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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208271Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208271Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 3: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 4: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 5: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 6: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 7: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
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Page 9: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
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Page 22: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
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Page 27: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 28: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 29: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 30: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 31: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
Page 32: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
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Page 37: 208271Orig1s000 - Food and Drug Administration · 2017-11-17 · 19-JUN-2015 25-NOV-2015 20-JAN-2016 19-JUN-2015 20 Jan 2016 12 December 2015 24 Feb 2016 10 March, 2016 Quali Review
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