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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209176Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209176Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 3: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 4: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 5: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 6: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 7: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 8: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

WendyWilson- Lee

Digitally signed by Wendy Wilson- Lee

Date: 1/19/2017 03:11:27PM

GUID: 50816dbc000085595ca3284bbca465a8

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

Page 9: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 10: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 11: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 12: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 13: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 14: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 15: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

WendyWilson- Lee

Digitally signed by Wendy Wilson- Lee

Date: 1/19/2017 04:26:18PM

GUID: 50816dbc000085595ca3284bbca465a8

DanBerger

Digitally signed by Dan Berger

Date: 1/19/2017 04:25:54PM

GUID: 56e6e1b5001a2fedae663c62a5ce7513

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

Page 16: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 17: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 18: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 19: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 20: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 21: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 22: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 23: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

ErikaPfeiler

Digitally signed by Erika Pfeiler

Date: 12/05/2016 12:10:49PM

GUID: 502d1da500002b6a73a00c0e0dff6e1d

EricAdeeku

Digitally signed by Eric Adeeku

Date: 12/05/2016 10:12 06AM

GUID: 508da70b00028e3db199467cfbd47cb0

Page 24: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 25: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 26: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

Page 27: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

WendyWilson- Lee

Digitally signed by Wendy Wilson- Lee

Date: 1/19/2017 03:02:54PM

GUID: 50816dbc000085595ca3284bbca465a8

Page 28: 209176Orig1s000 - Food and Drug Administration · 2017. 6. 19. · Wendy Wilson- Lee Digitally signed by Wendy Wilson- Lee Date: 1/19/2017 03:11:27PM GUID: 50816dbc000085595ca3284bbca465a8

WendyWilson- Lee

Digitally signed by Wendy Wilson- Lee

Date: 1/19/2017 04:39:40PM

GUID: 50816dbc000085595ca3284bbca465a8

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