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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209637Orig1s000 PRODUCT QUALITY REVIEW(S)

209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

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Page 1: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209637Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 3: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 4: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 5: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 6: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 7: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 8: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 9: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 10: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 11: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 12: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
Page 13: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

ElizabethBearr

Digitally signed by Elizabeth Bearr

Date: 7/25/2017 10:11:34AM

GUID: 55370d1e00cfd67fc04d8bfbedbf3096

ErikaPfeiler

Digitally signed by Erika Pfeiler

Date: 7/25/2017 10:12:40AM

GUID: 502d1da500002b6a73a00c0e0dff6e1d

Page 14: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical
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Su (Suong)Tran

Digitally signed by Su (Suong) Tran

Date: 7/27/2017 04:13:30PM

GUID: 508da71f00029ec8b75e233f12b15339


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