exhibit 27 - downloads.regulations.gov€¦ · drugs@fda: fda approved drug products page 2 of 2...

Exhibit 27

Drugs@FDA: FDA Approved Drug Products Page 1 of 2

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Drug Details

Drug Name(s)

FDA Application No.

Active Ingredient(s)

Company

Original Approval or Tentative Approval Date

• Therapeutic Equivalents

• Approval History, Letters, Reviews, and Related Documents

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

(ANDA) 203263

DOXORUBICIN HYDROCHLORIDE

SUN PHARMA GLOBAL

February 4, 2013

• Label Information

Products on Application (ANDA) #203263 Click on a column header to re-sort the table:

Drug Name Active Ingredients Strength Dosage Form/Route Marketing RLDTE Status Code



20MG/10ML (2MG/ML)

INJECTABLE, LIPOSOMAL;INJECTION

Prescription Yes AB

(LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE


50MG/25ML (2MG/ML)

INJECTABLE, LIPOSOMAL;INJECTION

Prescription Yes AB

(LIPOSOMAL)

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Exhibit 28

Prescription and Over-the-Counter Drug Product List 33rd Edition

Cumulative Supplement Number 6: June 2013

ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE; ORAL

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

>D> AA WRASER PHARMS LLC 356.4MG;30MG;16MG A040688 001 Apr 03, 2007 Jun DISC >A> 356.4MG;30MG;16MG

TABLET; ORAL

A040688 001 Apr 03, 2007 Jun DISC

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

>D> AA BOCA PHARMA 712.8MG;60MG;32MG A040701 001 Apr 03, 2007 Jun DISC >A> 712.8MG;60MG;32MG

ACETAMINOPHEN; CODEINE PHOSPHATE

A040701 001 Apr 03, 2007 Jun DISC

TABLET; ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

>D> AA MIKART 300MG;30MG A089238 001 Feb 25, 1986 Jun DISC >A> 300MG;30MG

ACETAMINOPHEN; HYDROCODONE BITARTRATE

A089238 001 Feb 25, 1986 Jun DISC

CAPSULE; ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

>D> AA MIKART 500MG;5MG A089008 001 Feb 21, 1986 Jun DISC >A> 500MG;5MG

TABLET; ORAL

A089008 001 Feb 21, 1986 Jun DISC

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

>A> AA CARACO 650MG;7.5MG A090380 001 Dec 23, 2008 Jun CAHN >A> AA 650MG;10MG A090380 002 Dec 23, 2008 Jun CAHN >A> AA 660MG;10MG A090380 003 Dec 23, 2008 Jun CAHN >A> AA 750MG;7.5MG A090380 004 Dec 23, 2008 Jun CAHN >D> AA SUN PHARM INDS INC 650MG;7.5MG A090380 001 Dec 23, 2008 Jun CAHN >D> AA 650MG;10MG A090380 002 Dec 23, 2008 Jun CAHN >D> AA 660MG;10MG A090380 003 Dec 23, 2008 Jun CAHN >D> AA 750MG;7.5MG

ACYCLOVIR

A090380 004 Dec 23, 2008 Jun CAHN

SUSPENSION; ORAL

ZOVIRAX

>A> AB + DELCOR ASSET 200MG/5ML N019909 001 Dec 22, 1989 Jun CAHN >D> AB + GLAXOSMITHKLINE 200MG/5ML

ALPRAZOLAM

N019909 001 Dec 22, 1989 Jun CAHN

TABLET, EXTENDED RELEASE; ORAL

ALPRAZOLAM

>D> AB TEVA PHARMS 0.5MG A077979 001 Feb 28, 2007 Jun DISC >0> AB 1MG A077979 002 Feb 28, 2007 Jun DISC >D> AB 2MG A077979 003 Feb 28, 2007 Jun DISC >D> AB 3MG A077979 004 Feb 28, 2007 Jun DISC >A> @ TEVA PHARMS USA 0.5MG A077979 001 Feb 28, 2007 Jun DISC >A> 1MG A077979 002 Feb 28, 2007 Jun DISC >A> 2MG A077979 003 Feb 28, 2007 Jun DISC >A> 3MG

AMIKACIN SULFATE

A077979 004 Feb 28, 2007 Jun DISC

INJECTABLE; INJECTION

AMIKACIN SULFATE

>D> @ TEVA PARENTERAL EQ 50MG BASE/ML A064045 001 Sep 28, 1993 Jun CAHN

PaRelofi9


>D>

>A> >A>

AP

AP


AMIKACIN SULFATE

TEVA PARENTERAL @ TEVA PHARMS USA

EQ 250MG BASE/ML EQ 50MG BASE/ML

EQ 250MG BASE/ML

A064045

A064045 A064045

002 001 002

Sep Sep Sep

28, 28,

28,

1993 1993

1993

Jun

Jun Jun

CAHN

CAHN CAHN

AMINOPHYLLINE


AMINOPHYLLINE

>D> AP INTL MEDICATION 251,4G/mL A087209 001 Feb 01, 1982 Jun DISC >A> 9 25mG/141, A087209 001 Feb 01, 1982 Jun DISC >D> AP PHARMA SERVE NY 25MG/ML A087392 001 Dec 15, 1983 Jun DISC >A>

>D>

9

AMLEXANOX

25MG/ML A087392 001 Dec 15, 1983 Jun DISC

>D> PASTE; DENTAL

>D> APHTHASOL

>D> + ULURU 5% NO20511 001 Dec 17, 1996 Jun DISC >A> 9

AMMONIA N-13

5% NO20511 001 Dec 17, 1996 Jun DISC

INJECTABLE; INTRAVENOUS

AMMONIA N 13

>A> AP UCLA BIOMEDICAL 30mci - 300mci/8mL (3.75 -

37.5MCl/ML) A203812 001 Jun 27, 2013 Jun NEWA

AMOXICILLIN

TABLET; ORAL

AMOXICILLIN

>D> AB DAVA PHARMS INC 875MG A065344 001 Jan 15, 2009 Jun DISC >A> 9

AMPICILLIN SODIUM

875MG A065344 001 Jan 15, 2009 Jun DISC


AMPICILLIN SODIUM

>D> AP ANTIBIOTICE EQ 250MG BAsE/vIAL A090354 001 Dec 28, 2009 Jun DISC >A> 9 EQ 250MG BAsE/vIAL A090354 001 Dec 28, 2009 Jun DISC >D> AP EQ 500MG BASE/VIAL A090354 002 Dec 28, 2009 Jun DISC >A> 9 EQ 500MG BASE/VIAL A090354 002 Dec 28, 2009 Jun DISC >D> AP EQ 1GM BASE/VIAL A090354 003 Dec 28, 2009 Jun DISC >A> 9 EQ 1GM BASE/VIAL A090354 003 Dec 28, 2009 Jun DISC >D> AP EQ 2GM BASE/VIAL A090354 004 Dec 28, 2009 Jun DISC >A> 9

