOTTLE

1.0X200.0 METERED DOSE CANNISTER

4.0X5.0X2.5 ML VIAL

1.0X30.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X2.0 TABLET BLISTER

1.0X2.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X120.0 METERED DOSE CANNISTER

1.0X1.0X1.0 TABLET BLISTER

NASAL SYSTEMIC METERED-DOSE LIQUIDS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY LIQUIDS

LUNG ADMINISTRATION METERED-DOSE INHALER

1.0X1.0X200.0 METERED DOSE CANNISTER

NASAL TOPICAL METERED DOSE AEROSOLS

ORAL SOLID ORDINARY TABLETS

1.0X30.0 TABLET BOTTLE,1.0X60.0 TABLET BOTTLE

LUNG ADMINISTRATION LIQUID FOR INHALATION

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

LUNG ADMINISTRATION METERED-DOSE INHALER

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE

Page 812: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 TABLET BOTTLE

1.0X2.0X0.4 ML PRE- FILLED SYRINGE

1.0X10.0X1.0X3.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

1.0X120.0 METERED DOSE CANNISTER

1.0X50.0 MG VIAL

5.0X2.0 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X15.0 G TUBE

1.0X60.0 TABLET CONTAINER

1.0X30.0 ML BOTTLE

1.0X60.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY PRE-FILLED SYRINGES ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY SOLUBLE TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

PARENTERAL ORDINARY VIALS PARENTERAL ORDINARY DRY VIALS

ORAL SOLID RETARD TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

Page 813: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X1.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0 ML BOTTLE

1.0X10.0 G TUBE,1.0X5.0 G TUBE

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL LIQUID ORDINARY SUSPENSIONS TOPICAL EXTERNAL CREAMS ORAL SOLID ORDINARY OTHER COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X6.0X10.0 TABLET BLISTER,1.0X60.0 TABLET BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 814: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X30.0 TABLET BOTTLE

1.0X30.0 ML BOTTLE

1.0X10.0X10.0X3.0 ML VIAL

1.0X10.0X10.0X2.0 ML AMPOULE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

1.0X20.0 ML VIAL,1.0X30.0 ML VIAL

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X100.0 ML BOTTLE

1.0X20.0 G TUBE

1.0X60.0 ML BOTTLE

1.0X50.0X100.0 MG VIAL

1.0X10.0X10.0X1.0 ML AMPOULE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X100.0X1.0 ML AMPOULE

1.0X10.0 ML BOTTLE

1.0X10.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL GELS AND SOLS

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL LIQUID ORDINARY DROPS

ORAL LIQUID ORDINARY DROPS

Page 815: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X50.0X1.0 G VIAL

1.0X100.0X1.0 ML AMPOULE

1.0X100.0X2.0 ML AMPOULE

OTIC DROPS 1.0X10.0 ML VIAL

1.0X10.0X10.0X1.0 ML AMPOULE

1.0X10.0X10.0X2.0 ML AMPOULE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X1.0X10.0 ML VIAL

1.0X25.0X1.0 G VIAL

1.0X6.0X1.0 ML AMPOULE

1.0X10.0 ML VIAL

1.0X100.0 ML VIAL

ORAL LIQUID ORDINARY LIQUIDS

ORAL LIQUID ORDINARY LIQUIDS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY VIALS PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X100.0 ML BOTTLE,1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML VIAL

Page 816: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 ML VIAL

1.0X25.0X4.0 ML AMPOULE

1.0X50.0 ML VIAL,1.0X20.0 ML VIAL

1.0X20.0 ML VIAL

1.0X5.0X5.0X5.0 ML AMPOULE

1.0X500.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X500.0 ML BOTTLE

1.0X50.0 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION BAGS PARENTERAL ORDINARY VIALS PARENTERAL ORDINARY VIALS

1.0X1.0X50.0 ML VIAL,1.0X5.0X20.0 ML VIAL

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X50.0X2.0 TABLET STRIP,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

Page 817: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X30.0 ML BOTTLE

2.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

VAGINAL TABLETS

1.0X30.0 G TUBE

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

1.0X10.0 TABLET BLISTER ,4*10.3G (SACHETS)

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER

ORAL LIQUID ORDINARY LIQUIDS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

1.0X50.0X14.0 PESSARY STRIP,1.0X14.0 PESSARY STRIP

TOPICAL EXTERNAL OINTMENTS

ORAL LIQUID ORDINARY SOLUBLE POWDERS

1.0X100.0X20.6 G SACHET,1.0X100.0X10.3 G SACHET

ORAL SOLID ORDINARY FILM-COATED TABLETS

10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

Page 818: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

10.0X10.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

Page 819: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

2.0X14.0 TABLET STRIP

1.0X3.0 TABLET BLISTER

1.0X15.0 ML BOTTLE,1.0X30.0 ML BOTTLE

1.0X25.0X4.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

2.0X14.0 TABLET STRIP

1.0X1.0X6.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0X500.0 MG VIAL

1.0X50.0 VIAL CARTON

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS TOPICAL EXTERNAL LIQUIDS

1.0X500.0 ML BOTTLE,1.0X1.0 L JERRYCAN,1.0X5.0 L JERRYCAN

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 820: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 MU VIAL

1.0X10.0X500.0 MG VIAL

1.0X2.4 MU VIAL

1.0X4.0 MU VIAL

1.0X2.4 MU VIAL

1.0X10.0 VIAL CARTON

1.0X10.0 VIAL CARTON

1.0X10.0X500.0 MG VIAL

1.0X50.0 VIAL CARTON

1.0X1.0 G VIAL

1.0X5.0X1.0X10.0 VIAL CARTON

1.0X1000.0 TABLET CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X100.0 TABLET CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X100.0 TABLET BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X50.0X1.0 MU VIAL,1.0X10.0X1.0 MU VIAL

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

500.0 TABLET CONTAINER,1.0X10.0X3.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

Page 821: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X14.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET STRIP

1.0X4.0X14.0 CAPSULE BLISTER

1.0X1.0X7.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

Page 822: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X5.0 SUPPOSITORY STRIP

1.0X2.0X6.0 CAPSULE BLISTER

1.0X2.0X5.0 SUPPOSITORY BLISTER

1.0X2.0X5.0 SUPPOSITORY BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BOTTLE

1.0X1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL ADULT SUPPOSITORIES

ORAL SOLID ORDINARY CAPSULES

RECTAL SYSTEMIC SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 823: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X7.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X70.0 ML BOTTLE

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X14.0 CAPSULE BLISTER

1.0X2.0X14.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X2.0X7.0 TABLET BLISTER

1.0X70.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X15.0 G TUBE

1.0X1.0X100.0 ML BOTTLE

1.0X30.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X20.0 G TUBE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY GELATIN-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY GRANULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL CREAMS ORAL LIQUID ORDINARY SYRUPS ORAL LIQUID ORDINARY SUSPENSIONS TOPICAL EXTERNAL CREAMS ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

TOPICAL EXTERNAL OINTMENTS

Page 824: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

50.0X2.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X20.0 G TUBE

1.0X15.0 G TUBE

1.0X60.0 ML BOTTLE

1.0X2.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

1.0X100.0 TABLET CARTON

1.0X1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL LIQUID ORDINARY SYRUPS TOPICAL EXTERNAL OINTMENTS ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SUSPENSIONS ORAL SOLID ORDINARY TABLETS ORAL LIQUID ORDINARY SUSPENSIONS ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

Page 825: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X20.0 G TUBE

1.0X2.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0X10.0 SUPPOSITORY BLISTER

1.0X1.0X10.0 SUPPOSITORY STRIP

1.0X1.0X10.0 SUPPOSITORY STRIP

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL CREAMS ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY CAPSULES ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY CAPSULES ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SUSPENSIONS ORAL LIQUID ORDINARY SUSPENSIONS RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

RECTAL SYSTEMIC ADULT SUPPOSITORIES

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X250.0 ML BOTTLE

Page 826: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

10.0X3.0 ML VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET CARTON,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X20.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CONTAINER

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

10.0X10.0 TABLET BLISTER + 1 * 10 SAMPLE

ORAL SOLID ORDINARY TABLETS

1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 827: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X25.0 TABLET BLISTER

VAGINAL TABLETS 1.0X6.0 PESSARY CARTON

1.0X10.0X1.0 ML AMPOULE

1.0X1.0X3.0 TABLET BLISTER

ORAL SOLID RETARD TABLETS

10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X15.0 TABLET BLISTER,1.0X8.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,2.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 828: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0 TABLET BLISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X1.0X3.0 TABLET BLISTER

1.0X1.0 G VIAL

1.0X9.0X10.0 TABLET BLISTER

1.0X9.0X10.0 TABLET BLISTER

1.0X10.0X5.0 ML VIAL

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X125.0 ML BOTTLE

1.0X125.0 ML BOTTLE

1.0X20.0 TABLET BLISTER

1.0X5.0 G TUBE

1.0X5.0 G TUBE

5.0X1.0 ML VIAL

ORAL SOLID ORDINARY TABLETS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

OPHTHALMIC OINTMENTS

OPHTHALMIC OINTMENTS

PARENTERAL ORDINARY AMPOULES

Page 829: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 G TUBE

1.0X30.0 G TUBE

1.0X30.0 G TUBE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X15.0 G TUBE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X1.0X5.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY S C VIALS

1.0X4.0 ML VIAL,1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X6.0 TABLET BLISTER,1.0X1.0X3.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

1.0X3.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 830: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

2.0X10.0 TABLET STRIP

1.0X5.0 CAPSULE BLISTER

1.0X30.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X1000.0 MG VIAL

1.0X1000.0 MG VIAL

1.0X5.0 ML AMPOULE

1.0X10.0 TABLET BLISTER

1.0X1.0 VIAL CARTON

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0 ML PRE- FILLED SYRINGE

1.0X4.0 ML VIAL

1.0X16.0 ML VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SUSPENSIONS PARENTERAL ORDINARY DRY VIALS PARENTERAL ORDINARY DRY VIALS PARENTERAL ORDINARY AMPOULES ORAL SOLID ORDINARY FILM-COATED TABLETS PARENTERAL ORDINARY INFUSION DRY VIALS/BOTTLES

1.0X440.0 MG VIAL ,2OML VIAL OF SOLVENT

PARENTERAL ORDINARY DRY VIALS ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

Page 831: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0X10.0 ML SACHET

1.0X150.0 ML BOTTLE

1.0X4.0 TABLET BLISTER

1.0X20.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X27.9 G SACHET

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X1.0X5.0 ML BOTTLE

1.0X75.0 G CONTAINER

1.0X100.0 G CONTAINER

OPHTHALMIC VIALS 1.0X5.0 ML VIAL,1.0X10.0 ML VIAL

1.0X5.0X2.0 TABLET BLISTER

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X10.0X1.0X3.0 TABLET BLISTER

1.0X80.0 ML BOTTLE

1.0X5.0X4.0 ML VIAL

1.0X6.0X10.0 ML SACHET

ORAL LIQUID ORDINARY LIQUIDS

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

TOPICAL EXTERNAL POWDERS

TOPICAL EXTERNAL POWDERS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY LIQUIDS

PARENTERAL RETARD I M AMPOULES ORAL LIQUID ORDINARY LIQUIDS

Page 832: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X15.0 CAPSULE BLISTER

1.0X30.0 G TUBE

1.0X20.0 G TUBE

1.0X5.0X1.0 ML VIAL

TABLET STRIP, AMPOULE AMPOULE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X30.0 CAPSULE BLISTER

1.0X200.0 ML BOTTLE

PARENTERAL ORDINARY DRY PRE-FILLED PENS

1.0X3.0 ML AMPOULE + 1 *2ML CLEAR GLASS AMPOULES FOR SOLVENT

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY DRY VIALS

10.0X4.0 ML VIAL 10*1ML CLEAR COLOURLESS GLASS AMPOULES CONTAINING 9.0MG/ML OF NACL

PARENTERAL ORDINARY VIALS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY LIQUIDS

Page 833: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X500.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X1000.0 TABLET CONTAINER

1.0X20.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X1.0X2.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL TOPICAL GELS AND SOLS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER, 1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER, 1.0X1000.0 TABLET CONTAINER

Page 834: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0X25.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X50.0 ML VIAL

1.0X10.0X10.0 ML VIAL

1.0X10.0X20.0 ML VIAL

1.0X500.0 ML BAG

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY OTHER INFUSIONS

1.0X10.0X20.0 ML VIAL,1.0X10.0X50.0 ML VIAL,1.0X10.0X100.0 ML VIAL

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY INFUSION BAGS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 835: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X2.0 ML AMPOULE

1.0X5.0X10.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X10.0X5.0 ML AMPOULE

1.0X20.0 G CONTAINER

1.0X10.0 G TUBE

ORAL TOPICAL LIQUIDS

1.0X15.0 G TUBE,1.0X20.0 G TUBE

1.0X500.0 ML BOTTLE

1.0X30.0 G TUBE

1.0X20.0 G TUBE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL OINTMENTS

1.0X15.0 G TUBE,1.0X125.0 G TUBE,1.0X250.0 G JAR

TOPICAL EXTERNAL LIQUIDS

1.0X100.0 ML BOTTLE,1.0X500.0 ML BOTTLE,1.0X50.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL LIQUIDS

