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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208418Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208418Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 3: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 4: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 5: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 6: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 7: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 8: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 9: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 10: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
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Page 12: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 13: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 14: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 15: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika

An-ChiLu

Digitally signed by An-Chi Lu

Date: 4/07/2017 03:38:58PM

GUID: 508da73f0002b8f58e8154431f048ac2

HarithaMandula

Digitally signed by Haritha Mandula

Date: 4/17/2017 12:43:11PM

GUID: 508da6fb000282df41459408f32a1ce0

Page 16: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 17: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 18: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 19: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 20: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 21: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika

NealSweeney

Digitally signed by Neal Sweeney

Date: 1/16/2017 03:11:15PM

GUID: 508da70c00028f5119acd77351f33159

YuanshaChen

Digitally signed by Yuansha Chen

Date: 1/16/2017 09:55:13AM

GUID: 545289f5000727e1136ef94794e114b8

Page 22: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 23: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika
Page 24: 208418Orig1s000 - accessdata.fda.gov · lication Technical Lead API Thug Product Process Facili Bio harmaceutics Microbiolo Quality Review Data Sheet uali Review Team REVIEWER Anika

Su (Suong)Tran

Digitally signed by Su (Suong) Tran

Date: 5/15/2017 11:18:02AM

GUID: 508da71f00029ec8b75e233f12b15339


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