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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
209360Orig1s000
PRODUCT QUALITY REVIEW(S)
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MohanSapru
Digitally signed by Mohan SapruDate: 12/11/2017 09:34:26AMGUID: 504f821600000ec6d20b59d2b68eb3d2
88 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
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RaoKambhampati
Digitally signed by Rao KambhampatiDate: 11/30/2017 10:51:22AMGUID: 508da72000029fd06e8c9283b7414189
WendyWilson- Lee
Digitally signed by Wendy Wilson- LeeDate: 11/30/2017 10:53:18AMGUID: 50816dbc000085595ca3284bbca465a8
22 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
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GerlieGieser
Digitally signed by Gerlie GieserDate: 11/27/2017 09:35:45AMGUID: 507592ba00003d190b2ea34fe8fb8ccb
JingLi
Digitally signed by Jing LiDate: 11/27/2017 11:37:27AMGUID: 508da7420002bb05ac913303b23c39bb
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JianliXue
Digitally signed by Jianli XueDate: 12/08/2017 08:57:12AMGUID: 584afcd70041453da94854122880ab0c
NandiniBhattacharya
Digitally signed by Nandini BhattacharyaDate: 12/08/2017 11:08:23AMGUID: 508da70c00028f454473851fced0e9d4
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MohanSapru
Digitally signed by Mohan SapruDate: 12/11/2017 10:01:49AMGUID: 504f821600000ec6d20b59d2b68eb3d2