product quality review(s)...one drop topically in the eye(s) as needed. see package insert for the...

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210821Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

210821Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 4: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 5: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 6: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 7: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 8: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 9: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 10: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Lixia Date: 3/01/2019 09:09:19AMDigitally signed by Lixia Cai

Cai GUID: 5991ca70005dd721555f4929e671d9bd

Daniel Digitally signed by Daniel Obrzut Date: 3/01/2019 09:28:45AMObrzut GUID: 53b42ae400012153536b67870145b81e

Reference ID: 4404862

Page 11: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Chunchun Digitally signed by Chunchun Zhang Date: 3/01/2019 09:58:31AMZhang GUID: 51269608000064178e75377202fe6c5d

Reference ID: 4404862

Page 12: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 13: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 14: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 15: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 16: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 17: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 18: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Rajan Digitally signed by Rajan Pragani Date: 9/12/2018 12:24:06PMPragani GUID: 578e502f005503985deca4ae5b7e95fa

Su (Suong) Digitally signed by Su (Suong) Tran Date: 9/12/2018 01:07:49PMTran GUID: 508da71f00029ec8b75e233f12b15339

53 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page

Reference ID: 4404862

Page 19: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 20: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Qi Zhang

Jing Li

Date: 10/25/2018 02:09:28PMDigitally signed by Qi Zhang

GUID: 547e178000007695c91eb10380b07939

Date: 10/25/2018 02:47:08PMDigitally signed by Jing Li

GUID: 508da7420002bb05ac913303b23c39bb

7 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page

Reference ID: 4404862

Page 21: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 22: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 23: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 24: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Page 25: Product Quality Review(s)...One drop topically in the eye(s) as needed. See package Insert for the recommended dosa e m atients. As above (see the package inselt for details). B. Reference

Renee Digitally signed by Renee Marcsisin Date: 8/01/2018 03:47:23PMMarcsisin GUID: 58a215b40087203411c81698f83c8632

Jesse Digitally signed by Jesse Wells Date: 8/01/2018 03:46:27PMWells GUID: 508da70b00028ea901ac6652677f7d00

Reference ID: 4404862

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