AZELAIC ACID

EQ 2GM BASE/VIAL A090354 004 Dec 28, 2009 Jun DISC

GEL; TOPICAL

FINACEA

>A> + BAYER HLTHCARE 15% NO21470 001 Dec 24, 2002 Jun CAHN >D> + BHP DERMATOLOGY

BACITRACIN

15% NO21470 001 Dec 24, 2002 Jun CAHN

OINTMENT; OPHTHALMIC

BACITRACIN

>D> + FERA PHARMS 500 uNiTs/Gm A061212 001 Jun CAHN >A> + PERRIGO CO TENNESSEE 500 uNITs/Gm A061212 001 Jun CAHN

Paee 2 of 19


BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

>D> AT

>A> AT


NEOMYCIN AND POLYMYXIN

FERA PHARMS

PERRIGO CO TENNESSEE

B SULFATES AND BACITRACIN ZINC

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

A060764 002

A060764 002

Jun CAHN

Jun CAHN

BACITRACIN ZINC; POLYMYXIN B SULFATE


BACITRACIN ZINC AND POLYMYXIN B SULFATE

>D> AT

FERA PHARMS 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002 Jun CAHN >A> AT

PERRIGO CO TENNESSEE 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002 Jun CAHN

>D>

>A>

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Jun

Jun

CAHN

CAHN


BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

+ FERA PHARMS 400 UNITS/GM;1%;EQ 3.5MG A062166 002 BASE/GM;10,000 UNITS/GM

PERRIGO CO TENNESSEE 400 UNITS/GM;1%;EQ 3.5MG A062166 002 BASE/GM;10,000 UNITS/GM

BENZOYL PEROXIDE; ERYTHROMYCIN

GEL; TOPICAL

BENZAMYCIN PAK

>D> + VALEANT INTL 5%;3% N050769 001 Nov 27, 2000 Jun CAHN >A> + VALEANT LUXEMBOURG 5%;3%

BETHANECHOL CHLORIDE

N050769 001 Nov 27, 2000 Jun CAHN

TABLET; ORAL

BETHANECHOL CHLORIDE

>A> AA CARACO 5MG A040897 001 Apr 22, 2009 Jun CAHN >A> AA 10MG A040897 002 Apr 22, 2009 Jun CAHN >A> AA 25MG A040897 003 Apr 22, 2009 Jun CAHN >A> AA 50MG A040897 004 Apr 22, 2009 Jun CAHN >D> AA LANNETT 5MG A040703 001 Mar 27, 2008 Jun DISC >0> AA 50MG A040677 001 Mar 27, 2008 Jun DISC >A> @ LANNETT HOLDINGS INC 5MG A040703 001 Mar 27, 2008 Jun DISC >A> 50MG A040677 001 Mar 27, 2008 Jun DISC >D> AA SUN PHARM INDS INC 5MG A040897 001 Apr 22, 2009 Jun CAHN >D> AA 10MG A040897 002 Apr 22, 2009 Jun CAHN >D> AA 25MG A040897 003 Apr 22, 2009 Jun CAHN >D> AA 50MG

BEXAROTENE

A040897 004 Apr 22, 2009 Jun CAHN

CAPSULE; ORAL

TARGRETIN

>D> + EISAI INC 75MG NO21055 001 Dec 29, 1999 Jun CAHN >A> + VALEANT LUXEMBOURG 75MG

GEL; TOPICAL

NO21055 001 Dec 29, 1999 Jun CAHN

TARGRETIN

>A> + VALEANT LUXEMBOURG 1% NO21056 001 Jun 28, 2000 Jun CAHN

>D> + VALEANT PHARMS INC 1%

BUPIVACAINE HYDROCHLORIDE

NO21056 001 Jun 28, 2000 Jun CAHN


BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

>D> AP INTL MEDICATED 0.25% A076012 001 Jan 09, 2002 Jun DISC >A> 0.25% A076012 001 Jan 09, 2002 Jun DISC >D> AP 0.5% A076012 002 Jan 09, 2002 Jur

Page 3 of 19

ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT Lwr INJECTABLE; INJECTION

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

>A> @ INTL MEDICATED 0.5% A076012 002 Jan 09, 2002 Jun DISC >D> AP 0.75% A076012 003 Jan 09, 2002 Jun DISC >A> 9

BUTORPHANOL TARTRATE

0.75% A076012 003 Jan 09, 2002 Jun DISC


>D> STADOL

>D> AP + APOTHECON 2MG/ML N017857 004 Jun DISC >A> @ 2MG/ML N017857 004 Jun DISC >D> STADOL PRESERVATIVE FREE

>D> AP + APOTHECON 1MG/ML N017857 001 Jun DISC >A> @ 1MG/ML N017857 001 Jun DISC >D> AP + 2MG/ML N017857 002 Jun DISC >A> @ 2MG/ML N017857 002 Jun DISC

>A>

>D>

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

NO20577 001

NO20577 001

Sep

Sep

27,

27,

1996

1996

Jun

Jun

CAHN

CAHN

INJECTABLE; INTRATHECAL

ELLIOTTS B SOLUTION

+ LUKARE MEDICAL LLC

+ QOL MEDCL

0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3M G/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3M G/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML

CAPTOPRIL

TABLET; ORAL

CAPTOPRIL

>D> AB PRINSTON INC 12.5MG A074477 001 Feb 13, 1996 Jun DISC >A> @ 12.5MG A074477 001 Feb 13, 1996 Jun DISC >D> AB 25MG A074477 002 Feb 13, 1996 Jun DISC >A> @ 25MG A074477 002 Feb 13, 1996 Jun DISC >D> AB 50MG A074477 003 Feb 13, 1996 Jun DISC >A> @ 50MG A074477 003 Feb 13, 1996 Jun DISC >D> AB 100MG A074477 004 Feb 13, 1996 Jun DISC >A> @ 100MG A074477 004 Feb 13, 1996 Jun DISC >D> AB TEVA 12.5MG A074483 001 Feb 13, 1996 Jun DISC >A> @ 12.5MG A074483 001 Feb 13, 1996 Jun DISC >D> AB 25MG A074483 002 Feb 13, 1996 Jun DISC >A> @ 25MG A074483 002 Feb 13, 1996 Jun DISC >D> AB 50MG A074483 003 Feb 13, 1996 Jun DISC >A> @ 50MG A074483 003 Feb 13, 1996 Jun DISC >D> AB 100MG A074483 004 Feb 13, 1996 Jun DISC >A> @

CARBAMAZEPINE

100MG A074483 004 Feb 13, 1996 Jun DISC

CAPSULE, EXTENDED RELEASE; ORAL

CARBAMAZEPINE

>A> AB TARO 100MG A201106 001 Jun 21, 2013 Jun NEWA >A> AB 200MG A201106 002 Jun 21, 2013 Jun NEWA >A> AB

CARISOPRODOL

300MG A201106 003 Jun 21, 2013 Jun NEWA

TABLET; ORAL

CARISOPRODOL

>D> AA PROSAM LABS 350MG A040188 001 Mar 07, 1997 Jun DISC >A> 9 350MG A040188 001 Mar 07, 1997 Jur

Paae 4 of 19


CEFOTAXIME SODIUM


CEFOTAXIME SODIUM

>D> AP AUROBINDO PHARMA EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009 Jun DISC >A> 9 AUROBINDO PHARMA LTD

CEFTAZIDIME

EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009 Jun DISC


CEFTAZIDIME

>D> AP AUROBINDO PHARMA 500MG/VIAL A065481 001 May 28, 2010 Jun DISC >D> AP 1GM/VIAL A065481 002 May 28, 2010 Jun DISC >D> AP 2GM/VIAL A065481 003 May 28, 2010 Jun DISC >D> AP 6GM/VIAL A065482 001 May 28, 2010 Jun DISC >A> 9 AUROBINDO PHARMA LTD 500MG/VIAL A065481 001 May 28, 2010 Jun DISC >A> 9 1GM/VIAL A065481 002 May 28, 2010 Jun DISC >A> 8 2GM/VIAL A065481 003 May 28, 2010 Jun DISC >A> 8

