208547orig1s000...executive summary i. recommendations approval a. recommendation and conclusion on...
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CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
208547Orig1s000
CHEMISTRY REVIEW(S)
17
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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