ORAL TOPICAL GELS AND SOLS

TOPICAL EXTERNAL CREAMS

Page 836: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 G TUBE

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X15.0 G TUBE

1.0X5.0 G TUBE

1.0X3.5 G TUBE,1.0X5.0 G TUBE

1.0X5.0 G TUBE

1.0X25.0 G TUBE,1.0X500.0 G TUBE

1.0X15.0 G TUBE

1.0X1.0X30.0 G TUBE

1.0X40.0 G TUBE,1.0X800.0 G CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X200.0 ML BOTTLE

1.0X1.0 ML VIAL 1*20ML VIAL OF WFI

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL EMULSIONS

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X1000.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS OPHTHALMIC OINTMENTS OPHTHALMIC OINTMENTS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL LOTIONS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY DRY VIALS

Page 837: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 G TUBE

1.0X4.0X5.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X2.0X5.0X10.0 TABLET BLISTER

1.0X2.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X100.0 ML BOTTLE

1.0X5.0X5.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X2.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

TOPICAL EXTERNAL OINTMENTS ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES PARENTERAL ORDINARY AMPOULES PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 838: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X2.0 ML VIAL

1.0X1.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X5.0X1.0 ML AMPOULE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X5.0X2.0 ML AMPOULE

1.0X100.0 AMPOULE CARTON

1.0X10.0X2.0 ML AMPOULE

1.0X30.0 TABLET CONTAINER

1.0X3.0 G TUBE,1.0X15.0 G TUBE

1.0X1.0X15.0 G TUBE

1.0X120.0 METERED DOSE CANNISTER

1.0X1.0 CANNISTER CARTON

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY AMPOULES PARENTERAL ORDINARY AMPOULES PARENTERAL ORDINARY AMPOULES PARENTERAL ORDINARY AMPOULES ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X30.0 TABLET CONTAINER,1.0X3.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

NASAL TOPICAL SPRAYS WITHOUT GAS

LUNG ADMINISTRATION METERED-DOSE POWDER INHALER

Page 839: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 DOSE CANNISTER

1.0X7.0 SACHET CARTON

1.0X30.0 TABLET CONTAINER

1.0X100.0X20.0 DOSE VIAL

1.0X0.5 ML VIAL

1.0X2.0 ML AMPOULE

1.0X100.0 ML BOTTLE

1.0X30.0 G TUBE

1.0X30.0 G TUBE

1.0X2.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN

1.0X30.0 TABLET BOTTLE

LUNG ADMINISTRATION METERED-DOSE POWDER INHALER

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES

1.0X8.0X4.5 G SACHET,1.0X10.0X4.5 G SACHET,1.0X48.0X4.5 G SACHET

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

1.0X2.5 ML AMPOULE,1.0X5.0 ML AMPOULE,1.0X10.0 ML AMPOULE

ORAL LIQUID ORDINARY SYRUPS

1.0X150.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS TOPICAL EXTERNAL OINTMENTS ORAL LIQUID ORDINARY SUSPENSIONS

1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X50.0 TABLET CARTON,1.0X10.0 TABLET CARTON,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X2.0 L JERRYCAN

ORAL SOLID RETARD CAPSULES

1.0X2.0X10.0 CAPSULE BLISTER,1.0X1.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 840: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0 CAPSULE BLISTER

1.0X100.0 METERED DOSE CANNISTER

10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X12.0 SACHET CARTON

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0 CANNISTER CARTON

1.0X60.0 METERED DOSE CANNISTER

1.0X60.0 METERED DOSE CANNISTER

1.0X120.0 METERED DOSE CANNISTER

1.0X60.0 ML CANNISTER

1.0X28.0 TABLET BLISTER

1.0X28.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET BLISTER,1.0X12.0 TABLET BLISTER,1.0X96.0 TABLET BLISTER,1.0X480.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE,1.0X2.0 L BOTTLE

RECTAL SYSTEMIC METERED-DOSE PRESSURISED AEROSOLS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

LUNG ADMINISTRATION METERED-DOSE POWDER INHALER

LUNG ADMINISTRATION METERED-DOSE POWDER INHALER

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

LUNG ADMINISTRATION METERED-DOSE POWDER INHALER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 841: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X12.0 TABLET BLISTER

1.0X1.0X12.0 TABLET BLISTER

1.0X120.0 METERED DOSE CANNISTER

1.0X120.0 METERED DOSE CANNISTER

1.0X28.0 TABLET BLISTER

1.0X750.0 MG VIAL

1.0X120.0 METERED DOSE CANNISTER

1.0X1.0 DOSE PRE- FILLED SYRINGE

1.0X1.0 ML VIAL

1.0X0.5 ML VIAL

1.0X1.5 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

PARENTERAL ORDINARY VIALS

1.0X10.0 VIAL CARTON,1.0X25.0 VIAL CARTON

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY COMBINATION PACK VIALS

PARENTERAL ORDINARY VIALS

1.0X10.0 VIAL CARTON,1.0X25.0 VIAL CARTON

ORAL LIQUID ORDINARY LIQUIDS

Page 842: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X25.0 G TUBE,1.0X30.0 G TUBE

1.0X30.0 G TUBE,1.0X25.0 G TUBE

1.0X30.0 G TUBE,1.0X15.0 G TUBE

1.0X30.0 G TUBE,1.0X15.0 G TUBE

1.0X1.0 G VIAL

1.0X1.0 VIAL CARTON

1.0X1.0 G VIAL

1.0X1.0 VIAL CARTON

1.0X1.0 VIAL CARTON

PARENTERAL ORDINARY PRE-FILLED SYRINGES

1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE + A 25 GAUGE NEEDLE

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X20.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY LOZENGES

1.0X150.0 TABLET CARTON,1.0X100.0 TABLET CARTON,1.0X50.0 TABLET CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X20.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY LOZENGES

1.0X150.0 TABLET AMPOULE,1.0X100.0 TABLET AMPOULE,1.0X50.0 TABLET AMPOULE

ORAL SOLID ORDINARY TABLETS

1.0X11.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

PARENTERAL ORDINARY VIALS PARENTERAL ORDINARY DRY VIALS PARENTERAL ORDINARY DRY VIALS PARENTERAL ORDINARY DRY VIALS PARENTERAL ORDINARY VIALS

Page 843: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

2.5 ML VIAL,1.0X10.0 ML VIAL

1.0X1.0 TABLET BLISTER

1.0X1.0X50.0 ML BOTTLE

1.0X1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X1.0X50.0 ML BOTTLE

1.0X10.0 G TUBE

1.0X120.0 METERED DOSE CANNISTER

1.0X120.0 METERED DOSE CANNISTER

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY VIALS ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER,1.0X50.0 TABLET CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

TOPICAL EXTERNAL OINTMENTS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

Page 844: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X14.0 TABLET BOTTLE

1.0X120.0 METERED DOSE CANNISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X200.0 METERED DOSE CANNISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

LUNG ADMINISTRATION METERED-DOSE INHALER

LUNG ADMINISTRATION METERED-DOSE INHALER

LUNG ADMINISTRATION METERED-DOSE INHALER

Page 845: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X200.0 METERED DOSE CANNISTER

1.0X200.0 METERED DOSE CANNISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X150.0 ML BOTTLE

1.0X10.0 G TUBE

1.0X3.0X10.0 TABLET BLISTER

VAGINAL TABLETS 1.0X6.0 PESSARY STRIP

VAGINAL GELS AND SOLS 1.0X30.0 G TUBE

LUNG ADMINISTRATION METERED-DOSE INHALER

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

Page 846: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0X4.0 TABLET STRIP

60.0 ML BOTTLE

1.0X4.0 CAPSULE STRIP

1.0X15.0 G TUBE

1.0X5.0 G TUBE,1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X15.0 ML BOTTLE

1.0X20.0 G TUBE

1.0X5.0X5.0 TABLET BLISTER

1.0X15.0 G TUBE

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL LIQUID SOAPS/WASHES

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL OTHER OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL LOTIONS

TOPICAL EXTERNAL CREAMS ORAL SOLID ORDINARY TABLETS TOPICAL EXTERNAL GELS AND SOLS ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

1.0X1.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP

Page 847: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 G BOTTLE,1.0X30.0 G BOTTLE

1.0X15.0 G TUBE

1.0X15.0 G TUBE

VAGINAL TABLETS 1.0X1.0 PESSARY STRIP

ORAL TOPICAL LIQUIDS 1.0X15.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X150.0 METERED DOSE BOTTLE

1.0X120.0 METERED DOSE BOTTLE

1.0X20.0 G TUBE

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X150.0 ML BOTTLE

1.0X2.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY LIQUIDS

1.0X180.0 ML BOTTLE,1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL DUSTING POWDERS TOPICAL EXTERNAL CREAMS TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SYRUPS ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

NASAL TOPICAL METERED DOSE AEROSOLS

NASAL SYSTEMIC METERED-DOSE LIQUIDS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0 CAPSULE BLISTER,1.0X2.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0X6.0 TABLET BLISTER, AMPOULE AMPOULE

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

Page 848: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X150.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X100.0X2.0 ML AMPOULE

ML VIAL, ML AMPOULE

ML VIAL, ML AMPOULE

1.0X10.0 CAPSULE BLISTER

1.0X1.0 G VIAL + 10 ML AMPOULE WFI

1.0X2.0X3.0 TABLET BLISTER

1.0X2.0X3.0 TABLET BLISTER

1.0X5.0 TABLET BLISTER

1.0X6.0X1.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY INFUSION AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X9.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X30.0 MG VIAL + 1*0.5 ML SODIUM BICARBONATE

Page 849: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X3.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0X3.0X20.0 TABLET BLISTER

1.0X1.0X3.0X20.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X5.0X5.0 ML AMPOULE

1.0X750.0 MG VIAL

PARENTERAL ORDINARY DRY VIALS

1.0X120.0 MG VIAL + 1 *2 ML AMPOULE OF 5% SODIUM BICARBONATE SOLUTION + 1*10 ML AMPOULE OF 0.9% SODIUM CHLORIDE

PARENTERAL ORDINARY DRY VIALS

1.0X60.0 MG VIAL + 1*5% NAHCO3 + 5 ML NACL INJECTION

ORAL SOLID ORDINARY OTHER TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X20.0X3.0 TABLET BLISTER,1.0X20.0X6.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

PARENTERAL ORDINARY INFUSION AMPOULES

PARENTERAL ORDINARY DRY VIALS

Page 850: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X20.0 TABLET BLISTER

1.0X200.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X120.0 ML BOTTLE

1.0X14.0 CAPSULE BOTTLE

1.0X2.0X12.0 TABLET BLISTER

1.0X30.0 G TUBE

1.0X30.0 G TUBE

1.0X15.0 G TUBE

1.0X20.0 G TUBE

1.0X2.0X9.0 LOZENGE BLISTER

1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 851: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X1.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0 TABLET BLISTER

1.0X1.0 ML AMPOULE

1.0X1.0 ML AMPOULE

1.0X1.0 ML VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X30.0 ML BOTTLE,1.0X15.0 ML BOTTLE

1.0X1.0X1.5 G VIAL

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 VIAL CARTON + 5 ML AMPOULE OF WATER FOR INJECTION

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL RETARD AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X3.0 TABLET BLISTER,1.0X2.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

RECTAL SYSTEMIC ADULT SUPPOSITORIES

10.0X1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X5.0 SUPPOSITORY STRIP

Page 852: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X6.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 TABLET CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X120.0 TABLET CONTAINER

1.0X1.0 G VIAL

1.0X200.0 MG VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

Page 853: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 854: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 855: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 856: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X240.0 ML BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X240.0 ML BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 857: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0 TABLET BLISTER

1.0X120.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 858: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET CONTAINER

1.0X120.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

Page 859: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X10.0 CAPSULE BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X12.0 CAPSULE BLISTER

1.0X12.0 CAPSULE BLISTER

1.0X5.0 CAPSULE STRIP

1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE

1.0X10.0X5.0 ML AMPOULE

1.0X10.0 CAPSULE BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X2.0X10.0 CAPSULE BLISTER

1.0X120.0 ML BOTTLE

1.0X10.0X5.0 ML AMPOULE

1.0X2.0X6.0 CAPSULE STRIP

1.0X10.0X10.0 CAPSULE BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0 ML AMPOULE

1.0X250.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY COATED TABLETS ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY CAPSULES ORAL LIQUID ORDINARY SUSPENSIONS PARENTERAL ORDINARY AMPOULES ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY CAPSULES ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

2.0X5.0 TABLET BLISTER,1.0X5.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

PARENTERAL ORDINARY AMPOULES PARENTERAL ORDINARY INFUSION VIALS/BOTTLES ORAL SOLID RETARD FILM-COATED TABLETS

Page 860: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X12.0 TABLET BLISTER

1.0X30.0 G CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X3.0 TABLET BLISTER

1.0X120.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X4.0 CAPSULE BLISTER