CEFUROXIME SODIUM

6GM/VIAL A065482 001 May 28, 2010 Jun DISC


>D> ZINACEF IN PLASTIC CONTAINER

>D> + COVIS PHARMA EQ 15MG BASE/ML N050643 001 Apr 28, 1989 Jun DISC >A> 8 COVIS PHARMA SARL

CETIRIZINE HYDROCHLORIDE

EQ 15MG BASE/ML N050643 001 Apr 28, 1989 Jun DISC

SYRUP; ORAL

CETIRIZINE HYDROCHLORIDE

>A> AA CARACO 5MG/5ML A090191 001 Nov 12, 2009 Jun CAHN >D> AA SUN PHARM INDS INC

CETRORELIX

5MG/5ML A090191 001 Nov 12, 2009 Jun CAHN


CETROTIDE

>D> + EMD SERONO EQ 3mG BASE/ML NO21197 002 Aug 11, 2000 Jun DISC >A> 9 EMD SERONO INC

CEVIMELINE HYDROCHLORIDE

EQ 3MG BASE/ML NO21197 002 Aug 11, 2000 Jun DISC

CAPSULE; ORAL

CEVIMELINE HYDROCHLORIDE

>A> AB ROXANE

CHLOROTHIAZIDE SODIUM

30MG A091591 001 Jul 08, 2013 Jun NEWA


CHLOROTHIAZIDE SODIUM

>A> AP LUITPOLD EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013 Jun CAHN >D> AP PHARMAFORCE

CIMETIDINE

EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013 Jun CAHN

TABLET; ORAL

CIMETIDINE

>D> AB WATSON LABS 800MG A074316 001 Feb 28, 1996 Jun DISC >A> 9 WATSON LABS INC 800MG

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

A074316 001 Feb 28, 1996 Jun DISC


CIPROFLOXACIN EXTENDED RELEASE

>D> AB DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE A077701 002 Oct 31, 2007 Jun DISC >A> 9 212.6MG;EQ 287.5MG BASE A077701 002 Oct 31, 2007 Jun DISC

Pane 5 of 19


CITALOPRAM HYDROBROMIDE

TABLET; ORAL

CITALOPRAM HYDROBROMIDE

>D> AB NATCO PHARMA LTD EQ 20MG BASE A077141 002 Apr 10, 2008 Jun DISC >A> EQ 20MG BASE A077141 002 Apr 10, 2008 Jun DISC >D> AB EQ 40MG BASE A077141 001 Apr 10, 2008 Jun DISC >A> EQ 40MG BASE

CLOBETASOL PROPIONATE

A077141 001 Apr 10, 2008 Jun DISC

AEROSOL, FOAM; TOPICAL

OLUX E

>A> AB2 + DELCOR ASSET 0.05% NO22013 001 Jan 12, 2007 Jun CAHN >D> AB2 + STIEFEL LABS INC 0.05%

CREAM; TOPICAL

NO22013 001 Jan 12, 2007 Jun CAHN

CLOBETASOL PROPIONATE

>D> AB1 TEVA PHARMS 0.05% A074087 001 Feb 16, 1994 Jun DISC >A> @ TEVA PHARMS USA 0.05%

CYTARABINE

A074087 001 Feb 16, 1994 Jun DISC


CYTOSAR-U

>D> AP TEVA PARENTERAL 100MG/VIAL A075206 001 Dec 30, 1998 Jun CAHN >D> AP 500MG/VIAL A075206 002 Dec 30, 1998 Jun CAHN >D> AP 1GM/VIAL A075206 004 Dec 30, 1998 Jun CAHN >D> AP 2GM/VIAL A075206 003 Dec 30, 1998 Jun CAHN >A> AP TEVA PHARMS USA 100MG/VIAL A075206 001 Dec 30, 1998 Jun CAHN >A> AP 500MG/VIAL A075206 002 Dec 30, 1998 Jun CAHN >A> AP 1GM/VIAL A075206 004 Dec 30, 1998 Jun CAHN >A> AP 2GM/VIAL

DALTEPARIN SODIUM

A075206 003 Dec 30, 1998 Jun CAHN

INJECTABLE; SUBCUTANEOUS

FRAGMIN

>D> EISAI INC 10,000IU/0.4ML (25,000IU/ML) NO20287 002 May 01, 2007 Jun DISC >A> 10,000IU/0.4ML (25,000IU/ML) NO20287 002 May 01, 2007 Jun DISC >D> 95,000IU/9.5ML (10,000IU/ML) NO20287 007 Apr 04, 2002 Jun DISC >A> 95,000IU/9.5ML (10,000IU/ML)

DESONIDE

NO20287 007 Apr 04, 2002 Jun DISC

GEL; TOPICAL

DESONATE

>A> + BAYER HLTHCARE 0.05% NO21844 001 Oct 20, 2006 Jun CAHN >D> + BHP DERMATOLOGY 0.05%

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

NO21844 001 Oct 20, 2006 Jun CAHN


NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

>0> AT FERA PHARMS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

A062938 001 Jul 31, 1989 Jun CAHN

>A> AT PERRIGO CO TENNESSEE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

A062938 001 Jul 31, 1989 Jun CAHN

DIAZEPAM


DIAZEPAM

>D> AP WATSON LABS 5MG/ML A070296 001 Feb 12, 1986 Jun DISC

>A> 5MG/ML A070296 001 Feb 12, 1986 Jun DISC

Paae 6 of 19


>D>

>A>

DIFLORASONE DIACETATE

0.05%

0.05%

NO20205

NO20205

001

001

Nov 20,

Nov 20,

1992

1992

Jun

Jun

CAHN

CAHN

CREAM; TOPICAL

PSORCON

@ TARO @ TARO PHARMS NORTH

DIGOXIN

TABLET; ORAL

DIGOXIN

>D> AB CARACO 0.125MG A076363 001 Jan 31, 2003 Jun DISC >A> @ 0.125MG A076363 001 Jan 31, 2003 Jun DISC >D> AB 0.25MG A076363 002 Jan 31, 2003 Jun DISC >A> @

DIPYRIDAMOLE

0.25MG A076363 002 Jan 31, 2003 Jun DISC

TABLET; ORAL

DIPYRIDAMOLE

>D> AB PROSAM LABS 25MG A040542 001 Apr 21, 2006 Jun DISC >A> @ 25MG A040542 001 Apr 21, 2006 Jun DISC >D> AB 50MG A040542 002 Apr 21, 2006 Jun DISC >A> @ 50MG A040542 002 Apr 21, 2006 Jun DISC >D> AB 75MG A040542 003 Apr 21, 2006 Jun DISC >A> @

DONEPEZIL HYDROCHLORIDE

75MG A040542 003 Apr 21, 2006 Jun DISC

TABLET; ORAL

DONEPEZIL HYDROCHLORIDE

>A> AB ALVOGEN PINE BROOK 5MG A202114 001 Jul 05, 2013 Jun NEWA >A> AB

DOXEPIN HYDROCHLORIDE

10MG A202114 002 Jul 05, 2013 Jun NEWA

CAPSULE; ORAL

DOXEPIN HYDROCHLORIDE

>D> AB + MYLAN PHARMS INC EQ 10MG BASE A070791 002 May 13, 1986 Jun CRLD >A> AB EQ 10MG BASE A070791 002 May 13, 1986 Jun CRLD >D> AB EQ 25MG BASE A070791 003 May 13, 1986 Jun CRLD >A> AB +


