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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210498Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

210498Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 3: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 4: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 5: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 6: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 7: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 8: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 9: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 10: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 11: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 12: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 13: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated

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Page 14: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 15: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 16: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 17: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 18: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 19: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated

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52 Page(s) have been Withheld in Full as B4 (CCI/TS) immediately following this page

Page 20: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 21: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 22: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 23: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated
Page 24: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated

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Digitally signed by Zhuojun ZhaoDate: 2/14/2018 05:08:47PMGUID: 508da6fd000284770cf4eecbae074722

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Page 25: 210498Orig1s000 - Food and Drug Administration...441.23 g/mole Binimetinib is an achiral small molecule in white to slightly yellow powder which is non-hygroscopic. It is isolated

NinaNi

Digitally signed by Nina NiDate: 2/27/2018 03:58:03PMGUID: 502d1ab500002afbbe642f8f37136920


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