1.0X15.0 G TUBE

5.0X5.0 TABLET BLISTER

1.0X5.0 G TUBE

1.0X4.0 TABLET BLISTER

1.0X7.0X4.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X5.0X20.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X3.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS TOPICAL EXTERNAL LIQUID SOAPS/WASHES ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY CAPSULES TOPICAL EXTERNAL CREAMS ORAL SOLID ORDINARY TABLETS TOPICAL EXTERNAL CREAMS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY CAPSULES

ORAL SOLID RETARD TABLETS

Page 861: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X6.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X1.0 ML VIAL

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X7.0 TABLET BLISTER

1.0X150.0 ML BOTTLE

1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY OTHER COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS ORAL SOLID RETARD TABLETS PARENTERAL ORDINARY DRY VIALS

1.0X1.0 I.U VIAL 1*0.5ML DILUENT ( 0.9%W/V SODIUM CHLORIDE INJ. B.P)

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 862: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X6.0 TABLET BLISTER

1.0X4.0X10.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X20.0 G TUBE,1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X20.0 G TUBE

ORAL TOPICAL LIQUIDS 1.0X100.0 ML BOTTLE

1.0X15.0 ML BOTTLE

1.0X10.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL CREAMS TOPICAL EXTERNAL CREAMS TOPICAL EXTERNAL CREAMS ORAL LIQUID ORDINARY SYRUPS ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

1.0X2.0X5.0X10.0 BLISTER BLISTER,1.0X5.0X5.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS ORAL LIQUID ORDINARY SUSPENSIONS ORAL SOLID ORDINARY TABLETS

1.0X5.0X200.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X1.0X100.0 ML BOTTLE,1.0X1.0X200.0 ML BOTTLE

Page 863: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X120.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X1.0X6.0 TABLET BLISTER

1.0X10.0X1.0X6.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X10.0X1.0X7.0 TABLET BLISTER

1.0X10.0X2.0X7.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS ORAL LIQUID ORDINARY SUSPENSIONS ORAL SOLID ORDINARY TABLETS

1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID RETARD TABLETS ORAL SOLID RETARD TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID RETARD FILM-COATED TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 864: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X10.0 TABLET BLISTER

1.0X1.0X30.0 ML BOTTLE

1.0X1.0 G VIAL + 10 ML VIAL WFI

1.0X10.0 ML VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

PARENTERAL ORDINARY DRY VIALS PARENTERAL ORDINARY VIALS ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

2.0X2.0X7.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 865: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

20.0X5.0X2.0 ML AMPOULE

1.0X7.0X6.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X2.0X10.0 TABLET BLISTER, AMPOULE AMPOULE, TABLET BLISTER, AMPOULE AMPOULE

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 866: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X5.0X10.0 CAPSULE STRIP

1.0X3.0X10.0 CAPSULE BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X30.0 ML VIAL

1.0X5.0X20.0 TABLET BLISTER

1.0X5.0X20.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY CAPSULES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

1.0X2.0X14.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS PARENTERAL ORDINARY VIALS

ORAL SOLID RETARD TABLETS

ORAL SOLID RETARD TABLETS

Page 867: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE STRIP

1.0X5.0X3.0 TABLET BLISTER

1.0X10.0X1.0X6.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X3.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X5.0X2.0 TABLET STRIP,1.0X7.0X3.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

1.0X7.0X3.0 TABLET STRIP,1.0X5.0X2.0 TABLET STRIP

ORAL SOLID ORDINARY SOLUBLE TABLETS

PARENTERAL ORDINARY I M AMPOULES

1.0X6.0X1.0 ML AMPOULE,1.0X8.0X1.0 ML AMPOULE

PARENTERAL ORDINARY DRY VIALS

1.0X60.0 MG VIAL + 1*5 ML SODIUM CHLORIDE INJECTION + 1*1 ML AMPOULE OF SODIUM BICARBONATE INJECTION

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

Page 868: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X6.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X500.0 ML BOTTLE

1.0X500.0 ML BOTTLE

1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

OPHTHALMIC SUSPENSIONS

Page 869: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

5.0 ML VIAL

1.0X1.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 5.0 ML BOTTLE

NASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE,1.0X10.0 ML BOTTLE

OPHTHALMIC SUSPENSIONS

PARENTERAL ORDINARY VIALS

Page 870: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

NASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE

OPHTHALMIC DROPS

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

OPHTHALMIC DROPS 5.0 ML VIAL,10.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE

OTIC DROPS 1.0X5.0 ML BOTTLE,1.0X10.0 ML BOTTLE

NASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE

1.0X30.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

5.0 ML BOTTLE,10.0 ML BOTTLE,7.5 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X5.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

Page 871: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

3.0X7.0 CAPSULE BLISTER

1.0X1.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X240.0 TABLET BOTTLE

1.0X480.0 TABLET BOTTLE

1.0X5.0X1.0 ML AMPOULE

1.0X5.0X1.0 ML AMPOULE

1.0X3.0 OVULE BLISTER

1.0X120.0 TABLET BOTTLE

1.0X120.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

VAGINAL SUPPOSITORIES ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY TABLETS ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X20.0 TABLET CARTON,1.0X30.0 TABLET CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

Page 872: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0X2.0 ML AMPOULE

10.0X10.0X3.0 ML VIAL

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X6.0X1.0 ML AMPOULE

1.0X9.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER, AMPOULE AMPOULE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY I M AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

Page 873: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0X3.0 ML VIAL

1.0X10.0X10.0 CAPSULE BLISTER

1.0X1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET STRIP

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY LIQUIDS

1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER

ORAL LIQUID ORDINARY OTHER LIQUIDS

1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE

ORAL LIQUID ORDINARY LIQUIDS

1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE,1.0X2.5 L BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

ORAL LIQUID ORDINARY LIQUIDS

1.0X250.0 ML CONTAINER,1.0X500.0 ML CONTAINER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY LIQUIDS

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X6.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

Page 874: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0 PREFILLED SYRINGE CARTON

1.0X1.0 VIAL CARTON

1.0X100.0 ML BOTTLE

100.0 ML BOTTLE,60.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY I V AMPOULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0 CAPSULE STRIP,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER, 1.0X100.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

1000.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER

Page 875: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,100.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X100.0 TABLET CARTON,1.0X10.0 TABLET CARTON

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,250.0 TABLET CONTAINER

Page 876: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY LIQUIDS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X100.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION

ORAL SOLID ORDINARY CAPSULES

500.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X100.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER,1.0X250.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

Page 877: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 CAPSULE BLISTER

1.0X15.0X10.0 TABLET BLISTER

100.0 ML BOTTLE

1.0X50.0X4.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID RETARD CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

100.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,10.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET JAR,1.0X500.0 TABLET JAR,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY OTHER COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

Page 878: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

100.0 CAPSULE CONTAINER,1000.0 CAPSULE CONTAINER,250.0 CAPSULE CONTAINER,500.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE CONTAINER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1000.0 TABLET CONTAINER,500.0 TABLET CONTAINER,10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,100.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

Page 879: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X60.0 ML BOTTLE

10.0X10.0 TABLET BLISTER

1.0X100.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE STRIP

1.0X30.0 G TUBE,1.0X15.0 G TUBE

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CARTON,1.0X250.0 TABLET CONTAINER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL OINTMENTS

PARENTERAL ORDINARY DRY VIALS

1.0X10.0X500.0 MG VIAL,1.0X50.0X500.0 MG VIAL

Page 880: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0X1.0 G VIAL,1.0X50.0X1.0 G VIAL

1.0X10.0X500.0 MG VIAL

1.0X10.0X500.0 MG VIAL

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X16.0X14.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X10.0X100.0 MG VIAL,1.0X50.0X100.0 MG VIAL

PARENTERAL ORDINARY AMPOULES

1.0X10.0X2.0 ML AMPOULE, 1.0X100.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 881: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X100.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 AMPOULE AMPOULE,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

Page 882: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 ML BOTTLE

1.0X15.0 G TUBE,1.0X5.0 G TUBE

1.0X20.0 G TUBE

1.0X120.0 ML BOTTLE

1.0X5.0 G TUBE,1.0X15.0 G TUBE

1.0X90.0 ML BOTTLE

1.0X120.0 ML BOTTLE

1.0X15.0 G TUBE

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL CREAMS

Page 883: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 ML VIAL

1.0X10.0 CAPSULE BLISTER

1.0X15.0 G TUBE,1.0X5.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X5.0 G TUBE,1.0X15.0 G TUBE

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X100.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X90.0 ML BOTTLE,1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

Page 884: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 ML BOTTLE

1.0X1.0 G VIAL

1.0X1.0 G VIAL

1.0X500.0 MG VIAL

1.0X1.0 G VIAL

1.0X5.0 G TUBE,1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X20.0 G TUBE

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0X10.0 TABLET BLISTER,500.0 TABLET CONTAINER,1000.0 TABLET CONTAINER,250.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

Page 885: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X25.0 G TUBE

1.0X15.0 G TUBE

1.0X20.0 G TUBE

1.0X30.0 G TUBE

1.0X25.0 G TUBE

1.0X1.0X25.0 G TUBE

1.0X1.0X30.0 G TUBE

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

1.0X30.0 G TUBE,1.0X15.0 G TUBE,1.0X25.0 G TUBE

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

Page 886: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 G TUBE

1.0X200.0 ML BOTTLE

1.0X3.0X4.0 TABLET BLISTER

1.0X2.0X10.0 CAPSULE BLISTER

1.0X16.0 SACHET CARTON

1.0X30.0 SACHET CARTON

VAGINAL TABLETS 1.0X15.0 PESSARY STRIP

VAGINAL TABLETS 1.0X1.0X6.0 PESSARY STRIP

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES

ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES

ORAL SOLID ORDINARY TABLETS

1.0X20.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

Page 887: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X100.0 ML BOTTLE

1.0X1.0X15.0 G TUBE

1.0X1.0X100.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

1.0X15.0 G TUBE

1.0X1.0X15.0 G TUBE

TOPICAL EXTERNAL CREAMS

1.0X1.0X15.0 G TUBE,1.0X1.0X20.0 G TUBE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X1.0X6.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X280.0 CAPSULE CONTAINER,1.0X100.0 CAPSULE CONTAINER

TOPICAL EXTERNAL OINTMENTS

Page 888: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G TUBE

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X200.0 TABLET CONTAINER,1.0X25.0X3.0 TABLET BLISTER,1.0X3.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

TOPICAL EXTERNAL GELS AND SOLS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

Page 889: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET BLISTER

1.0X20.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X1.0X1000.0 MG VIAL

1.0X15.0 G TUBE

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

2.0X50.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X20.0 TABLET BLISTER

TOPICAL EXTERNAL OINTMENTS

Page 890: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X20.0X3.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X20.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY OTHER CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

Page 891: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X170.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X20.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE STRIP

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

Page 892: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X30.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X1.0X4.0 TABLET BLISTER

1.0X2.0X10.0X10.0 TABLET BLISTER

1.0X30.0 G TUBE,1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 893: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X170.0 ML BOTTLE

1.0X70.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X8.0 CAPSULE BLISTER

1.0X2.0X15.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 894: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X4.0X25.0 TABLET BLISTER

1.0X4.0X15.0 TABLET BLISTER

1.0X6.0X10.0 TABLET BLISTER

1.0X4.0X25.0 TABLET BLISTER

1.0X9.0X10.0 TABLET BLISTER

1.0X9.0X10.0 TABLET BLISTER

1.0X9.0X10.0 TABLET BLISTER

1.0X9.0X10.0 TABLET BLISTER

1.0X0.5 ML VIAL

1.0X2.0X12.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY I M VIALS

ORAL SOLID ORDINARY TABLETS

Page 895: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X120.0 ML BOTTLE

1.0X3.0 ML VIAL,1.0X5.0 ML VIAL

1.0X10.0 ML VIAL

1.0X10.0X1.0 ML VIAL, ML BLISTER

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X90.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X5.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X60.0 MG VIAL + 1*1 ML AMPOULE OF 5.0%W/V SODIUM BICARBONATE INJECTION B.P + 1*5 ML AMPOULE OF 0.9%W/V NACL

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY I M AMPOULES

1.0X2.0X3.0X1.0 ML AMPOULE,1.0X1.0X6.0 ML AMPOULE

Page 896: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0X100.0 MG VIAL

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X10.0 TABLET STRIP

1.0X10.0 G TUBE

1.0X10.0X1.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X10.0X10.0 TABLET STRIP,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

Page 897: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X15.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X1.0X10.0 CAPSULE BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY COMBINATION PACK TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X5.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)

Page 898: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X2.0 TABLET BLISTER

1.0X25.0X4.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X1.0X12.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD LAYERED TABLETS

Page 899: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X50.0X1.0X4.0 TABLET STRIP

1.0X20.0 G TUBE,1.0X125.0 G TUBE

1.0X15.0 G TUBE

1.0X10.0X6.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X3.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

2.0X3.0X1.0 ML AMPOULE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID RETARD FILM-COATED TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY I M AMPOULES

Page 900: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 G TUBE

1.0X20.0 G CONTAINER

1.0X15.0 G CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X1.0 L BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,1.0X100.0X1.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL LIQUIDS