EQ 25MG BASE A070791 003 May 13, 1986 Jun CRLD



>D> AP TEVA PARENTERAL 2MG/ML A064140 001 Jul 28, 1995 Jun CAHN >D> AP 200MG/100ML A064140 002 Jul 28, 1995 Jun CAHN >A> AP TEVA PHARMS USA 2MG/ML A064140 001 Jul 28, 1995 Jun CAHN >A> AP 200MG/100ML A064140 002 Jul 28, 1995 Jun CAHN

INJECTABLE, LIPOSOMAL; INJECTION

DOXIL (LIPOSOMAL)

>D> AB + JANSSEN RES AND DEV 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995 Jun CRLD >A> AB 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995 Jun CRLD >0> AB + 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000 Jun CRLD >A> AB 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000 Jun CRLD

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

>D> AB SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013 Jun CRLD >A> AB + 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013 Jun CRLD >D> AB 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013 Jun CRLD >A> AB + 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013 Jun CRLD

Paae 7 of 19


ERTAPENEM SODIUM

IV (INFUSION) INJECTABLE; INTRAMUSCULAR,

INVANZ >D> + MERCK EQ 1GM BASE/VIAL 14021337 001 Nov 21, 2001 Jun CAHN >A> + MERCK SHARP DOHME

ERYTHROMYCIN

EQ 1GM BASE/VIAL 14021337 001 Nov 21, 2001 Jun CAHN

OINTMENT; OPHTHALMIC ERYTHROMYCIN

>D> AT + FERA PHARMS 0.5% A062447 001 Sep 26, 1983 Jun CAHN >A> AT + PERRIGO CO TENNESSEE

ESTRADIOL VALERATE

0.5% A062447 001 Sep 26, 1983 Jun CAHN


ESTRADIOL VALERATE >D> AO WATSON LABS 20MG/ML A083547 001 Jun DISC >D> AO 40MG/ML A083714 001 Jun DISC >A> 0 40MG/ML A083714 001 Jun DISC >A> 8 WATSON LABS INC 20MG/ML A083547 001 Jun DISC

>D> ESTRONE

>D> INJECTABLE; INJECTION >D> ESTRONE >D> + WATSON LABS 5MG/ML A085239 001 Jun DISC >A> @ 5MG/ML A085239 001 Jun DISC

FINASTERIDE

TABLET; ORAL FINASTERIDE

>A> AB HETERO LABS LTD III 1MG A090060 001 Jul 01, 2013 Jun NEWA >A> AB SUN PHARMA GLOBAL

FLUDEOXYGLUCOSE F-18

1MG A090508 001 Jul 01, 2013 Jun NEWA

INJECTABLE; INTRAVENOUS FLUDEOXYGLUCOSE F18

>D> HOUSTON CYCLOTRON 20-500mCi/ML A203665 001 Feb 14, 2013 Jun CRLD >A> + 20-500mCi/ML A203665 001 Feb 14, 2013 Jun CRLD >A> + UCLA BIOMEDICAL

FLUVOXAMINE MALEATE

4-40mCi/ML A203811 001 Jun 27, 2013 Jun NEWA

TABLET; ORAL FLUVOXAMINE MALEATE

>D> AB CARACO 25MG A075900 001 Feb 23, 2006 Jun DISC >A> @ 25MG A075900 001 Feb 23, 2006 Jun DISC >D> AB 50MG A075900 002 Feb 23, 2006 Jun DISC >A> 0 50MG A075900 002 Feb 23, 2006 Jun DISC >D> AB 100MG A075900 003 Feb 23, 2006 Jun DISC >A> 8

GABAPENTIN

100MG A075900 003 Feb 23, 2006 Jun DISC

SOLUTION; ORAL

GABAPENTIN >A> AA TARO

GEMFIBROZIL

250MG/5ML A076672 001 Jul 03, 2013 Jun NEWA

TABLET; ORAL GEMFIBROZIL

>A> AB CARACO 600MG A079239 001 Dec 29, 2008 Jun CAHN

Paee 8 of 19

ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL

GEMFIBROZIL

>0> AB SUN PHARM INDS INC

GENTAMICIN SULFATE

600MG A079239 001 Dec 29, 2008 Jun CAHN


GENTAMICIN SULFATE

>D> AT FERA PHARMS EQ 0.3% BASE A065024 001 Jul 30, 2004 Jun CAHN >A> AT PERRIGO CO TENNESSEE

SOLUTION/DROPS; OPHTHALMIC

EQ 0.3% BASE A065024 001 Jul 30, 2004 Jun CAHN

GENTAMICIN SULFATE

>D> AT FERA PHARMS EQ 0.3% BASE A065121 001 Jan 30, 2004 Jun CAHN >A> AT PERRIGO CO TENNESSEE

GUANFACINE HYDROCHLORIDE

EQ 0.3% BASE A065121 001 Jan 30, 2004 Jun CAHN

TABLET; ORAL

GUANFACINE HYDROCHLORIDE

>D> AB EPIC PHARMA EQ 1MG BASE A074673 001 Feb 28, 1997 Jun DISC >D> AB EQ 2MG BASE A074673 002 Feb 28, 1997 Jun DISC >A> @ EPIC PHARMA LLC EQ 1MG BASE A074673 001 Feb 28, 1997 Jun DISC >A>

HALOBETASOL PROPIONATE

EQ 2MG BASE A074673 002 Feb 28, 1997 Jun DISC

OINTMENT; TOPICAL

HALOBETASOL PROPIONATE

>A> @ G AND W LABS INC 0.05% A077109 001 Jun 14, 2005 Jun CAHN >D> @ VENUS PHARMS

HALOPERIDOL DECANOATE

0.05% A077109 001 Jun 14, 2005 Jun CAHN


HALOPERIDOL DECANOATE

>D> AO TEVA PARENTERAL EQ 50MG BASE/ML A075393 001 May 11, 1999 Jun CAHN >D> AO EQ 100MG BASE/ML A075393 002 May 11, 1999 Jun CAHN >A> AO TEVA PHARMS USA EQ 50MG BASE/ML A075393 001 May 11, 1999 Jun CAHN >A> AO

HALOPERIDOL LACTATE

EQ 100MG BASE/ML A075393 002 May 11, 1999 Jun CAHN


HALOPERIDOL

>D> AP TEVA PARENTERAL EQ 5MG BASE/ML A076035 001 Aug 29, 2001 Jun CAHN

>A> AP TEVA PHARMS USA

HYDRALAZINE HYDROCHLORIDE

EQ 5MG BAsE/NIL A076035 001 Aug 29, 2001 Jun CAHN

TABLET; ORAL

HYDRALAZINE HYDROCHLORIDE

>D> AA ZYDUS PHARMS USA 10MG A040858 001 Feb 26, 2010 Jun DISC

>A> 10MG A040858 001 Feb 26, 2010 Jun DISC

>D> AA 25MG A040858 002 Feb 26, 2010 Jun DISC >A> 25MG A040858 002 Feb 26, 2010 Jun DISC

