211996orig1s000 212161orig1s000 · 2019. 6. 13. · date: 4/04/2019 11:02:18am guid:...

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

211996Orig1s000 212161Orig1s000

PRODUCT QUALITY REVIEW(S)

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 3/28/2019 03:31:37PMGUID: 50816dbc000085595ca3284bbca465a8

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

MariappanChelliah

Digitally signed by Mariappan ChelliahDate: 3/27/2019 04:01:36PMGUID: 5399cb2c00032b7c21877aa0d4d5f794

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 3/27/2019 04:17:51PMGUID: 50816dbc000085595ca3284bbca465a8

(b) (4)

KaushalkumarDave

Digitally signed by Kaushalkumar DaveDate: 3/21/2019 10:03:46AMGUID: 5575db68006e2262805f2e6449c54250

JingLi

Digitally signed by Jing LiDate: 3/21/2019 10:17:33AMGUID: 508da7420002bb05ac913303b23c39bb

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 3/29/2019 10:10:26AMGUID: 50816dbc000085595ca3284bbca465a8

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 4/05/2019 08:52:33AMGUID: 50816dbc000085595ca3284bbca465a8

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

MariappanChelliah

Digitally signed by Mariappan ChelliahDate: 3/27/2019 03:59:48PMGUID: 5399cb2c00032b7c21877aa0d4d5f794

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 3/27/2019 04:17:48PMGUID: 50816dbc000085595ca3284bbca465a8

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

KaushalkumarDave

Digitally signed by Kaushalkumar DaveDate: 4/04/2019 11:02:18AMGUID: 5575db68006e2262805f2e6449c54250

JingLi

Digitally signed by Jing LiDate: 4/04/2019 11:49:27AMGUID: 508da7420002bb05ac913303b23c39bb

WendyWilson- Lee

Digitally signed by Wendy Wilson- LeeDate: 4/05/2019 11:03:16AMGUID: 50816dbc000085595ca3284bbca465a8