Page 901: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

10.0X10.0 TABLET BLISTER

VAGINAL TABLETS 1.0X6.0 TABLET STRIP

1.0X15.0 G TUBE

1.0X10.0X5.0X10.0 ML AMPOULE

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X1.0X1.0 TABLET BLISTER

1.0X10.0X1.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY TABLETS

Page 902: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X20.0 G TUBE,1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BOTTLE

OPHTHALMIC DROPS 1.0X6.0X2.5 ML BOTTLE

1.0X1.0X6.0 TABLET BLISTER

1.0X75.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X25.0X3.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL TOPICAL GELS AND SOLS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY EFFERVESCENT TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 903: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 ML VIAL

1.0X1.0 G VIAL

1.0X500.0 MG VIAL

1.0X10.0 ML VIAL

1.0X10.0 ML VIAL

1.0X10.0 ML VIAL

1.0X10.0X10.0 TABLET STRIP

1.0X0.5 G VIAL

1.0X10.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY S C VIALS

ORAL SOLID ORDINARY CAPSULES

1.0X5.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 904: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 ML AMPOULE

1.0X1000.0 MG VIAL

1.0X10.0X10.0X10.0 ML AMPOULE

1.0X1.0 G VIAL

1.0X30.0 TABLET BOTTLE

1.0X3.0 TABLET BLISTER

1.0X15.0X1.0X4.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

Page 905: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0 VIAL CARTON

1.0X10.0X10.0 CAPSULE STRIP

1.0X30.0 TABLET BOTTLE

1.0X10.0X10.0 TABLET STRIP

1.0X50.0X1000.0 MG VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X6.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY SOLUBLE TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

Page 906: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X24.0X28.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,3.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

1.0X10.0X6.0 TABLET BLISTER,1.0X24.0X28.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

Page 907: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET BOTTLE

1.0X120.0 TABLET BOTTLE

1.0X20.0X5.0 TABLET BLISTER

1.0X20.0X5.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X3.0X28.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X8.0 TABLET BLISTER,1.0X1.0X6.0 TABLET BLISTER,1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X1.0X12.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X30.0X6.0 TABLET ORAL LIQUID ORDINARY

SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY GELATIN-COATED TABLETS

Page 908: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET STRIP

1.0X60.0 TABLET BOTTLE

1.0X1000.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X5.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X100.0 TABLET CONTAINER,1.0X3.0X28.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 909: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0X1.0 G VIAL

1.0X30.0X4.0 G SACHET

1.0X30.0 TABLET BOTTLE

1.0X5.0X6.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID RETARD GRANULES

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET STRIP,3.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS

Page 910: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X4.0X2.0 ML AMPOULE

1.0X4.0 TABLET BLISTER

1.0X50.0 ML BOTTLE

1.0X1.5 G VIAL

1.0X25.0X3.0 TABLET BLISTER

1.0X25.0X3.0 TABLET BLISTER

1.0X1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY LIQUIDS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY LAYERED TABLETS

1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER,1.0X6.0 TABLET BLISTER

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY TABLETS

Page 911: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X250.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X125.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL LIQUIDS

TOPICAL EXTERNAL LIQUIDS

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL LIQUIDS

TOPICAL EXTERNAL SUSPENSIONS

TOPICAL EXTERNAL LIQUIDS

ORAL SOLID ORDINARY TABLETS

Page 912: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X15.0 CAPSULE BLISTER

1.0X10.0X1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

VAGINAL TABLETS 1.0X14.0 PESSARY STRIP

1.0X1.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X200.0 ML BOTTLE,1.0X90.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 913: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X5.0X4.0 TABLET BLISTER

1.0X20.0 G TUBE

VAGINAL CREAMS 1.0X20.0 G TUBE

1.0X6.0 SUPPOSITORY STRIP

1.0X120.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X15.0 G TUBE,1.0X30.0 G TUBE

1.0X30.0 ML BOTTLE

TOPICAL EXTERNAL OTHER CREAMS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL TOPICAL GELS AND SOLS

TOPICAL EXTERNAL SUPPOSITORIES

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL GELS AND SOLS

ORAL LIQUID ORDINARY LIQUIDS

Page 914: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 VIAL CARTON

1.0X120.0 ML BOTTLE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X120.0 ML BOTTLE

1.0X150.0 ML CANNISTER

3.0X1.0 ML AMPOULE

1.0X7.0 TABLET BLISTER

1.0X30.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL PRESSURISED AEROSOLS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY SOLUBLE TABLETS

Page 915: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 TABLET CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X1000.0 CAPSULE CONTAINER

1.0X100.0X20.5 G SACHET

1.0X1000.0 TABLET CONTAINER

1.0X100.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 916: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.4 G SACHET

1.0X1.0 G VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SOLUBLE POWDERS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X7.0X1.0X6.0 TABLET BLISTER (BLISTER CONTAINS 2 CAPSULES AND 4 TABLETS)

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DROPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 917: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE STRIP

1.0X100.0 ML BOTTLE

1.0X10.0X20.0 TABLET STRIP

1.0X9.0X10.0 TABLET STRIP

1.0X10.0X15.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID RETARD ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

Page 918: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 VIAL CARTON

1.0X10.0 VIAL CARTON

1.0X10.0X1.0 G VIAL

1.0X5.0 TABLET BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0 G VIAL + 10 ML AMPOULE WFI

1.0X3.0X10.0 TABLET BLISTER

1.0X500.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X200.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 919: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML CONTAINER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X70.0 ML BOTTLE

1.0X2.0X7.0 TABLET BLISTER

1.0X2.0X6.0 TABLET BLISTER

1.0X2.0X6.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

Page 920: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X100.0 TABLET BLISTER

1.0X70.0 ML BOTTLE

1.0X2.0X7.0 TABLET BLISTER

1.0X70.0 ML BOTTLE

1.0X2.0X7.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X3.0X10.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP,1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

Page 921: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X7.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X2.0X7.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X200.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

Page 922: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X20.0 ML BOTTLE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0 TABLET BLISTER

1.0X8.0 ML BOTTLE

1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY OTHER CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X1.0X10.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY CAPSULES

25.0X20.0 CAPSULE BLISTER,10.0X10.0 CAPSULE BLISTER,1.0X500.0 CAPSULE CONTAINER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 923: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X70.0 ML BOTTLE

1.0X1.0X100.0 ML BOTTLE

1.0X3.0X10.0 CAPSULE BLISTER

1.0X6.0X5.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

Page 924: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

6.0X1.0X10.0 CAPSULE BLISTER

1.0X5.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY OTHER CAPSULES

ORAL SOLID ORDINARY OTHER CAPSULES

ORAL SOLID ORDINARY OTHER CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID RETARD TABLETS

Page 925: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 TABLET BLISTER

1.0X6.0 TABLET BLISTER

1.0X20.0 G TUBE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X6.0X15.0 TABLET BLISTER

1.0X4.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X30.0 TABLET BLISTER,1.0X4.0X25.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD TABLETS

ORAL SOLID RETARD TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X4.0X25.0 TABLET BLISTER,1.0X1.0X30.0 TABLET BLISTER

Page 926: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X4.0X15.0 TABLET BLISTER

1.0X4.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X15.0 TABLET BLISTER,1.0X4.0X15.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X500.0 TABLET CONTAINER,1.0X6.0X15.0 TABLET BLISTER,1.0X30.0 TABLET BLISTER

PARENTERAL ORDINARY PRE-FILLED PENS

1.0X1.0 ML AMPOULE WITH 5 NEEDLES FOR ADMINSTRATION

PARENTERAL ORDINARY CARTRIDGES

1.0X1.0 CARTRIDGE PREFILLED PEN + 7 NEEDLES FOR ADMINSTRATION

Page 927: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 ML VIAL + 1*1ML VIAL OF WFI

1.0X1.0 PREFILLED SYRINGE CARTON

1.0X30.0 TABLET CONTAINER

1.0X180.0 CAPSULE BOTTLE

1.0X5.0X2.0 ML AMPOULE

NASAL TOPICAL DROPS 1.0X1.0X10.0 ML BOTTLE

1.0X2.0X10.0 CAPSULE BLISTER

1.0X1.0X5.0X2.0 ML AMPOULE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY PRE-FILLED PENS

1.0X1.0 CARTRIDGE PREFILLED PEN + 8 NEEDLES FOR ADMINSTRATION

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 VIAL CARTON + 1 PRE FILLED SYRINGE OF WFI

PARENTERAL ORDINARY PRE-FILLED SYRINGES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY AMPOULES

Page 928: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 ML BOTTLE

1.0X50.0 G TUBE,1.0X20.0 G TUBE

1.0X1.0X6.0 SUPPOSITORY STRIP

1.0X2.0X5.0 SUPPOSITORY STRIP

1.0X2.0X5.0 SUPPOSITORY STRIP

1.0X2.0X5.0 SUPPOSITORY STRIP

1.0X5.0 SUPPOSITORY STRIP

1.0X10.0 ML BOTTLE

1.0X100.0 ML BOTTLE

NASAL TOPICAL SPRAYS WITHOUT GAS

TOPICAL EXTERNAL GELS AND SOLS

RECTAL SYSTEMIC SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

RECTAL SYSTEMIC ADULT SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

RECTAL SYSTEMIC SUPPOSITORIES

ORAL LIQUID ORDINARY EMULSIONS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

1.0X10.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE

ORAL LIQUID ORDINARY SYRUPS

Page 929: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X7.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X5.0X10.0 TABLET BLISTER

1.0X10.0 CAPSULE BLISTER

1.0X1.0 G VIAL + 1*10ML (WFI) LDPE VIAL

1.0X10.0 CAPSULE BLISTER

1.0X10.0 TABLET STRIP

1.0X1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X6.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X30.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 930: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X500.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X6.0 TABLET STRIP,1.0X2.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X3.0X10.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 931: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X500.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 932: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

10.0X10.0 TABLET BLISTER

1.0X500.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

Page 933: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET STRIP

1.0X1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 934: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X5.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X20.0X5.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X20.0 ML VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

Page 935: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X3.0X4.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY OTHER TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE,1.0X200.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

Page 936: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY SOLUBLE TABLETS

1.0X10.0X10.0 TABLET BLISTER ,1.0X2.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER, 1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

Page 937: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X35.0 G TUBE

1.0X20.0 G TUBE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X200.0 ML BOTTLE

1.0X3.0 G SACHET

1.0X10.0 ML VIAL

1.0X25.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS

1.0X10.0 TABLET BLISTER, 1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SOLUBLE POWDERS

PARENTERAL ORDINARY VIALS

ORAL SOLID RETARD TABLETS

ORAL SOLID RETARD FILM-COATED TABLETS

Page 938: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X25.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY SUBLINGUAL TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 939: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X120.0 ML BOTTLE

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

NASAL SYSTEMIC METERED-DOSE LIQUIDS

1.0X1.0X120.0 METERED DOSE CANNISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 940: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 941: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X5.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X2.0X2.0 TABLET BLISTER

1.0X2.0X2.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 942: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL TOPICAL LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X125.0 ML BOTTLE,1.0X250.0 ML BOTTLE

TOPICAL EXTERNAL WASH/SHOWER GELS

1.0X125.0 ML BOTTLE,1.0X500.0 ML BOTTLE

Page 943: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X40.0 G TUBE

1.0X1.0X250.0 ML BOTTLE

1.0X4.5 G VIAL

1.0X30.0 TABLET BOTTLE

1.0X2.0 TABLET BLISTER

1.0X1.0 TABLET BLISTER

1.0X3.0X28.0 TABLET BLISTER

TOPICAL EXTERNAL WASH/SHOWER GELS

1.0X500.0 ML BOTTLE,1.0X120.0 ML BOTTLE

TOPICAL EXTERNAL OINTMENTS

VAGINAL LIQUID EMULSIONS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 944: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X28.0 TABLET BLISTER

1.0X3.0X28.0 TABLET BLISTER

1.0X28.0 TABLET BLISTER

1.0X3.0X28.0 TABLET BLISTER

1.0X1.0X2.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 945: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X28.0 TABLET BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 946: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X12.0 TABLET BLISTER

1.0X6.0X3.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X120.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X30.0 CAPSULE CONTAINER,1.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0 CAPSULE BLISTER,1.0X30.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0 CAPSULE BLISTER, CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X120.0 TABLET CONTAINER,1.0X30.0 TABLET BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 947: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X60.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X120.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X30.0 TABLET CONTAINER

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET BOTTLE,1.0X1.0X30.0 TABLET BOTTLE

ORAL SOLID ORDINARY TABLETS

Page 948: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 TABLET CONTAINER

1.0X60.0 TABLET BOTTLE

1.0X60.0 TABLET BOTTLE

1.0X68.0 MG IMPLANT

1.0X100.0X1.0X28.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X2.0 TABLET BLISTER

VAGINAL TABLETS 1.0X1.0 TABLET STRIP

1.0X135.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL RETARD IMPLANTS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