>D> AA 50MG A040858 003 Feb 26, 2010 Jun DISC

>A> 50MG A040858 003 Feb 26, 2010 Jun DISC

>D> AA 100MG A040858 004 Feb 26, 2010 Jun DISC

>A>

HYDROXYUREA

100MG A040858 004 Feb 26, 2010 Jun DISC

CAPSULE; ORAL

HYDROXYUREA

>A> @ BARR LABS INC 250MG A075020 002 Jun 26, 2000 Jun CAHN

>A> 500MG A075020 001 Jul 30, 1998 Jun CAHN

>D> @ DURAMED PHARMS BARR 250MG A075020 002 Jun 26, 2000 Jun CAHN

Paee 9 of 19

ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST CAPSULE; ORAL

HYDROXYUREA

>D> @ DURAMED PHARMS BARR

HYDROXYZINE HYDROCHLORIDE

500MG A075020 001 Jul 30, 1998 Jun CAHN

TABLET; ORAL

HYDROXYZINE HYDROCHLORIDE

>A> AB CARACO 10MG A040899 001 Jun 10, 2008 Jun CAHN >A> AB 25MG A040899 002 Jun 10, 2008 Jun CAHN >A> AB 50MG A040899 003 Jun 10, 2008 Jun CAHN >D> AB SUN PHARM INDS INC 10MG A040899 001 Jun 10, 2008 Jun CAHN >D> AB 25MG A040899 002 Jun 10, 2008 Jun CAHN >D>

>A>

AB

ICOSAPENT ETHYL

50MG A040899 003 Jun 10, 2008 Jun CAHN

>A> CAPSULE; ORAL

>A> VASCEPA

>A> + AMARIN PHARMS

IMIPRAMINE PAMOATE

1GM N202057 001 Jul 26, 2012 Jun NEWA

CAPSULE; ORAL

IMIPRAMINE PAMOATE

>A> AB MYLAN PHARMS INC EQ 75MG HCL A202338 001 Jun 28, 2013 Jun NEWA >A> AB EQ 100MG HCL A202338 002 Jun 28, 2013 Jun NEWA >A> AB EQ 125MG HCL A202338 003 Jun 28, 2013 Jun NEWA >A> AB

INDINAVIR SULFATE

EQ 150MG HCL A202338 004 Jun 28, 2013 Jun NEWA

CAPSULE; ORAL

CRIXIVAN

>D> MERCK SHARP DOHME EQ 100MG BASE NO20685 006 Apr 19, 2000 Jun DISC >A> 8

INDOMETHACIN

EQ 100MG BASE NO20685 006 Apr 19, 2000 Jun DISC

CAPSULE; ORAL

INDOMETHACIN

>A> AB CARACO 25MG A091401 001 Mar 28, 2013 Jun CAHN >A> AB 50MG A091401 002 Mar 28, 2013 Jun CAHN >D> AB SUN PHARM INDS INC 25MG A091401 001 Mar 28, 2013 Jun CAHN >D> AB

ISONIAZID

50MG A091401 002 Mar 28, 2013 Jun CAHN

TABLET; ORAL

ISONIAZID

>D> AA WATSON LABS 300MG A080521 001 Jun DISC >A> 300MG A080521 001 Jun DISC

ISOSORBIDE DINITRATE

TABLET; SUBLINGUAL

ISOSORBIDE DINITRATE

>D> AB WATSON LABS 2.5MG A086033 001 Feb 26, 1988 Jun DISC >A> 8 2.5MG A086033 001 Feb 26, 1988 Jun DISC >D> AB + 5MG A086031 001 Sep 29, 1987 Jun DISC >A> 0 5MG A086031 001 Sep 29, 1987 Jun DISC >D> AB WEST WARD 5MG A086055 001 Nov 02, 1987 Jun CRLD >A> AB + WEST WARD PHARM CORP 5MG A086055 001 Nov 02, 1987 Jun CRLD

Pa2e 10 of 19


>D> >A>

>D> >A>

ISRADIPINE

NO20336

NO20336

NO20336 NO20336

001

001

002 002

Jun

Jun

Jun Jun

01,

01,

01, 01,

1994

1994

1994 1994

Jun

Jun

Jun Jun

DISC

DISC DISC

DISC


DYNACIRC CR

GLAXOSMITHKLINE LLC 5MG

@ 5MG

+ 10MG

@ 10MG

KETOROLAC TROMETHAMINE


KETOROLAC TROMETHAMINE

>D> AP LUITPOLD 15MG/ML A078145 001 Jan 14, 2008 Jun DISC >A> 8 15MG/ML A078145 001 Jan 14, 2008 Jun DISC >D> AP 30MG/ML A078145 002 Jan 14, 2008 Jun DISC >A> @ 30MG/ML

LAMOTRIGINE

A078145 002 Jan 14, 2008 Jun DISC

TABLET; ORAL

LAMOTRIGINE

>A> AB ALKEM LABS LTD 25MG A200694 001 Jun 14, 2013 Jun NEWA >A> AB 100MG A200694 002 Jun 14, 2013 Jun NEWA >A> AB 150MG A200694 003 Jun 14, 2013 Jun NEWA >A> AB 200MG


A200694 004 Jun 14, 2013 Jun NEWA

LAMOTRIGINE

>A> AB DR REDDYS LABS LTD 25MG A202383 001 Jun 19, 2013 Jun NEWA >A> AB 50MG A202383 002 Jun 19, 2013 Jun NEWA >A> AB 100MG A202383 003 Jun 19, 2013 Jun NEWA >A> AB 200MG A202383 004 Jun 19, 2013 Jun NEWA >A> AB 300MG A202383 005 Jun 19, 2013 Jun NEWA >A> AB WILSHIRE PHARMS INC 25MG A202887 001 Jun 17, 2013 Jun NEWA >A> AB 50MG A202887 002 Jun 17, 2013 Jun NEWA >A> AB 100MG A202887 003 Jun 17, 2013 Jun NEWA

>A> AB 200MG

LENALIDOMIDE

A202887 004 Jun 17, 2013 Jun NEWA

CAPSULE; ORAL

REVLIMID

>A>

>D>

CELGENE 20MG

LEPIRUDIN RECOMBINANT

NO21880 006 Jun 5, 2013 Jun NEWA

>D> INJECTABLE; INJECTION

>D> REFLUDAN

>D> + BAYER HLTHCARE 50MG/VIAL NO20807 001 Mar 6, 1998 Jun DISC >A> @ 50MG/VIAL

LEUCOVORIN CALCIUM

NO20807 001 Mar 06, 1998 Jun DISC


LEUCOVORIN CALCIUM PRESERVATIVE FREE

>0> AP LUITPOLD EQ 50MG BASE/VIAL A040338 001 Jan 31, 2001 Jun DISC >A> 9 EQ SONG BASE/VIAL

LEVETIRACETAM

• A040338 001 Jan 31, 2001 Jun DISC

INJECTABLE; IV (INFUSION)

LEVETIRACETAM

>A> AP SAGENT PHARMS 500MG/5ML (100MG/ML) A091627 001 Jun 26, 2013 Jun NEWA

Page 11 of 19


>A>

>A>

>A>

AP

AP

AP

LEVOFLOXACIN

A200674 A200674

A200674

001

002

003

Jun

Jun

Jun

19,

19,

19,

2013

2013

2013

Jun

Jun

Jun

NEWA

NEWA NEWA


LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

FRESENIUS KABI USA EQ 250MG/50ML (EQ 5MG/ML)

EQ 500MG/100ML (EQ 5MG/ML)

EQ 750MG/150ML (EQ 5MG/ML)

