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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
209139Orig1s000
PRODUCT QUALITY REVIEW(S)
MohanSapru
Digitally signed by Mohan SapruDate: 10/13/2017 11:32:30AMGUID: 504f821600000ec6d20b59d2b68eb3d2
31 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
MariappanChelliah
Digitally signed by Mariappan ChelliahDate: 10/03/2017 09:44:06AMGUID: 5399cb2c00032b7c21877aa0d4d5f794
WendyWilson- Lee
Digitally signed by Wendy Wilson- LeeDate: 10/03/2017 09:52:03AMGUID: 50816dbc000085595ca3284bbca465a8
21 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
NealSweeney
Digitally signed by Neal SweeneyDate: 7/12/2017 08:44:37PMGUID: 508da70c00028f5119acd77351f33159
DeniseMiller
Digitally signed by Denise MillerDate: 7/12/2017 02:11:06PMGUID: 508da7280002a5d546459b998253d1aa
MohanSapru
Digitally signed by Mohan SapruDate: 10/13/2017 11:54:05AMGUID: 504f821600000ec6d20b59d2b68eb3d2