RECTAL SYSTEMIC ENEMA LIQUIDS

Page 949: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X120.0 ML BOTTLE

1.0X40.0 G TUBE + 1 APPLICATOR

1.0X3.0 G TUBE WITH STERILE CATHETER

1.0X1.0X6.0 CAPSULE BLISTER

1.0X1.0X15.0 ML BOTTLE

1.0X1.0X80.0 G TUBE

1.0X15.0 G TUBE

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

Page 950: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0 ML VIAL

1.0X20.0 ML VIAL

1.0X5.0 ML VIAL

1.0X10.0 ML VIAL

1.0X1.0X20.0 ML VIAL

1.0X5.0 ML VIAL

1.0X5.0 ML VIAL

1.0X10.0 TABLET BOTTLE

1.0X50.0 MG VIAL

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

1.0X10.0 ML VIAL + 1*6ML SOLVENT FOR RECONSTITUTION

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY OTHER VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

Page 951: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X200.0 MG VIAL

1.0X200.0 MG VIAL

1.0X10.0 ML VIAL

1.0X10.0 ML VIAL

1.0X10.0X10.0 CAPSULE BLISTER

1.0X1.0 G VIAL

1.0X10.0X2.0 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X250.0 ML BOTTLE,1.0X355.0 ML AMPOULE

Page 952: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET STRIP

1.0X750.0 MG VIAL + 10ML WFI AMPOULE

1.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X355.0 ML BOTTLE,1.0X250.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X1.0X1.0 G VIAL + 1*10 ML WATER FOR INJECTION

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

1.0X1.0X1.0 G VIAL + 1*10 ML WFI AMPOULE

ORAL SOLID ORDINARY TABLETS

Page 953: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G CONTAINER

1.0X24.0 G CONTAINER

1.0X20.0X3.5 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X20.0X3.5 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL OINTMENTS

OPHTHALMIC OINTMENTS

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

OPHTHALMIC OINTMENTS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 954: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X3.0 G TUBE,1.0X15.0 G TUBE

1.0X20.0 G TUBE

1.0X15.0 G TUBE

1.0X200.0 G TUBE,1.0X15.0 G TUBE

1.0X30.0 G TUBE,1.0X20.0 G TUBE

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL GELS AND SOLS

Page 955: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X15.0 G TUBE

1.0X20.0 G TUBE

1.0X3.0 G TUBE,1.0X15.0 G TUBE

1.0X18.0 G TUBE

1.0X20.0 G TUBE

1.0X25.0 G TUBE

1.0X1.0 G VIAL

1.0X2.0X5.0X1.0 ML AMPOULE

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY I V AMPOULES

PARENTERAL ORDINARY I V AMPOULES

Page 956: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 ML AMPOULE

1.0X2.0X5.0X1.0 ML AMPOULE

1.0X20.0 ML VIAL

1.0X1.0 G VIAL

1.0X10.0 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0 ML VIAL

1.0X2.0X5.0X1.0 ML AMPOULE

1.0X5.0X2.0 ML AMPOULE

1.0X1.0X20.0 ML VIAL

PARENTERAL ORDINARY I V AMPOULES

PARENTERAL ORDINARY I V AMPOULES

PARENTERAL RETARD OTHER VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY OTHER VIALS

PARENTERAL ORDINARY I V AMPOULES

PARENTERAL ORDINARY S C AMPOULES

PARENTERAL ORDINARY DRY VIALS

Page 957: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 ML VIAL

1.0X1.0 G VIAL

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X1.0 ML VIAL

1.0X10.0X1.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X10.0X2.0 ML VIAL

1.0X10.0X1.0 ML AMPOULE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 958: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X10.0X3.0 ML AMPOULE

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X50.0X10.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X100.0X2.0 ML AMPOULE

1.0X2.0 ML AMPOULE

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

1.0X10.0X2.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 959: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X10.0X2.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

OTIC DROPS 1.0X10.0 ML VIAL

1.0X6.0X1.0 ML AMPOULE

1.0X50.0X10.0 ML AMPOULE

1.0X25.0X1.0X2.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X1.0X10.0 ML VIAL

1.0X10.0X5.0X2.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I M AMPOULES

Page 960: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0X2.0 ML AMPOULE

1.0X100.0 ML BOTTLE

1.0X1.0X5.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X12.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X5.0 TABLET BLISTER,1.0X1.0 TABLET BLISTER,1.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X300.0 TABLET CONTAINER,1.0X60.0 TABLET CONTAINER,1.0X4.0X15.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X6.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 961: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET BLISTER

1.0X30.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X6.0 TABLET BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X20.0 G TUBE,1.0X50.0 G TUBE

1.0X20.0 G TUBE

NASAL SYSTEMIC DROPS 1.0X10.0 ML BOTTLE

NASAL TOPICAL DROPS 1.0X10.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL GELS AND SOLS

Page 962: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET CONTAINER

1.0X15.0 G TUBE

1.0X30.0 G TUBE

NASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE

1.0X5.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X1.0X28.0 TABLET STRIP

1.0X1.0X14.0 TABLET BLISTER

1.0X30.0 TABLET CONTAINER

ORAL SOLID ORDINARY EFFERVESCENT TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

ORAL SOLID RETARD TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X14.0 TABLET BLISTER,1.0X2.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID RETARD TABLETS

Page 963: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET CONTAINER

1.0X50.0 TABLET CONTAINER

1.0X2.0X14.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X1.0 VIAL CARTON

1.0X3.0X10.0 TABLET BLISTER

1.0X5.0X6.0 TABLET BLISTER

1.0X5.0X1.0 ML VIAL

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY COATED TABLETS

10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY COATED TABLETS

1.0X100.0 TABLET CONTAINER,1.0X20.0 TABLET CONTAINER

ORAL LIQUID ORDINARY DROPS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

PARENTERAL ORDINARY AMPOULES

Page 964: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 CAPSULE BLISTER

1.0X4.0X14.0 TABLET BLISTER

1.0X4.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X4.0X14.0 TABLET BLISTER

1.0X5.0X6.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

LUNG ADMINISTRATION INHALER CAPSULES

1.0X1.0 CANNISTER CARTON + 30 CAPSULE BLISTER

LUNG ADMINISTRATION INHALER CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 965: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X14.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X3.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X7.0X4.0 CAPSULE BLISTER

1.0X4.0X7.0 TABLET BLISTER

1.0X10.0X1.0 ML AMPOULE

1.0X4.0X14.0 TABLET BLISTER

1.0X4.0X14.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 966: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X12.0X10.0 TABLET BLISTER

1.0X12.0X10.0 TABLET BLISTER

1.0X1.0X28.0 TABLET STRIP

1.0X20.0 G TUBE

1.0X5.0X3.0 ML PREFILLED PEN

1.0X5.0X3.0 ML PREFILLED PEN

1.0X5.0X3.0 ML PREFILLED PEN

1.0X10.0 ML VIAL

1.0X10.0 ML VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY DRY PRE-FILLED PENS

PARENTERAL ORDINARY PRE-FILLED PENS

PARENTERAL ORDINARY CARTRIDGES

1.0X1.5 ML PIPETTE,1.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY PRE-FILLED PENS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY S C VIALS

Page 967: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 ML VIAL

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X1.0 G VIAL

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X6.0 TABLET BLISTER

1.0X10.0 ML AMPOULE

PARENTERAL ORDINARY PRE-FILLED PENS

1.0X1.5 ML CARTRIDGE,1.0X3.0 ML CARTRIDGE

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY PRE-FILLED PENS

1.0X1.5 ML PREFILLED PEN,1.0X3.0 ML PREFILLED PEN

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X500.0 ML BOTTLE,1.0X250.0 ML BOTTLE

PARENTERAL ORDINARY AMPOULES

Page 968: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X500.0 ML BAG

1.0X500.0 ML BAG

1.0X1.0 CANNISTER CARTON

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X250.0 ML BOTTLE,1.0X500.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION BAGS

PARENTERAL ORDINARY INFUSION BAGS

LUNG ADMINISTRATION CFC-FREE METERED-DOSE INHALER

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

Page 969: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 CAPSULE BLISTER

1.0X90.0 G CONTAINER

1.0X30.0 G TUBE

1.0X5.0X2.0X10.0 TABLET BLISTER

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X10.0 ML VIAL,1.0X1.0 ML VIAL

1.0X30.0 TABLET BOTTLE

1.0X30.0 TABLET BOTTLE

1.0X1.0X30.0 TABLET BOTTLE

1.0X28.0 TABLET BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SOLUBLE POWDERS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES

PARENTERAL ORDINARY I M VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 970: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 TABLET CONTAINER

1.0X60.0 TABLET CONTAINER

1.0X1.0X60.0 TABLET BOTTLE

1.0X1.0X60.0 TABLET BOTTLE

1.0X25.0 ML BOTTLE

1.0X1.0X30.0 TABLET BOTTLE

1.0X2.0X8.0 TABLET BLISTER

1.0X10.0 SUPPOSITORY BLISTER

1.0X25.0 G TUBE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID RETARD ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

TOPICAL EXTERNAL LOTIONS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

1.0X12.0X3.0 G SACHET,1.0X8.0X3.0 G SACHET

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL SUPPOSITORIES

TOPICAL EXTERNAL OINTMENTS

Page 971: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X14.0 CAPSULE BLISTER

1.0X2.0X14.0 CAPSULE BLISTER

1.0X2.0X14.0 CAPSULE BLISTER

1.0X5.0 ML AMPOULE

1.0X28.0 TABLET BLISTER

1.0X28.0 TABLET BLISTER

1.0X200.0X0.65 ML PRE- FILLED SYRINGE

1.0X4.0 ML VIAL,1.0X2.0 ML VIAL

1.0X2.0 ML VIAL,1.0X8.0 ML VIAL

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

1.0X1.0 ML VIAL,1.0X2.0 ML VIAL,1.0X5.0 ML VIAL

Page 972: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X2.5 ML BOTTLE

1.0X7.0 CAPSULE BLISTER

1.0X1.0 CAPSULE BLISTER

OPHTHALMIC LIQUIDS

1.0X1.0X6.0 CAPSULE BLISTER

1.0X15.0 ML BOTTLE

1.0X120.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X4.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X12.0 TABLET BLISTER,1.0X8.0 TABLET BLISTER,1.0X4.0 TABLET BLISTER

1.0X10.0 ML BOTTLE,1.0X5.0 ML BOTTLE,1.0X4.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

1.0X100.0 CAPSULE CARTON,1.0X2.0X8.0 CAPSULE STRIP

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

Page 973: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X6.5 G SACHET

1.0X100.0 ML BOTTLE

1.0X60.0 ML BOTTLE

ORAL TOPICAL LIQUIDS 1.0X120.0 ML BOTTLE

1.0X2.0X10.0 TABLET BLISTER

1.0X3.0 CAPSULE BLISTER

VAGINAL CREAMS 1.0X40.0 G TUBE

1.0X120.0 ML BOTTLE

1.0X120.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY EFFERVESCENT POWDERS/GRANULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

VAGINAL SUPPOSITORIES

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

Page 974: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X10.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X2.0X10.0 CAPSULE BLISTER

1.0X20.0 G TUBE

1.0X20.0 G TUBE

1.0X5.0 SUPPOSITORY STRIP

1.0X120.0 ML BOTTLE

1.0X2.0X12.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL CREAMS

ORAL TOPICAL GELS AND SOLS

RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY OTHER CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

Page 975: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X12.0 G TUBE

1.0X5.0 SUPPOSITORY STRIP

1.0X20.0 ML BOTTLE

1.0X10.0 G CONTAINER

1.0X5.0 SUPPOSITORY STRIP

1.0X10.0 ML VIAL

1.0X30.0 CAPSULE BOTTLE

1.0X50.0 ML VIAL,1.0X10.0 ML VIAL

1.0X12.0 TABLET STRIP

TOPICAL EXTERNAL CREAMS

RECTAL SYSTEMIC PAEDIATRIC SUPPOSITORIES

TOPICAL EXTERNAL LIQUIDS

TOPICAL EXTERNAL POWDERS

RECTAL SYSTEMIC ADULT SUPPOSITORIES

PARENTERAL ORDINARY OTHER VIALS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X8.0 CAPSULE STRIP,1.0X100.0 CAPSULE CARTON

Page 976: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X80.0 ML BOTTLE

1.0X30.0 ML BOTTLE

1.0X3.5 ML VIAL,1.0X1.0 ML VIAL

VAGINAL TABLETS 1.0X4.0 TABLET STRIP

1.0X100.0X1.8 ML CARTRIDGE

50.0 G CONTAINER,100.0 G CONTAINER

1.0X15.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY OTHER POWDERS/GRANULES

TOPICAL EXTERNAL LIQUIDS

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY CARTRIDGES

TOPICAL EXTERNAL OTHER GELS/SOLS

TOPICAL EXTERNAL LIQUIDS

TOPICAL EXTERNAL GELS AND SOLS

ORAL SOLID ORDINARY TABLETS

1.0X25.0 TABLET BLISTER,1.0X28.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

Page 977: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X7.0 CAPSULE STRIP

1.0X14.0 CAPSULE BOTTLE

1.0X1000.0 MG VIAL

1.0X500.0 MG VIAL

2.0 ML AMPOULE

1.0X10.0 G CONTAINER

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

1.0X28.0 TABLET BOTTLE,1.0X25.0 TABLET BOTTLE

TOPICAL EXTERNAL POWDERS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 978: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X200.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