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE


>D> ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

>D> AP NOVOCOL 0.05MG/ML;2% A084697 001 Jun DISC

>A> @ 0.05MG/ML;2% A084697 001 Jun DISC

SCANDONEST L

>0> AP DEPROCO 0.05MG/ML;2% A088388 001 Oct 10, 1984 Jun CRLD

>A> + 0.05MG/ML;2%

LIDOCAINE HYDROCHLORIDE

A088388 001 Oct 10, 1984 Jun CRLD

JELLY; TOPICAL

LIDOCAINE HYDROCHLORIDE

>D> AT TEVA PHARMS 2% A081318 001 Apr 29, 1993 Jun DISC

>A> @ TEVA PHARMS USA 2%

MEFLOQUINE HYDROCHLORIDE

A081318 001 Apr 29, 1993 Jun DISC

TABLET; ORAL

MEFLOQUINE HYDROCHLORIDE

>0> AB WEST WARD 250MG A077699 001 Apr 21, 2010 Jun DISC

>A> @ WEST WARD PHARM CORP 250MG

METAXALONE

A077699 001 Apr 21, 2010 Jun DISC

TABLET; ORAL

METAXALONE

>A> AB AMNEAL PHARMS 800MG

METFORMIN HYDROCHLORIDE

A203399 001 Jun 21, 2013 Jun NEWA


METFORMIN HYDROCHLORIDE

>D> AB TORRENT PHARMS 750MG A079226 001 Feb 18, 2010 Jun DISC

>A>

>D>

@ TORRENT PHARMS LTD 750MG

METHYL AMINOLEVULINATE HYDROCHLORIDE

A079226 001 Feb 18, 2010 Jun DISC

>D> CREAM; TOPICAL

>D> METVIXIA

>D> + GALDERMA LABS LP EQ 16.8% BASE NO21415 001 Jul 27, 2004 Jun DISC

>A> @ EQ 16.8% BASE

METHYLPHENIDATE HYDROCHLORIDE

NO21415 001 Jul 27, 2004 Jun DISC


CONCERTA

>D> JANSSEN PHARMS 18MG NO21121 001 Aug 01, 2000 Jun CTEC

>A> AB 18MG

METHYLPHENIDATE HYDROCHLORIDE

NO21121 001 Aug 01, 2000 Jun CTEC

>A> AB KUDCO IRELAND 18MG A091695 001 Jul 09, 2013 Jun NEWA

>A> AB 27MG

METOLAZONE

A091695 002 Jul 09, 2013 Jun NEWA

TABLET; ORAL

METOLAZONE

>D> AB TEVA 5MG A076833 001 Mar 01, 2004 Jun DISC

Page 12 of 19


>A>

TABLET; ORAL

METOLAZONE

@ TEVA

METYROSINE

5MG A076833 001 Mar 01, 2004 Jun DISC

CAPSULE; ORAL

DEMSER

>A> + ATON PHARMA VPNA 250MG N017871 001 Jun CAHN

>D> + BIOVAIL TECHNOLOGIES 250MG N017871 001 Jun CAHN

MIDAZOLAM HYDROCHLORIDE


MIDAZOLAM HYDROCHLORIDE

>D> AP INTL MEDICATED EQ 1MG BASE/ML A076144 001 Jan 26, 2005 Jun DISC >A> @ EQ 1MG BASE/ML A076144 001 Jan 26, 2005 Jun DISC >0> AP EQ 5MG BASE/ML A076144 002 Jan 26, 2005 Jun DISC >A> @

MIRTAZAPINE

EQ 5MG BASE/ML A076144 002 Jan 26, 2005 Jun DISC

TABLET, ORALLY DISINTEGRATING; ORAL

MIRTAZAPINE

>D> AB ACTAVIS ELIZABETH 15MG A077959 001 Feb 14, 2011 Jun DISC >A> @ 15MG A077959 001 Feb 14, 2011 Jun DISC >0> AB 30MG A077959 002 Feb 14, 2011 Jun DISC >A> @ 30MG A077959 002 Feb 14, 2011 Jun DISC >D> AB 45MG A077959 003 Feb 14, 2011 Jun DISC >A> @

MYCOPHENOLATE MOFETIL

45MG A077959 003 Feb 14, 2011 Jun DISC

CAPSULE; ORAL

MYCOPHENOLATE MOFETIL

>A> AB ALKEM LABS LTD

NAFTIFINE HYDROCHLORIDE

250MG A200197 001 Jun 13, 2013 Jun NEWA

GEL; TOPICAL

NAFTIN

>A> + MERZ PHARMS

NELFINAVIR MESYLATE

2% N204286 001 Jun 27, 2013 Jun NEWA

>D> POWDER; ORAL

>0> VIRACEPT

>D> + AGOURON EQ 50MG BASE/SCOOPFUL NO20778 001 Mar 14, 1997 Jun DISC

>A> @

NORETHINDRONE

EQ 50MG BASE/SCOOPFUL NO20778 001 Mar 14, 1997 Jun DISC

TABLET; ORAL-28

NORETHINDRONE

>A> AB1 FAMY CARE LTD

OXYBUTYNIN

0.35MG A201483 001 Jun 24, 2013 Jun NEWA

GEL, METERED; TRANSDERMAL

>D> ANTUROL

>0>

>A>

+ WATSON LABS INC

GELNIQUE 3%

3% N202513 001 Dec 07, 2011 Jun CTNA

>A> + WATSON LABS INC 3% N202513 001 Dec 07, 2011 Jun CTNA

Page 13 of 19


OXYBUTYNIN CHLORIDE

SYRUP; ORAL

OXYBUTYNIN CHLORIDE

>D> AA MIKART 5MG/5ML A075039 001 Jan 29, 1999 Jun DISC >A> @

OXYCODONE HYDROCHLORIDE

5MG/5ML A075039 001 Jan 29, 1999 Jun DISC

TABLET; ORAL

OXYCODONE HYDROCHLORIDE

>D> @ NESHER PHARMS 5MG A077290 001 Dec 08, 2005 Jun CMFD >A> AB 5MG A077290 001 Dec 08, 2005 Jun CMFD >0> @ 10MG A077290 002 Dec 08, 2005 Jun CMFD >A> AB 10MG A077290 002 Dec 08, 2005 Jun CMFD >D> @ 15MG A077290 003 Dec 08, 2005 Jun CMFD >A> AB 15MG A077290 003 Dec 08, 2005 Jun CMFD >D> @ 20MG A077290 004 Dec 08, 2005 Jun CMFD >A> AB 20MG A077290 004 Dec 08, 2005 Jun CMFD >0> @ 30MG A077290 005 Dec 08, 2005 Jun CMFD >A> AB

PAROXETINE MESYLATE

30MG A077290 005 Dec 08, 2005 Jun CMFD

>A> CAPSULE; ORAL

>A> BRISDELLE

>A> + NOVEN THERAP

PHYTONADIONE

EQ 7.5MG BASE N204516 001 Jun 28, 2013 Jun NEWA

TABLET; ORAL

MEPHYTON

>0> + VALEANT PHARMS 5MG N010104 003 Jun CAHN >A> + 5MG N010104 003 Jun CAHN

PINDOLOL

TABLET; ORAL

PINDOLOL

>D> AB MYLAN 5MG A074019 001 Sep 03, 1992 Jun CTEC >D> AB + 10MG A074019 002 Sep 03, 1992 Jun CTEC >A> MYLAN PHARMS INC 5MG A074019 001 Sep 03, 1992 Jun CTEC >A> + 10MG A074019 002 Sep 03, 1992 Jun CTEC >D> AB WATSON LABS 5MG A074437 001 Feb 27, 1995 Jun DISC >A> @ 5MG A074437 001 Feb 27, 1995 Jun DISC >ID> AB 10MG A074437 002 Feb 27, 1995 Jun DISC >A> @

