CENTER FOR DRUG EVALUATION AND RESEARCH · The Chemistry Review for NDA 202450 The Executive Summary I. Recommendations A. Recommendation and Conclusion on Approvability This NDA

CENTER FOR DRUG EVALUATION AND

RESEARCH

APPLICATION NUMBER:

204623Orig1s000

CHEMISTRY REVIEW(S)

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

YONG HU02/08/2013

PRASAD PERI02/08/2013I concur

Reference ID: 3258383

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

YONG HU02/01/2013Corrected version.

PRASAD PERI02/01/2013I concur

Reference ID: 3254049