209531orig1s000 - food and drug administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209531Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209531Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 3: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 4: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 5: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 6: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 7: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 8: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 9: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 10: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 11: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 12: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19

WendyWilson- Lee

Digitally signed by Wendy Wilson- Lee

Date: 12/01/2016 01:49:55PM

GUID: 50816dbc000085595ca3284bbca465a8

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

Page 13: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 14: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 15: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 16: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19

MichaelFurness

Digitally signed by Michael Furness

Date: 11/23/2016 08 55:26AM

GUID: 502e8c7600003dd8331cf6eebf43697a

JamesLaurenson

Digitally signed by James Laurenson

Date: 11/22/2016 06 59:03PM

GUID: 51dc6bdb0000c62de59b85452e59746f

Page 17: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 18: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 19: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19

WendyWilson- Lee

Digitally signed by Wendy Wilson- Lee

Date: 12/01/2016 08 55:56AM

GUID: 50816dbc000085595ca3284bbca465a8

MariappanChelliah

Digitally signed by Mariappan Chelliah

Date: 12/01/2016 08 26:53AM

GUID: 5399cb2c00032b7c21877aa0d4d5f794

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

Page 20: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 21: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 22: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 23: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 24: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19

NealSweeney

Digitally signed by Neal Sweeney

Date: 11/18/2016 10:42:08AM

GUID: 508da70c00028f5119acd77351f33159

DeniseMiller

Digitally signed by Denise Miller

Date: 11/18/2016 10 37:45AM

GUID: 508da7280002a5d546459b998253d1aa

Page 25: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 26: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19
Page 27: 209531Orig1s000 - Food and Drug Administration · 2016 2016 2016 2016 2016 2016 2016 2016 -2016 2016 2016 2016 2016 2016 2016 2016 2016 2016 Ori -Part 2 SD 7 SD 8 SD 12 SD 18 SD 19