PRAMLINTIDE ACETATE

10MG A074437 002 Feb 27, 1995 Jun DISC

INJECTABLE; SUBCUTANEOUS

SYMLIN

>D> AMYLIN PHARMS EQ 2.7MG BASE/2.7ML BASE/ML)

(EQ 1MG NO21332 003 Sep 25, 2007 Jun CRLD

>D> EQ 3MG BASE/5ML (EQ BASE/ML)

600MCG NO21332 001 Mar 16, 2005 Jun DISC

>A> + AMYLIN PHARMS LLC EQ 2.7MG BASE/2.7ML BASE/ML)

(EQ 1MG NO21332 003 Sep 25, 2007 Jun CRLD

>A> @ EQ 3MG BASE/5ML (EQ BASEPIL)

600MCG NO21332 001 Mar 16, 2005 Jun DISC

PRAZIQUANTEL

TABLET; ORAL

BILTRICIDE

>A> + BAYER HLTHCARE 600MG N018714 001 Dec 29, 1982 Jun CAHN >D> + BAYER PHARMA AG 600MG N018714 001 Dec 29, 1982 Jun CAHN

Pane 14 of 19


>D>

>D>

>A> >A>

QUAZEPAM

7.5MG

15MG 7.5MG 15MG

N018708

N018708

N018708 N018708

003

001

003 001

Feb

Dec

Feb Dec

26,

27,

26, 27,

1987

1985

1987 1985

Jun

Jun

Jun Jun

CAHN

CAHN CAHN

CAHN

TABLET; ORAL

DORAL

@ QUESTCOR PHARMS

+ @ SCIECURE PHARMA INC

+

RANITIDINE HYDROCHLORIDE

GRANULE, EFFERVESCENT; ORAL

ZANTAC 150

>A> @ GLAXO GRP LTD EQ 150MG BASE/PACKET NO20251 002 Mar 31, 1994 Jun CAHN >D> 8 GLAXOSMITHKLINE


EQ 150MG BASE/PACKET NO20251 002 Mar 31, 1994 Jun CAHN

>D> ZANTAC IN PLASTIC CONTAINER

>D> + COVIS PHARMA EQ 1MG BASE/ML N019593 002 Sep 27, 1991 Jun DISC >A> 8 COVIS PHARMA SARL

SYRUP; ORAL

EQ 1MG BASE/ML N019593 002 Sep 27, 1991 Jun DISC

ZANTAC

>A> AA + GLAXO GRP LTD EQ 15MG BASE/ML N019675 001 Dec 30, 1988 Jun CAHN >D> AA + GLAXOSMITHKLINE

TABLET; ORAL

EQ 15MG BASE/ML N019675 001 Dec 30, 1988 Jun CAHN

ZANTAC 150

>A> AB GLAXO GRP LTD EQ 150MG BASE N018703 001 Jun 09, 1983 Jun CAHN >D> AB GLAXOSMITHKLINE

ZANTAC 300

EQ 150MG BASE N018703 001 Jun 09, 1983 Jun CAHN

>A> AB + GLAXO GRP LTD EQ 300MG BASE N018703 002 Dec 09, 1985 Jun CAHN >D> AB + GLAXOSMITHKLINE EQ 300MG BASE N018703 002 Dec 09, 1985 Jun CAHN

TABLET, EFFERVESCENT; ORAL

ZANTAC 150

>A> 8 GLAXO GRP LTD EQ 150MG BASE NO20251 001 Mar 31, 1994 Jun CAHN >D> @ GLAXOSMITHKLINE

ZANTAC 25

EQ 150MG BASE NO20251 001 Mar 31, 1994 Jun CAHN

>A> + GLAXO GRP LTD EQ 25MG BASE NO20251 003 Apr 01, 2004 Jun CAHN >D> + GLAXOSMITHKLINE

RASAGILINE MESYLATE

EQ 25MG BASE NO20251 003 Apr 01, 2004 Jun CAHN

TABLET; ORAL

AZILECT

>D> TEVA EQ 0.5MG BASE NO21641 001 May 16, 2006 Jun CFTG >A> AB EQ 0.5MG BASE NO21641 001 May 16, 2006 Jun CFTG

>0> + EQ 1MG BASE NO21641 002 May 16, 2006 Jun CFTG >A>

>A>

AB +

RASAGILINE MESYLATE

EQ 1MG BASE NO21641 002 May 16, 2006 Jun CFTG

>A> AB WATSON LABS INC EQ 0.5MG BASE A201823 001 Jul 01, 2013 Jun NEWA >A> AB

RILUZOLE

EQ 1MG BASE A201823 002 Jul 01, 2013 Jun NEWA

TABLET; ORAL

RILUZOLE

>A> AB APOTEX CORP 50MG A091300 001 Jun 18, 2013 Jun NEWA >A> AB GLENMARK GENERICS 50MG A091394 001 Jun 18, 2013 Jun NEWA

>A> AB MYLAN PHARMS INC 50MG A203042 001 Jul 01, 2013 Jun NEWA >A> AB SUN PHARM INDS LTD

RIZATRIPTAN BENZOATE

50MG A091417 001 Jun 18, 2013 Jun NEWA

TABLET; ORAL


>A> AB INVAGEN PHARMS EQ 5MG BASE A204339 001 Jul 01, 2013 Jun NEWA

Page 15 of 19

ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL


>A> AB INVAGEN PHARMS EQ 10MG BASE

TABLET, ORALLY DISINTEGRATING; ORAL

A204339 002 Jul 01, 2013 Jun NEWA


>A> AB APOTEX INC EQ 5MG BASE A202477 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE A202477 002 Jul 01, 2013 Jun NEWA

>A> AB AUROBINDO PHARMA LTD EQ 5MG BASE A203062 001 Jul 01, 2013 Jun NEWA

>A> AB EQ 10MG BASE A203062 002 Jul 01, 2013 Jun NEWA >A> AB GLENMARK GENERICS EQ 5MG BASE A201914 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE A201914 002 Jul 01, 2013 Jun NEWA >A> AB NATCO PHARMA LTD EQ 5MG BASE A203478 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE A203478 002 Jul 01, 2013 Jun NEWA

