CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208418Orig1s000

PRODUCT QUALITY REVIEW(S)

An-ChiLu

Digitally signed by An-Chi Lu

Date: 4/07/2017 03:38:58PM

GUID: 508da73f0002b8f58e8154431f048ac2

HarithaMandula

Digitally signed by Haritha Mandula

Date: 4/17/2017 12:43:11PM

GUID: 508da6fb000282df41459408f32a1ce0

NealSweeney

Digitally signed by Neal Sweeney

Date: 1/16/2017 03:11:15PM

GUID: 508da70c00028f5119acd77351f33159

YuanshaChen

Digitally signed by Yuansha Chen

Date: 1/16/2017 09:55:13AM

GUID: 545289f5000727e1136ef94794e114b8

Su (Suong)Tran

Digitally signed by Su (Suong) Tran

Date: 5/15/2017 11:18:02AM

GUID: 508da71f00029ec8b75e233f12b15339