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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 211996Orig1s000 212161Orig1s000 PRODUCT QUALITY REVIEW(S)

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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

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
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
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
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
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
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
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
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
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

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
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
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
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
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
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
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

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
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
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
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
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
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
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
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

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

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
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
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
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
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
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
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
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
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

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
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
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
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
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
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
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

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
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
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
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
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
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
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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

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WendyWilson- Lee

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


Guang Li, Jing Li, and Xiangkui Hanijesd.org/papers/416-G3014.pdf · 2015. 2. 14. · Jing Li is with Jilin Jian Yuan Design Group fifth Institute, Changchun, China (e-mail: [email protected])

Michael Murphy, Gwynneth Davidoff, Jing Li, Michael Sullivan

Jing-hua Li Zhejiang Gongshang University P.R.China 02/06/2008

Li Simin, Cong Rong, Yao Xiaoxiao, Feng Jing, Tang

Hui Li and Jing Li - Atlantis Press

SECTION I: Multiple Choiceeall.hawaii.edu/yao/Kaohsiung2011/NanhaiAP/NanhaiBook/AP...A) Dawei’s parents have met Li Jing before. B) Li Jing knows how to get to Dawei’s house. C)

Nick Beauchamp, Lu Wang, Jing Li, Sarah Shugarsweb.northeastern.edu/nulab/wp-content/uploads/2017/... · Nick Beauchamp, Lu Wang, Jing Li, Sarah Shugars Keeping the Public Sphere

Li-Jing WANG - Atlantis Press

LI jia-jing Portfolio

CASE STUDY: LI JING - COTA Australia · 2019. 6. 7. · CASE STUDY: LI JING Li Jing, aged 76, is proud of her Chinese heritage and sees herself as the family matriarch. She had been

Elizabeth Cheng | Jing-Jing Li | Irwin Liu | Jessica Lukrichgiacomoballi.com/pdf/Square_Pitch_deck.pdf · Index of Presentation and Appendix Slides Presentation Slides Appendix Slides

Jing LI City University of Hong Kong · Jing LI City University of Hong Kong ... they deal with the user cost of housing for individual households with some lowest standard,

Li-jing, Libro de Los Ritos I

Ning Li, Xiaofeng Meng, Jing Nie ,andLiweiLin

Ch0624李烔沛jing pei li

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Kong Xiao-mu Zhang Jing-jie Li Nan

Progress of CMA TIGGE Archive Data center (updated) Bian Xiaofeng,Li Xiang,Sun Jing (National Meteorological Information Centre,CMA) Chen Jing Hu Jiangkai,

GROUP SEVEN Li Song Jing(Jennifer) Xu Xiaoshuang Du · FINAL PROJECT GROUP SEVEN Li Song Jing(Jennifer) Xu Xiaoshuang Du . 2 Contents ... Doing the final project was a journey of

Let's Practice It! Gr2 SE · 2018. 10. 17. · 1. The boat rocked back and forth. Jing Li felt a little dizzy on the waves. Where is Jing Li? 2. Jing Li’s dad said, “Hold on

#BTO2011 - B[R]IC - Jing Li

, Xin Li , Caili Wu , Shuchen Kong , Jing Yang , Liang He · Xiaowen Shiy, Xin Li yz, Caili Wu , Shuchen Kong?, Jing Yangy, Liang Heyz zShanghai Key Laboratory of Multidimensional

Maohua Li – Zéman Zoltán – Jing Li

《深圳统计年鉴—2017》编委会名单 · chairman：yang xin hong jia jing zhi ... li bo wei li jie mai xue fei chen jun hong chen jun lin chen dan dan yu xue jing zhou li

Jing Li, Mark Thyer, Martin Lambert, George Kuczera ......ACCEPTED VERSION Jing Li, Mark Thyer, Martin Lambert, George Kuczera, Andrew Metcalfe An efficient causative event-based approach

Jing Zhang, Wanqing Li, Philip Ogunbona · 2018. 1. 23. · Results on Cross- domain Object Recognition (surf) Results on Real World Data Jing Zhang, Wanqing Li, Philip Ogunbona

Li Zunxiang, Jiao Jing*, Wang Shuo, Du Jihua, Huang

Composite Materials Dr. Jing LI 13661954020 55271689 [email protected] 2014-2015 Fall Semester

Review Article Historical Perspective of Traditional ...ancient Chinese scripts, such as Shang-Shu , Shi-Jing ( e book of songs), Shan-Hai-Jing , Zhou-Li , Li-Ji ( e book of rites),

Nick Beauchamp, Lu Wang, Jing Li, Sarah Shugars · Nick Beauchamp, Lu Wang, Jing Li, Sarah Shugars Keeping the Public Sphere Open NULabSpring Conference, Northeastern University March

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