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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208547Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208547Orig1s000...Executive Summary I. Recommendations APPROVAL A. Recommendation and Conclusion on Approvability 1. Summary of Complete Response issues ... Bateman, David ADEQUATE

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208547Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208547Orig1s000...Executive Summary I. Recommendations APPROVAL A. Recommendation and Conclusion on Approvability 1. Summary of Complete Response issues ... Bateman, David ADEQUATE
Page 3: 208547Orig1s000...Executive Summary I. Recommendations APPROVAL A. Recommendation and Conclusion on Approvability 1. Summary of Complete Response issues ... Bateman, David ADEQUATE
Page 4: 208547Orig1s000...Executive Summary I. Recommendations APPROVAL A. Recommendation and Conclusion on Approvability 1. Summary of Complete Response issues ... Bateman, David ADEQUATE
Page 5: 208547Orig1s000...Executive Summary I. Recommendations APPROVAL A. Recommendation and Conclusion on Approvability 1. Summary of Complete Response issues ... Bateman, David ADEQUATE
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Application Technical Lead: Eldon E. Leutzinger, Ph.D., CMC Lead

Eldon E. Leutzinger -A

Digitally signed by Eldon E. Leutzinger -A DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300054329, cn=Eldon E. Leutzinger -A Date: 2016.05.02 08:39:15 -04'00'

(b) (4)

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