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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208745Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208745Orig1s000 - Food and Drug Administration athic consti ation. DOCUMENT 2. CONSULTS: None DISCIPLINE Biostatistics Phannacolo /Toxicolo CDRH Clinical APPLICATION NUMBER 74883 RECOMMENDATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208745Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208745Orig1s000 - Food and Drug Administration athic consti ation. DOCUMENT 2. CONSULTS: None DISCIPLINE Biostatistics Phannacolo /Toxicolo CDRH Clinical APPLICATION NUMBER 74883 RECOMMENDATION
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Attachment 1:

Labeling:

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HiteshShroff

Digitally signed by Hitesh Shroff

Date: 1/12/2017 02:33:27PM

GUID: 502d1ab500002afd219fd67e3b9c99c8

APPEARS THIS WAY ON ORIGINAL

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JuandriaWilliams

Digitally signed by Juandria Williams

Date: 11/22/2016 02 37:12PM

GUID: 513b65ab0005b7cb48614cd3d341d717

VidyaPai

Digitally signed by Vidya Pai

Date: 11/22/2016 02 51:29PM

GUID: 53b581d20000464509a65e37ec9ad4a2

APPEARS THIS WAY ON ORIGINAL

Page 9: 208745Orig1s000 - Food and Drug Administration athic consti ation. DOCUMENT 2. CONSULTS: None DISCIPLINE Biostatistics Phannacolo /Toxicolo CDRH Clinical APPLICATION NUMBER 74883 RECOMMENDATION
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Moo JhongRhee

Digitally signed by Moo Jhong Rhee

Date: 9/30/2016 12:24:50PM

GUID: 502d0913000029f9798ca689a802fa55

ZhengfangGe

Digitally signed by Zhengfang Ge

Date: 9/30/2016 12:07:39PM

GUID: 508da7210002a030e76df4f60ccd142a

34 Page(s) have been Withheld in Full as b4 (CCI/TS) immediately following this page

APPEARS THIS WAY ON ORIGINAL

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Tien MienChen

Digitally signed by Tien Mien Chen

Date: 10/04/2016 02:12:20PM

GUID: 508da7240002a26723d38018ce005126

KalpanaPaudel

Digitally signed by Kalpana Paudel

Date: 10/04/2016 01 39:37PM

GUID: 562e1e15002f200f35c6ccac959cdb34

APPEARS THIS WAY ON ORIGINAL

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HiteshShroff

Digitally signed by Hitesh Shroff

Date: 10/06/2016 08:43:16PM

GUID: 502d1ab500002afd219fd67e3b9c99c8

APPEARS THIS WAY ON ORIGINAL


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