209139orig1s000...mohan sapru digitally signed by mohan sapru date: 10/13/2017 11:32:30am guid:...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209139Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209139Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 3: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 4: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 5: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 6: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 7: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 8: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 9: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 10: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 11: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS

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

Page 12: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 13: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 14: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 15: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS

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

Page 16: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 17: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 18: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 19: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 20: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 21: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 22: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS
Page 23: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS

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

Page 24: 209139Orig1s000...Mohan Sapru Digitally signed by Mohan Sapru Date: 10/13/2017 11:32:30AM GUID: 504f821600000ec6d20b59d2b68eb3d2 31 Page(s) has been Withheld in Full as b4 (CCI/TS

MohanSapru

Digitally signed by Mohan SapruDate: 10/13/2017 11:54:05AMGUID: 504f821600000ec6d20b59d2b68eb3d2