1.0X1000.0 MG VIAL + 5 ML AMPOULE OF WATER FOR INJECTION

ORAL SOLID ORDINARY TABLETS

1.0X20.0 TABLET BLISTER,10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1.0X100.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 979: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X3.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X20.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 980: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET BLISTER

1.0X2.0X14.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

1.0X60.0 MG VIAL + 1*5 ML OF 0.9% W/V NACL GLASS AMPOULE + 1*1 ML OF 5%W/V NAHCO3 GLASS AMPOULE

PARENTERAL ORDINARY I V AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY LAYERED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 981: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X3.5 G TUBE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X5.0X20.0 ML AMPOULE

1.0X10.0X5.0 ML AMPOULE

1.0X10.0X10.0 CAPSULE STRIP

1.0X500.0 ML BOTTLE

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL LIQUID ORDINARY LIQUIDS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

OPHTHALMIC OINTMENTS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

PARENTERAL ORDINARY I V AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

1.0X1.0 VIAL CARTON + 1 AMPOULE OF SOLVENT

ORAL SOLID ORDINARY OTHER CAPSULES

PARENTERAL ORDINARY INFUSION BAGS

Page 982: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 ML BOTTLE

1.0X6.0 VIAL CARTON

1.0X0.5 G VIAL

1.0X1.0 G VIAL

1.0X1.0 G VIAL

1.0X25.0X4.0 TABLET STRIP

1.0X5.0X10.0 CAPSULE BLISTER

PARENTERAL ORDINARY INFUSION BAGS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X125.0 MG VIAL + 1*2ML AMPOULE OF WFI

PARENTERAL ORDINARY DRY VIALS

1.0X500.0 MG VIAL + 1*8ML AMPOULE OF WFI

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1.0X24.0 TABLET BLISTER,1.0X30.0X18.0 TABLET BLISTER,1.0X30.0X24.0 TABLET BLISTER,1.0X30.0X12.0 TABLET BLISTER,1.0X30.0X6.0 TABLET BLISTER,1.0X1.0X18.0 TABLET BLISTER,1.0X1.0X12.0 TABLET ORAL SOLID ORDINARY

OTHER CAPSULES

Page 983: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0X10.0 CAPSULE BLISTER

1.0X5.0 SUPPOSITORY STRIP

1.0X5.0X5.0 ML AMPOULE

1.0X100.0 ML BOTTLE

CAPSULE BLISTER, AMPOULE AMPOULE

1.0X100.0 ML BOTTLE

1.0X188.0 TABLET BOTTLE

ORAL SOLID ORDINARY OTHER CAPSULES

RECTAL SYSTEMIC ADULT SUPPOSITORIES

PARENTERAL ORDINARY I V AMPOULES

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY LOZENGES

1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK

ORAL SOLID ORDINARY LOZENGES

1.0X24.0 LOZENGE PACK,1.0X70.0 LOZENGE PACK

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

Page 984: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X10.0 TABLET BLISTER

1.0X3.0X8.0 CAPSULE BLISTER

1.0X1.0X12.0 CAPSULE BLISTER

1.0X10.0 CAPSULE BLISTER

1.0X60.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN

1.0X12.0 CAPSULE BLISTER

1.0X1.0X25.0 G TUBE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL OINTMENTS

Page 985: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X2.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X1.0X100.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X20.0 G TUBE

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

1.0X500.0 ML BOTTLE,1.0X15.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

Page 986: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X25.0 G TUBE,1.0X400.0 G TUBE

NASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE

NASAL TOPICAL DROPS 1.0X15.0 ML BOTTLE

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X500.0 CAPSULE CONTAINER,1.0X1000.0 CAPSULE CONTAINER,1.0X8.0X12.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X12.0 CAPSULE BLISTER,1.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CHEWABLE TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS

Page 987: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

25.0 G TUBE

100.0 ML BOTTLE,60.0 ML BOTTLE

1.0X1.0X12.0 CAPSULE BLISTER

1.0X15.0 G TUBE

1.0X10.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

TOPICAL EXTERNAL EMULSION GELS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

10.0X10.0 TABLET BLISTER,1.0X20.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL CREAMS

1.0X10.0 G TUBE,1.0X15.0 G TUBE,1.0X5.0 G TUBE

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X250.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

Page 988: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0 PESSARY BLISTER + 1*20G TUBE

1.0X15.0 G TUBE

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

VAGINAL COMBINATION PACK TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER,1.0X50.0X2.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

Page 989: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X25.0 G TUBE

1.0X15.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X15.0 G TUBE

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL OINTMENTS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

1.0X50.0X2.0 TABLET STRIP,1.0X100.0X10.0 TABLET STRIP,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

Page 990: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X25.0 G TUBE

1.0X60.0 ML BOTTLE,1.0X5.0 L JERRYCAN

ORAL TOPICAL LIQUIDS 1.0X250.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X50.0X2.0 TABLET STRIP

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X100.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

Page 991: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

2.0X10.0 TABLET BLISTER

2.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,100.0X10.0 CAPSULE BLISTER

Page 992: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

50.0X2.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

Page 993: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G TUBE

10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 G TUBE

VAGINAL TABLETS 1.0X2.0X3.0 PESSARY STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X28.0 TABLET BLISTER

1.0X2.0X7.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X100.0 TABLET CONTAINER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 994: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

10.0X10.0 CAPSULE BLISTER

3.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X4.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 995: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OTIC DROPS 1.0X10.0 ML BOTTLE

1.0X20.0 G TUBE

OPHTHALMIC DROPS 1.0X7.5 ML VIAL

OPHTHALMIC DROPS 1.0X10.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML VIAL

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

TOPICAL EXTERNAL OINTMENTS

ORAL SOLID ORDINARY CAPSULES

Page 996: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X60.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0 SACHET CARTON

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

1.0X1.0X60.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SOLUBLE POWDERS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

Page 997: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X30.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

Page 998: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1000.0 TABLET CONTAINER

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 CAPSULE CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X3.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 999: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET STRIP

1.0X25.0X4.0 TABLET STRIP

1.0X1000.0 TABLET CONTAINER

30.0X2.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X1000.0 TABLET CONTAINER

1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X20.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

Page 1000: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X1000.0 TABLET CONTAINER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X500.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X3.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

Page 1001: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

3.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X8.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1000.0 TABLET CONTAINER

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1002: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X110.0 ML BOTTLE

10.0X10.0 CAPSULE BLISTER

1.0X50.0X1.0 G VIAL

1.0X50.0X4.0 MU VIAL

1.0X50.0X500.0 MG VIAL

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,10.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 1003: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0 VIAL CARTON

1.0X50.0 VIAL CARTON

1.0X50.0X500.0 MG VIAL

1.0X50.0X2.4 MU VIAL

DOSE AMPOULE, DOSE AMPOULE

1.0X10.0X1.0 G VIAL

1.0X50.0X1.0 G VIAL

ML VIAL

1.0X50.0X1.0 G VIAL

1.0X20.0 ML VIAL

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 1004: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 VIAL CARTON

1.0X50.0 VIAL CARTON

1.0X10.0 VIAL CARTON

1.0X1.0 VIAL CARTON

10.0X10.0X3.0 ML VIAL

1.0X50.0X1.0 MU VIAL

1.0X22.5 ML BOTTLE

1.0X60.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 1005: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0 CAPSULE BLISTER

1.0X2.0X10.0 CAPSULE BLISTER

1.0X6.0X0.3 ML PRE- FILLED SYRINGE

1.0X8.0 ML VIAL

1.0X1.0X10.0X2.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X1.0 ML AMPOULE

10.0 ML VIAL

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY AMPOULES

PARENTERAL ORDINARY AMPOULES

Page 1006: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X1.0 ML AMPOULE

1.0X1.0X1.0 ML AMPOULE

1.0X10.0X1.0 ML AMPOULE

1.0X25.0X20.0 ML VIAL

1.0X1.0 ML AMPOULE

1.0X1.0 ML AMPOULE

1.0X5.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

1.0X3.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY I M AMPOULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1007: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X20.0 G TUBE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X100.0 ML VIAL

1.0X2.0X5.0X2.0 ML AMPOULES

1.0X6.0X1.0 ML AMPOULE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

2.0X6.0X2.0 ML VIAL

RECTAL SYSTEMIC SUPPOSITORIES

1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP

RECTAL SYSTEMIC SUPPOSITORIES

1.0X5.0 SUPPOSITORY STRIP,1.0X2.0X5.0 SUPPOSITORY STRIP

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY I V VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY I M AMPOULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

Page 1008: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0X60.0 ML BOTTLE

1.0X10.0X2.0 ML AMPOULE

1.0X180.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

1.0X2.0X5.0X2.0 ML AMPOULE

1.0X2.0X5.0X2.0 ML AMPOULE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SOLUBLE POWDERS

1.0X1.0X50.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY AMPOULES

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

1.0X2.0X6.0X2.0 ML AMPOULE IN BLISTERS

Page 1009: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X3.2 ML AMPOULE

1.0X2.0X5.0X2.0 ML VIAL

1.0X15.0 ML BOTTLE

1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

ORAL LIQUID ORDINARY DROPS

ORAL LIQUID ORDINARY SYRUPS

Page 1010: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X2.0 ML AMPOULE

1.0X3.0X3.0 ML AMPOULE

1.0X3.0X1.0 ML AMPOULE

2.0X5.0X2.0 ML AMPOULE

1.0X1.0X50.0 ML BOTTLE

1.0X3.0X10.0 TABLET BLISTER

1.0X4.0X25.0 TABLET BLISTER

1.0X15.0 ML VIAL

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

1.0X2.0X5.0X2.0 ML AMPOULE,1.0X100.0X2.0 ML AMPOULE

ORAL LIQUID ORDINARY SOLUBLE POWDERS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

Page 1011: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X1.5 G VIAL

1.0X1.0X10.0 TABLET BLISTER

1.0X10.0 ML VIAL,1.0X50.0X10.0 ML VIAL

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X20.0 ML VIAL

1.0X1.0 VIAL CARTON

1.0X100.0 ML BOTTLE

1.0X1.0 G VIAL

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY DRY VIALS

Page 1012: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X7.0X2.0 TABLET STRIP

1.0X7.0X2.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

1.0X60.0 ML BOTTLE

1.0X2.0X6.0 CAPSULE BLISTER

1.0X1.0 G VIAL

1.0X4.5 ML VIAL

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 1013: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X4.0X25.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X15.0 ML BOTTLE

1.0X3.0 TABLET BLISTER

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X1.0 DOSE VIAL

1.0X1.0 VIAL CARTON

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY I V PRE-FILLED SYRINGES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES

1.0X0.5 ML PRE- FILLED SYRINGE,1.0X0.5 ML VIAL

Page 1014: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 DOSE VIAL

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X0.5 ML VIAL

1.0X1.0 VIAL CARTON

1.0X1.0 VIAL CARTON

1.0X0.5 ML VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X2.0X0.6 ML PRE- FILLED SYRINGE

1.0X2.0X0.8 ML PRE- FILLED SYRINGE

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES

PARENTERAL ORDINARY I M PRE-FILLED SYRINGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I M VIALS

ORAL SOLID ORDINARY COATED TABLETS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

Page 1015: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X0.4 ML PRE- FILLED SYRINGE

1.0X2.0X0.2 ML PRE- FILLED SYRINGE

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0 ML AMPOULE

1.0X1.0X10.0 TABLET BLISTER

1.0X1.0X10.0 TABLET BLISTER

1.0X4.0 ML VIAL

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X100.0 ML BOTTLE,1.0X50.0 ML BOTTLE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY S C VIALS

1.0X10.0 ML VIAL,1.0X3.0 ML PRE- FILLED SYRINGE

PARENTERAL ORDINARY VIALS

1.0X5.0X3.0 ML CARTRIDGE,1.0X5.0 ML VIAL

Page 1016: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0X3.0 ML CARTRIDGE

1.0X5.0 ML VIAL

1.0X10.0 ML VIAL

1.0X5.0X3.0 ML CARTRIDGE

1.0X5.0X3.0 ML PREFILLED PEN

1.0X1.0 ML VIAL

1.0X1.0X21.0 TABLET BLISTER

5.0X6.0 TABLET BLISTER

1.0X30.0 TABLET BOTTLE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY CARTRIDGES

PARENTERAL ORDINARY PRE-FILLED PENS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

1.0X30.0 G CONTAINER,1.0X10.0 G CONTAINER

ORAL SOLID ORDINARY TABLETS

Page 1017: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X7.0 TABLET BLISTER

3.0X10.0 TABLET BLISTER

1.0X30.0 MG TUBE

1.0X15.0 G TUBE

1.0X1.0 G VIAL

1.0X120.0 ML BOTTLE

1.0X4.0X4.0 CAPSULE STRIP

1.0X2.0X10.0 TABLET STRIP

1.0X80.0 ML BOTTLE

1.0X1.0 ML VIAL,1.0X0.5 ML VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL OINTMENTS

