211996orig1s000 212161orig1s000 · 2019. 6. 13. · date: 4/04/2019 11:02:18am guid:...
TRANSCRIPT
![Page 1: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
211996Orig1s000 212161Orig1s000
PRODUCT QUALITY REVIEW(S)
![Page 2: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/2.jpg)
![Page 3: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/3.jpg)
![Page 4: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/4.jpg)
![Page 5: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/5.jpg)
![Page 6: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/6.jpg)
![Page 7: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/7.jpg)
![Page 8: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/8.jpg)
![Page 9: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/9.jpg)
![Page 10: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/10.jpg)
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
![Page 11: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/11.jpg)
![Page 12: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/12.jpg)
![Page 13: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/13.jpg)
![Page 14: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/14.jpg)
![Page 15: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/15.jpg)
![Page 16: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/16.jpg)
![Page 17: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/17.jpg)
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)
![Page 18: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/18.jpg)
![Page 19: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/19.jpg)
![Page 20: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/20.jpg)
![Page 21: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/21.jpg)
![Page 22: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/22.jpg)
![Page 23: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/23.jpg)
![Page 24: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/24.jpg)
![Page 25: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/25.jpg)
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
![Page 26: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/26.jpg)
WendyWilson- Lee
Digitally signed by Wendy Wilson- LeeDate: 3/29/2019 10:10:26AMGUID: 50816dbc000085595ca3284bbca465a8
![Page 27: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/27.jpg)
![Page 28: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/28.jpg)
![Page 29: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/29.jpg)
![Page 30: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/30.jpg)
![Page 31: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/31.jpg)
![Page 32: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/32.jpg)
![Page 33: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/33.jpg)
![Page 34: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/34.jpg)
![Page 35: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/35.jpg)
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
![Page 36: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/36.jpg)
![Page 37: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/37.jpg)
![Page 38: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/38.jpg)
![Page 39: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/39.jpg)
![Page 40: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/40.jpg)
![Page 41: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/41.jpg)
![Page 42: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/42.jpg)
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
![Page 43: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/43.jpg)
![Page 44: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/44.jpg)
![Page 45: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/45.jpg)
![Page 46: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/46.jpg)
![Page 47: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/47.jpg)
![Page 48: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/48.jpg)
![Page 49: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/49.jpg)
![Page 50: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/50.jpg)
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
![Page 51: 211996Orig1s000 212161Orig1s000 · 2019. 6. 13. · Date: 4/04/2019 11:02:18AM GUID: 5575db68006e2262805f2e6449c54250 Jing Li Digitally signed by Jing Li Date: 4/04/2019 11:49:27AM](https://reader036.vdocuments.us/reader036/viewer/2022071509/6129f13cec13423a8135a964/html5/thumbnails/51.jpg)
WendyWilson- Lee
Digitally signed by Wendy Wilson- LeeDate: 4/05/2019 11:03:16AMGUID: 50816dbc000085595ca3284bbca465a8