>A> AB SANDOZ EQ 5MG BASE A078739 001 Jul 01, 2013 Jun NEWA >A> AB EQ 10MG BASE

SERTACONAZOLE NITRATE

A078739 002 Jul 01, 2013 Jun NEWA

CREAM; TOPICAL

ERTACZO

>D> + VALEANT INTL 2% NO21385 001 Dec 10, 2003 Jun CAHN >A> + VALEANT LUXEMBOURG 2%

SODIUM FLUORIDE F-18

NO21385 001 Dec 10, 2003 Jun CAHN

INJECTABLE; INTRAVENOUS

SODIUM FLUORIDE F-18

>A> + MCPRF 10-91.5MCl/ML A203605 001 Jun 28, 2013 Jun NEWA

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS


SODIUM PHOSPHATES IN PLASTIC CONTAINER

>D> HOSPIRA 142MG/ML;276MG/ML N018892 001 May 10, 1983 Jun CRLD

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS


SODIUM PHOSPHATES IN PLASTIC CONTAINER

>A> + HOSPIRA 142MG/ML;276MG/ML

SULFACETAMIDE SODIUM

N018892 001 May 10, 1983 Jun CRLD


SULFACETAMIDE SODIUM

>D> AT FERA PHARMS 10% A080029 001 Jun CAHN >A> AT PERRIGO CO TENNESSEE 10% A080029 001 Jun CAHN

SULFAMETHOXAZOLE; TRIMETHOPRIM

TABLET; ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

>D> AB SANDOZ 800MG;160MG N018598 004 May 19, 1982 Jun DISC >A> B 800MG;160MG

TACROLIMUS

N018598 004 May 19, 1982 Jun DISC

OINTMENT; TOPICAL

PROTOPIC

>ID> ASTELLAS 0.03% N050777 001 Dec 08, 2000 Jun CRLD >A>

>D>

0.03%

TILUDRONATE DISODIUM

N050777 001 Dec 08, 2000 Jun CRLD

>0> TABLET; ORAL

>D> SKELID

>0> + SANOFI AVENTIS US EQ 200MG BASE NO20707 001 Mar 07, 1997 Jun DISC >A> @ EQ 200MG BASE NO20707 001 Mar 07, 1997 Jur

Pagel6of19


TIMOLOL MALEATE

SOLUTION/DROPS; OPHTHALMIC

TIMOLOL MALEATE

>D> AT AKORN EQ 0.25% BASE A074515 001 Mar 25, 1997 Jun DISC

>A> @

TOPIRAMATE

EQ 0.25% BASE A074515 001 Mar 25, 1997 Jun DISC

TABLET; ORAL

TOPIRAMATE

>D> AB UPSHER SMITH 25MG A078499 001 Jan 07, 2010 Jun DISC

>A> @ 25MG A078499 001 Jan 07, 2010 Jun DISC >D> AB 50MG A078499 002 Jan 07, 2010 Jun DISC >A> 9 50MG A078499 002 Jan 07, 2010 Jun DISC >D> AB 100MG A078499 003 Jan 07, 2010 Jun DISC >A> 9 100MG A078499 003 Jan 07, 2010 Jun DISC >D> AB 200MG A078499 004 Jan 07, 2010 Jun DISC >A> 9

TOPOTECAN HYDROCHLORIDE

200MG A078499 004 Jan 07, 2010 Jun DISC


TOPOTECAN HYDROCHLORIDE

>A> AP ACCORD HLTHCARE

TRANEXAMIC ACID

EQ 4MG BASE/VIAL A202351 001 Jun 26, 2013 Jun NEWA


TRANEXAMIC ACID

>A> AP CUSTOPHARM INC

TRAZODONE HYDROCHLORIDE

100MG/ML A201580 001 Jun 14, 2013 Jun NEWA


OLEPTRO

>D> 8 ANGELINI LLC 150MG NO22411 001 Feb 02, 2010 Jun CMFD

>D> 9 300MG NO22411 002 Feb 02, 2010 Jun CMFD >A> + ANGELINI PHARMA 150MG NO22411 001 Feb 02, 2010 Jun CMFD >A>

>A> TREPROSTINIL

300MG NO22411 002 Feb 02, 2010 Jun CMFD

>A> INJECTABLE; IV (INFUSION)-SC

>A> REMODULIN

>A>

>D>

+ UNITED THERAP

TREPROSTINIL SODIUM

10MG/ML NO21272 004 May 21, 2002 Jun CAIN

>D> INJECTABLE; IV (INFUSION)-SC

>D> REMODULIN

>D> + UNITED THERAP

TRETINOIN

10MG/ML NO21272 004 May 21, 2002 Jun CAIN

CREAM; TOPICAL

RETIN-A

>A> AB + VALEANT BERMUDA 0.025% N019049 001 Sep 16, 1988 Jun CAHN

>A> AB1 + 0.05% N017522 001 Jun CAHN >A> AB + 0.1% N017340 001 Jun CAHN

>D> AB + VALEANT INTL 0.025% N019049 001 Sep 16, 1988 Jun CAHN

>D> AB1 + 0.05% N017522 001 Jun CAHN

>D> AB + 0.1% N017340 001 Jun CAHN

Page 17 of 19


TRIMETHOPRIM

TABLET; ORAL TRIMETHOPRIM

>D> + TEVA 200MG A071259 001 Jun 18, 1987 Jun DISC >A> 8

VALPROIC ACID

200MG A071259 001 Jun 18, 1987 Jun DISC

>D> CAPSULE, DELAYED RELEASE; ORAL >D> STAVZOR >D> BANNER PHARMACAPS 125MG NO22152 001 Jul 29, 2008 Jun DISC >A> @ 125MG NO22152 001 Jul 29, 2008 Jun DISC >D> 250MG NO22152 002 Jul 29, 2008 Jun DISC >A> @ 250MG NO22152 002 Jul 29, 2008 Jun DISC >0> + 500MG NO22152 003 Jul 29, 2008 Jun DISC >A> @

WARFARIN SODIUM

500MG NO22152 003 Jul 29, 2008 Jun DISC

TABLET; ORAL

WARFARIN SODIUM >A> AB IPCA LABS LTD 1MG A200104 001 Jun 27, 2013 Jun NEWA >A> AB 2MG A200104 002 Jun 27, 2013 Jun NEWA >A> AB 2.5MG A200104 003 Jun 27, 2013 Jun NEWA >A> AB 3MG A200104 004 Jun 27, 2013 Jun NEWA >A> AB 4MG A200104 005 Jun 27, 2013 Jun NEWA >A> AB 5MG A200104 006 Jun 27, 2013 Jun NEWA >A> AB 6MG A200104 007 Jun 27, 2013 Jun NEWA >A> AB 7.5MG A200104 008 Jun 27, 2013 Jun NEWA >A> AB 10MG A200104 009 Jun 27, 2013 Jun NEWA

Page 18 of 19

ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST

OMEPRAZOLE; SODIUM BICARBONATE

>A> FOR SUSPENSION; ORAL

>A> ZEGERID OTC

>A> + MSD CONSUMER 20MG/PACKET;1.68GM/PACKET NO22283 001 Jun 17, 2013 Jun

CURRENT MONTH ADDS/DELETES LIST NOTE:

The List is sorted by Ingredient(s) and, within each grouping, by the Dosage Form; Route and then by trade name.

The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date. The last two columns describe the action. The Action Month is the CS month the action occurred. The OB Action is the type of change that has occurred.

New ingredient(s), new dosage form; route(s), new trade names, and new product additions are

preceded by >A> during the action month. The change month is the current CS month; the change code for new approvals is NEWA.

Changes to currently listed products will list two records. The deleted product record will be proceeded by >D>. The product record change addition being made will be preceded by >A>.

The change code description:

NEWA New drug product approval usually in the supplement month.

CAHN Applicant holder firm name has changed.

CAIN Change. There has been a change in the Ingredient(s) name. All products will be deleted under the old name and all products will be added under the changed ingredient(s) name.

CDFR Change. Dosage Form; Route of Administration.

CFTG Change. A first time generic for the innovator product. A TE Code is added.

CMFD Change. The product is moved from the Discontinued Section due to a change in marketing status.

CMS1 Change. Miscellaneous addition to list.

CMS2 Change. Miscellaneous deletion from list.

CPOT Change. Potency amount/unit.

CRLD Change. Reference Listed Drug.

CTEC Change. Therapeutic Equivalence Code.

CTNA Change. Trade Name.

DISC Discontinued. The Rx or OTC listed product is not being marketed and will be moved to the discontinued section in the next edition.

Page 19 of 19