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY DRY VIALS

Page 1018: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 VIAL CARTON

1.0X1.0 VIAL CARTON

1.0X1.0 VIAL CARTON

PARENTERAL ORDINARY I M VIALS

1.0X10.0X0.5 ML VIAL,1.0X25.0X5.0 ML VIAL

PARENTERAL ORDINARY PRE-FILLED SYRINGES

1.0X1.0X1.0 ML PRE- FILLED SYRINGE,1.0X1.0X1.0 ML VIAL

PARENTERAL ORDINARY PRE-FILLED SYRINGES

1.0X0.5 ML VIAL,1.0X0.5 ML PRE- FILLED SYRINGE

PARENTERAL ORDINARY AMPOULES

1.0X1.0 VIAL CARTON,1.0X1.0 AMPOULE CARTON

PARENTERAL ORDINARY DRY VIALS

1.0X1.0X10.0 DOSE VIAL + 1*5ML AMPOULE OF DILUENT

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

1.0X1.0 AMPOULE CARTON,1.0X1.0 VIAL CARTON

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY I M VIALS

1.0X50.0X1.0 ML VIAL,1.0X10.0X10.0 ML VIAL

Page 1019: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0X1.0 ML AMPOULE

1.0X6.0X0.5 ML PRE- FILLED SYRINGE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X2.0 ROD IMPLANT

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X100.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

PARENTERAL ORDINARY DRY VIALS

1.0X10.0 VIAL CARTON,1.0X50.0 VIAL CARTON

PARENTERAL RETARD IMPLANTS

Page 1020: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X120.0 ML BOTTLE

1.0X3.0 TABLET BLISTER

1.0X1.0 VIAL CARTON

1.0X1.0 VIAL CARTON

10.0X1.2 G VIAL

PARENTERAL ORDINARY DRY VIALS

1.0X50.0 VIAL CARTON,1.0X10.0 VIAL CARTON

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X2.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X20.0 TABLET PACK,1.0X110.0 TABLET PACK,1.0X100.0 TABLET PACK

ORAL SOLID ORDINARY TABLETS

1.0X20.0 TABLET PACK,1.0X110.0 TABLET PACK,1.0X100.0 TABLET PACK

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X70.0 ML BOTTLE,1.0X100.0 ML BOTTLE

Page 1021: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X1.0X7.0 TABLET BLISTER

1.0X1.0X70.0 ML BOTTLE

1.0X2.0X1.0X7.0 TABLET BLISTER

1.0X10.0X1.2 G VIAL

1.0X10.0X25.0 ML VIAL

1.0X14.0 TABLET BLISTER

1.0X70.0 ML BOTTLE

2.0X10.0 TABLET BLISTER

1.0X10.0X600.0 MG VIAL

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X100.0 ML BOTTLE,1.0X70.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

Page 1022: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 CAPSULE CARTON

1.0X100.0 ML VIAL

1.0X10.0X5.0 TABLET BLISTER

4.0X25.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

1.0X70.0 ML BOTTLE,1.0X140.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X14.0 TABLET STRIP,10.0X10.0 TABLET STRIP,1.0X20.0 TABLET STRIP

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

1.0X8.0X5.0 G SACHET,1.0X48.0X5.0 G SACHET

ORAL LIQUID ORDINARY SOLUBLE POWDERS

1.0X48.0X5.6 G SACHET,1.0X5.0X5.6 G SACHET

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 1023: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X100.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 1024: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0 CAPSULE STRIP

1.0X10.0 CAPSULE STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X10.0 CAPSULE STRIP

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

1.0X100.0X10.0 CAPSULE BLISTER,1.0X1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1025: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 TABLET BLISTER

1.0X15.0 G TUBE

1.0X20.0 G TUBE

1.0X40.0 G TUBE

VAGINAL CREAMS 1.0X40.0 G TUBE

1.0X30.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X80.0 ML BOTTLE

1.0X1.0 TABLET BLISTER

1.0X6.0 BLISTER CARTON

ORAL SOLID ORDINARY CHEWABLE TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

ORAL TOPICAL GELS AND SOLS

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL LIQUID SOAPS/WASHES

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY CAPSULES

Page 1026: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0X6.0 TABLET BLISTER

1.0X50.0 ML BOTTLE

1.0X2.0X6.0 CAPSULE BLISTER

1.0X1.0X6.0 CAPSULE BLISTER

1.0X1.0 G VIAL + 1*10 ML AMPOULE WFI

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 G VIAL + 1*10 ML AMPOULE WATER FOR INJECTION

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID RETARD CAPSULES

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

Page 1027: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 AMPOULE CARTON

1.0X200.0 METERED DOSE CANNISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY SOLUBLE TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY SOLUBLE TABLETS

LUNG ADMINISTRATION LIQUID FOR INHALATION

LUNG ADMINISTRATION METERED-DOSE INHALER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 1028: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X3.0X10.0 TABLET STRIP

1.0X200.0 ML BOTTLE

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 CAPSULE BLISTER

1.0X15.0 ML BOTTLE

1.0X10.0X5.0 G SACHET

1.0X1.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DROPS

ORAL SOLID ORDINARY GRANULES

ORAL LIQUID ORDINARY LIQUIDS

1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

Page 1029: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0 ML BOTTLE

1.0X50.0 ML BOTTLE

1.0X30.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X200.0 ML BOTTLE

TOPICAL EXTERNAL POWDERS

1.0X30.0 G CONTAINER,1.0X50.0 G CONTAINER,1.0X75.0 G CONTAINER,1.0X100.0 G CONTAINER

ORAL LIQUID ORDINARY LIQUIDS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X1.0X6.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL LIQUIDS

TOPICAL EXTERNAL EMULSION GELS

1.0X1.0X20.0 G TUBE,1.0X1.0X10.0 G TUBE

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL OINTMENTS

1.0X30.0 G TUBE,1.0X10.0 G TUBE,1.0X100.0 G TUBE,1.0X250.0 G TUBE

Page 1030: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 G BOTTLE,1.0X10.0 G BOTTLE

1.0X30.0 G TUBE

1.0X200.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X500.0 G VIAL

1.0X60.0 TABLET BOTTLE

TOPICAL EXTERNAL POWDERS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X200.0 ML BOTTLE,1.0X30.0 ML BOTTLE

TOPICAL EXTERNAL GELS AND SOLS

TOPICAL EXTERNAL LIQUIDS

1.0X60.0 ML CONTAINER,1.0X30.0 ML CONTAINER,1.0X100.0 ML CONTAINER,1.0X500.0 ML CONTAINER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

1.0X100.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER,10.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER,1.0X500.0 CAPSULE CONTAINER

Page 1031: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.2 G VIAL

1.0X1.0X600.0 MG VIAL

1.0X10.0 ML VIAL

1.0X500.0 MG VIAL

1.0X100.0 MG VIAL

1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X10.0X10.0 CAPSULE BLISTER,1.0X1000.0 CAPSULE CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

1.0X1.0X6.0 ML AMPOULE,1.0X1.0X8.0 ML AMPOULE

PARENTERAL RETARD DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY OTHER COATED TABLETS

Page 1032: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 MG VIAL

1.0X1.0 G VIAL

1.0X30.0 ML VIAL

1.0X5.0X4.0 TABLET BLISTER

1.0X1.0X30.0 G TUBE

1.0X3.0X10.0 TABLET BLISTER

1.0X1.2 G VIAL

1.0X1.0 G VIAL

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL OTHER GELS/SOLS

TOPICAL EXTERNAL CREAMS

1.0X250.0 G TUBE,1.0X25.0 G TUBE,1.0X10.0 G TUBE

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 1033: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X7.0X1.0 ML AMPOULE

1.0X3.0X2.0 ML VIAL

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X500.0 MG VIAL

1.0X10.0 G CONTAINER

1.0X20.0 ML VIAL

1.0X10.0X7.5 ML VIAL

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X10.0 ML VIAL 1*10ML 0.9%NACL AMPOULE

TOPICAL EXTERNAL POWDERS

PARENTERAL ORDINARY DRY VIALS

1.0X30.0 MG VIAL + 1*5ML OF 0.9%W/V NACL AMPOULE + 1*1ML OF 5%W/V NAHCO3 AMPOULE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 1034: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1.0 G VIAL

1.0X10.0X2.0 ML AMPOULE

1.0X10.0X2.0 ML AMPOULE

1.0X4.5 G VIAL

1.0X500.0 MG VIAL

1.0X7.5 ML VIAL

1.0X10.0X2.0 ML AMPOULE

PARENTERAL ORDINARY I M VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X60.0 MG VIAL + 5 ML NACL + 1 ML SODIUM BICARBONATE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY I V AMPOULES

1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE

PARENTERAL ORDINARY DRY VIALS

1.0X30.0 MG VIAL + 1*5 ML OF 0.9%W/V NACL AMPOULE + 1*1 ML OF 5%W/V NAHCO3 AMPOULE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

Page 1035: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 ML VIAL

1.0X1.0 G VIAL

1.0X2.0 ML AMPOULE

1.0X1.0 G VIAL

1.0X5.0X3.0 ML AMPOULE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

1.0X120.0 MG VIAL + 1*2 ML AMPOULE OF SODIUM BICARBONATE + 1*10 ML VIAL OF 0.9%W/V SODIUM CHLORIDE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

1.0X1.0X60.0 MG VIAL + 1*1*5ML AMPOULE OF 0.9%W/V NACL + 1*1*1ML AMPOULE OF 5%W/V NAHCO3

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

1.0X2.0X10.0X4.0 ML AMPOULE,1.0X10.0X4.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

1.0X5.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

ORAL LIQUID ORDINARY SYRUPS

1.0X90.0 ML BOTTLE,1.0X250.0 ML BOTTLE

Page 1036: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X15.0 G TUBE

1.0X1.0X6.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X1.0X3.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X4.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X4.0 TABLET BLISTER

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 1037: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X30.0 G TUBE,1.0X4.0 G TUBE

1.0X150.0 ML CANNISTER

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY OTHER CAPSULES

TOPICAL EXTERNAL OTHER GELS/SOLS

1.0X50.0 G CONTAINER,1.0X15.0 G CONTAINER,1.0X30.0 G CONTAINER

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL PRESSURISED AEROSOLS

TOPICAL EXTERNAL CREAMS

1.0X15.0 G TUBE,1.0X35.0 G TUBE,1.0X67.0 G TUBE,1.0X100.0 G TUBE

TOPICAL EXTERNAL GELS AND SOLS

1.0X35.0 G TUBE,1.0X50.0 G TUBE,1.0X100.0 G TUBE

ORAL SOLID ORDINARY CAPSULES

Page 1038: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X500.0 MG VIAL

1.0X1.0 G VIAL

1.0X15.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X5.0X3.0X10.0 TABLET BLISTER

1.0X1.0X4.0 TABLET BLISTER

1.0X1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0X18.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY CHEWABLE TABLETS

10.0 TABLET CONTAINER,250.0 TABLET CONTAINER,500.0 TABLET CONTAINER,100.0 TABLET CONTAINER,1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY DROPS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY LIQUIDS

Page 1039: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 ML BOTTLE

1.0X15.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0X1.0X4.0 TABLET BLISTER

1.0X15.0 G TUBE

75.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X30.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X300.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL LIQUID SOAPS/WASHES

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

Page 1040: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X30.0 G TUBE

1.0X225.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X1.0X15.0 G TUBE

1.0X10.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X20.0 G TUBE

ORAL LIQUID ORDINARY SYRUPS

1.0X225.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY LIQUIDS

ORAL LIQUID ORDINARY SUSPENSIONS

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL SOLID ORDINARY TABLETS

2.0X50.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL CREAMS

Page 1041: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0 TABLET BLISTER

1.0X20.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 G TUBE

VAGINAL TABLETS 1.0X6.0 PESSARY STRIP

1.0X200.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X100.0 ML BOTTLE,1.0X60.0 ML BOTTLE

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,1.0X2.0X50.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL TOPICAL GELS AND SOLS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

Page 1042: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET STRIP

5.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET STRIP

10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X400.0 ML BOTTLE,1.0X160.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1043: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET STRIP

1.0X5.0X10.0 TABLET BLISTER

10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X1000.0 TABLET CONTAINER,2.0X5.0X10.0 TABLET BLISTER

ORAL SOLID RETARD TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X50.0X4.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

Page 1044: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X2.0X50.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X2.0X10.0 TABLET BLISTER

1.0X10.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY LIQUIDS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

Page 1045: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X100.0 MG VIAL

1.0X10.0X1.0 ML AMPOULE

1.0X50.0 ML VIAL,1.0X20.0 ML VIAL

1.0X30.0 ML BOTTLE

1.0X5.0X2.0 ML AMPOULE

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 ML VIAL

1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

1.0X5.0X3.0 ML AMPOULE,1.0X5.0X2.5 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY VIALS

TOPICAL EXTERNAL SPRAYS WITHOUT GAS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY ORALLY DISINTEGRATING TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 1046: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X2.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X100.0 ML BOTTLE

1.0X2.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 1047: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0X10.0 TABLET STRIP

1.0X100.0 ML BOTTLE

1.0X1.0 G VIAL

1.0X10.0 VIAL CARTON

1.0X10.0 ML VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY CAPSULES

Page 1048: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

VAGINAL TABLETS 1.0X6.0 PESSARY STRIP

1.0X100.0 MG VIAL

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X1.0 VIAL CARTON

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X500.0 MG VIAL

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY VIALS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 1049: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

1.0X10.0X10.0 CAPSULE BLISTER

1.0X2.0X7.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

10.0X10.0 CAPSULE BLISTER

1.0X500.0 MG BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X4.0X5.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

1.0X10.0X5.0X2.0 ML AMPOULE,1.0X5.0X5.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1050: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

1.0X4.0X5.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X10.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X7.0 TABLET STRIP,1.0X10.0X6.0 TABLET STRIP

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X2.0X10.0 TABLET BLISTER,5.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1051: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 TABLET STRIP

1.0X10.0X1.0X2.0 TABLET BLISTER

1.0X1.0X60.0 ML BOTTLE

1.0X5.0X2.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL LIQUID ORDINARY SUSPENSIONS

1.0X60.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

Page 1052: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X2.0 ML AMPOULE

1.0X20.0 G TUBE

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

ORAL LIQUID ORDINARY SUSPENSIONS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

1.0X50.0X4.0 TABLET STRIP,1.0X10.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

1.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER,14.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

10.0X10.0 TABLET BLISTER,14.0X10.0 TABLET BLISTER

PARENTERAL ORDINARY AMPOULES

ORAL TOPICAL GELS AND SOLS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

Page 1053: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X2.0X12.0 LOZENGE BLISTER

1.0X2.0X12.0 LOZENGE BLISTER

1.0X2.0X12.0 LOZENGE BLISTER

1.0X2.0X12.0 LOZENGE BLISTER

1.0X50.0 ML VIAL

1.0X50.0 ML VIAL,1.0X1.0X100.0 ML VIAL

1.0X10.0 G TUBE,1.0X100.0 G TUBE

TOPICAL EXTERNAL EMULSION GELS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY LOZENGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

1.0X5.0X10.0 TABLET BLISTER,1.0X10.0X10.0 TABLET BLISTER

Page 1054: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X100.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X2.0X8.0 LOZENGE BLISTER

1.0X2.0X8.0 LOZENGE BLISTER

1.0X2.0X8.0 LOZENGE BLISTER

1.0X2.0X12.0 LOZENGE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X50.0 G TUBE,1.0X20.0 G TUBE

ORAL LIQUID ORDINARY SUSPENSIONS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID ORDINARY LOZENGES

ORAL SOLID RETARD ENTERIC-COATED TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY FILM-COATED TABLETS

TOPICAL EXTERNAL GELS AND SOLS

PARENTERAL ORDINARY AMPOULES

1.0X100.0X3.0 ML AMPOULE,1.0X5.0X3.0 ML AMPOULE

Page 1055: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 G TUBE

1.0X100.0 ML BOTTLE

1.0X3.0X10.0 TABLET STRIP

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0 SUPPOSITORY BLISTER

1.0X1.0X15.0 TABLET BLISTER

1.0X1.0X15.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

TOPICAL EXTERNAL GELS AND SOLS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

RECTAL SYSTEMIC SUPPOSITORIES

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

Page 1056: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X50.0 TABLET CONTAINER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X7.0 TABLET BLISTER

1.0X50.0 TABLET BOTTLE

1.0X10.0 TABLET BLISTER

1.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

1.0X3.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CHEWABLE TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

Page 1057: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X125.0 ML BOTTLE

1.0X125.0 ML BOTTLE

1.0X1.0X10.0 G TUBE

1.0X60.0 ML BOTTLE,1.0X30.0 ML BOTTLE

1.0X10.0X10.0 TABLET BLISTER

1.0X60.0 TABLET BOTTLE

1.0X30.0 ML BOTTLE

1.0X1.0X4.0 TABLET BLISTER

ORAL LIQUID ORDINARY SYRUPS

1.0X200.0 ML BOTTLE,1.0X300.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

ORAL LIQUID ORDINARY SYRUPS

TOPICAL EXTERNAL CREAMS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL TOPICAL SUSPENSIONS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X500.0 TABLET CONTAINER,1.0X1000.0 TABLET CONTAINER

Page 1058: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

VAGINAL TABLETS 1.0X6.0 PESSARY STRIP

1.0X3.0X10.0 CAPSULE BLISTER

1.0X25.0 G TUBE

1.0X1.0X30.0 TABLET STRIP

1.0X1.0 VIAL CARTON

1.0X10.0X2.0 ML PRE- FILLED SYRINGE

1.0X5.0 ML VIAL

1.0X1.0X2.0 ML VIAL

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY I M AMPOULES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

Page 1059: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X1000.0 MG VIAL

1.0X20.0 ML VIAL

1.0X2.0 ML PRE- FILLED SYRINGE

1.0X1.0X30.0 ML VIAL

1.0X50.0 ML VIAL

1.0X2.0 ML VIAL

1.0X20.0 ML VIAL

1.0X20.0 ML VIAL

1.0X30.0 ML VIAL

1.0X500.0 MG VIAL

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY I V VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY I V VIALS

PARENTERAL ORDINARY DRY VIALS

Page 1060: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X45.0 VIAL CARTON

1.0X7.5 ML VIAL

1.0X20.0 ML VIAL

1.0X20.0 ML VIAL

1.0X1000.0 MG VIAL

1.0X5.0 ML VIAL

1.0X20.0 ML VIAL

1.0X1.0X1.0 ML VIAL

1.0X10.0 ML VIAL

1.0X50.0 MG VIAL

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY OTHER VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

Page 1061: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 MG VIAL

1.0X2.0 ML AMPOULE

1.0X500.0 MG VIAL

1.0X1.0 G VIAL

1.0X50.0 ML VIAL

1.0X1.0X50.0 MG VIAL

1.0X20.0 ML VIAL

1.0X50.0 ML VIAL

1.0X1.0 G VIAL

1.0X100.0 MG VIAL

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

Page 1062: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X5.0 ML VIAL

1.0X1.0X2.0 ML VIAL

1.0X3.0 ML VIAL

1.0X15.0 G TUBE

1.0X2.0 ML PRE- FILLED SYRINGE

1.0X15.0 G TUBE

1.0X15.0 G TUBE

1.0X0.85 ML PRE- FILLED SYRINGE

1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY VIALS

ORAL LIQUID ORDINARY LIQUIDS

TOPICAL EXTERNAL GELS AND SOLS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

TOPICAL EXTERNAL OINTMENTS

TOPICAL EXTERNAL GELS AND SOLS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY DRY VIALS

1.0X1.0 VIAL CARTON + 10 ML AMPOULE WFI

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

Page 1063: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X3.0X10.0 TABLET BLISTER

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

3.0 ML AMPOULE

3.0X10.0 CAPSULE BLISTER

10.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY CAPSULES

1.0X2.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

1.0X1.0 ML AMPOULE,1.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY TABLETS

ORAL SOLID RETARD TABLETS

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY SOLUBLE TABLETS

Page 1064: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0X10.0 CAPSULE BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X10.0X10.0 TABLET BLISTER

1.0X5.0X10.0 TABLET BLISTER

1.0X10.0X4.0 CAPSULE BLISTER

1.0X10.0X5.0 G SACHET

1.0X10.0X1.0 CAPSULE BLISTER

1.0X5.0X10.0 ML VIAL

1.0X100.0 ML BOTTLE

1.0X10.0 TABLET STRIP

ORAL SOLID ORDINARY CAPSULES

ORAL SOLID ORDINARY ENTERIC-COATED TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY UNIT DOSE POWDERS

ORAL SOLID ORDINARY CAPSULES

PARENTERAL ORDINARY I V VIALS

ORAL LIQUID ORDINARY SYRUPS

ORAL SOLID ORDINARY TABLETS

Page 1065: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X6.0 CAPSULE BLISTER

1.0X15.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X0.4 ML PRE- FILLED SYRINGE

1.0X0.5 ML PRE- FILLED SYRINGE

1.0X10.0 ML VIAL,1.0X3.0 ML VIAL

1.0X3.0 ML VIAL,1.0X10.0 ML VIAL

1.0X3.0 ML CARTRIDGE

1.0X10.0 G TUBE

1.0X3.0 ML VIAL,1.0X10.0 ML VIAL

ORAL SOLID ORDINARY CAPSULES

ORAL LIQUID ORDINARY DRY SUSPENSIONS/SYRUPS/DROPS

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY PRE-FILLED SYRINGES

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY S C VIALS

PARENTERAL ORDINARY CARTRIDGES

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY S C VIALS

Page 1066: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X0.5 ML VIAL

1.0X15.0 G TUBE

1.0X15.0 G TUBE

OPHTHALMIC DROPS 1.0X5.0 ML BOTTLE

1.0X20.0 TABLET BLISTER

2.0X15.0 G TUBE

1.0X5.0X5.0 TABLET STRIP

1.0X120.0 ML BOTTLE

1.0X15.0 G TUBE

1.0X45.0 G TUBE

PARENTERAL ORDINARY VIALS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY CHEWABLE TABLETS

TOPICAL EXTERNAL CREAMS

ORAL SOLID ORDINARY TABLETS

ORAL LIQUID ORDINARY LIQUIDS

TOPICAL EXTERNAL CREAMS

TOPICAL EXTERNAL CREAMS

Page 1067: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X10.0 TABLET BLISTER

1.0X10.0X10.0 BLISTER BLISTER

1.0X20.0 G TUBE

1.0X10.0 ML VIAL

1.0X1.0X30.0 CAPSULE BLISTER

1.0X100.0 ML BOTTLE

ORAL SOLID ORDINARY TABLETS

ORAL SOLID ORDINARY TABLETS

1.0X10.0X10.0 TABLET BLISTER,1.0X2.0X10.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

RECTAL SYSTEMIC SUPPOSITORIES

1.0X2.0X5.0 SUPPOSITORY STRIP,1.0X10.0X10.0 SUPPOSITORY STRIP

TOPICAL EXTERNAL CREAMS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY ENTERIC-COATED CAPSULES

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X100.0 ML BOTTLE,1.0X200.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

Page 1068: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X200.0 ML BOTTLE

1.0X200.0 ML BOTTLE

1.0X100.0 ML BOTTLE

1.0X10.0X5.0 CAPSULE BLISTER

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X200.0 ML BOTTLE,1.0X400.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X1.0X150.0 ML BOTTLE,1.0X1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X100.0 ML BOTTLE,1.0X20.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

TOPICAL EXTERNAL LIQUIDS

1.0X200.0 ML BOTTLE,1.0X100.0 ML BOTTLE,1.0X400.0 ML BOTTLE,1.0X1000.0 ML CONTAINER,1.0X2.0 ML CONTAINER

PARENTERAL ORDINARY INFUSION VIALS/BOTTLES

1.0X50.0 ML BOTTLE,1.0X100.0 ML BOTTLE

ORAL LIQUID ORDINARY SYRUPS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY COMBINATION PACK CAPSULES

Page 1069: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X30.0 ML BOTTLE

1.0X1.0 G VIAL

1.0X1.0X6.0 TABLET BLISTER

1.0X60.0 TABLET CONTAINER

1.0X10.0X10.0X2.0 ML AMPOULE

1.0X10.0X100.0 MG VIAL

1.0X10.0X10.0X3.0 ML AMPOULE

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY DRY VIALS

ORAL SOLID ORDINARY FILM-COATED TABLETS

ORAL SOLID ORDINARY FILM-COATED TABLETS

1.0X1.0X9.0 TABLET BLISTER,1.0X1.0X4.0 TABLET BLISTER,1.0X30.0X9.0 TABLET BLISTER

ORAL SOLID ORDINARY TABLETS

PARENTERAL ORDINARY AMPOULES

ORAL SOLID ORDINARY CAPSULES

1000.0 CAPSULE CONTAINER,1.0X100.0X10.0 CAPSULE BLISTER,1.0X10.0X10.0 CAPSULE BLISTER

PARENTERAL ORDINARY DRY VIALS

PARENTERAL ORDINARY AMPOULES

1.0X100.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

Page 1070: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X2.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

1.0X5.0X10.0X10.0 ML AMPOULE,1.0X10.0X10.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

1.0X100.0X1.0 ML AMPOULE,1.0X10.0X1.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

PARENTERAL ORDINARY AMPOULES

1.0X10.0X10.0X2.0 ML AMPOULE,1.0X10.0X2.0 ML AMPOULE

PARENTERAL ORDINARY AMPOULES

1.0X10.0X2.0 ML AMPOULE,1.0X10.0X10.0X2.0 ML AMPOULE

ORAL SOLID ORDINARY TABLETS

1.0X100.0X10.0 TABLET CONTAINER,1.0X10.0X10.0 TABLET BLISTER,1.0X1000.0 TABLET CONTAINER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

ORAL SOLID ORDINARY CAPSULES

1.0X1000.0 CAPSULE CONTAINER,1.0X10.0X10.0 CAPSULE BLISTER,1.0X100.0X10.0 CAPSULE BLISTER

Page 1071: … · XLS file · Web view · 2018-04-16150 mg pfizer gmbh arzeimitelwork -moswalda 1144 79090 freuburg nda/mal/hdp/3888 pyriren pyridoxine hydrochloride nda/mal/hdp/3889 lyrica

1.0X25.0X20.0 ML VIAL

1.0X10.0X10.0X3.0 ML AMPOULE

PARENTERAL ORDINARY VIALS

PARENTERAL ORDINARY AMPOULES