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

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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 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

Page 15: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Su (Suong)Tran

Digitally signed by Su (Suong) Tran

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

GUID: 508da71f00029ec8b75e233f12b15339

Original Article MicroRNA profile changes in liraglutide ...Original Article MicroRNA profile changes in liraglutide treated steatotic HepG2 cells Yunfeng Shen 1,2, Meimei Liu , Chao

LEADER: Liraglutide VICTOZA CV Outcomes Trial Summary · RXFILES TRIAL SUMMARY JULY 2016; UPDATED MAY 2017 – Page 1 of 3 LEADER: Liraglutide VICTOZA CV Outcomes Trial Summary1 Liraglutide:

HIGHLIGHTS OF PRESCRIBING INFORMATION - novo-pi.com · Saxenda ® liraglutide) njection 2 FULL PRESCRIBING INFORMATION WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide causes

Theory of HPLC Quantitative and Qualitative HPLC

Package Leaflet: Information for the User Liraglutide 6mg/ml … · 2021. 1. 4. · Package Leaflet: Information for the User Liraglutide 6mg/ml Solution for injection in pre-filled

125431Orig1s000 - accessdata.fda.gov

Liraglutide protects from renal damage via Akt-mTOR pathway in … · 2019-08-07 · 117 Abstract. – OBJECTIVE: To explore the pro- tective effect of liraglutide on renal damage

Liraglutide as Additional Tt tiT 1DibtTreatment in Type 1 ...€¦ · Liraglutide as Additional Tt tiT 1DibtTreatment in Type 1 Diabetes Ajay Varanasi, Natalie Bellini, Deepti Rawal,

Liraglutide in Type 2 Diabetes Mellitus: Clinical ...ment of type 2 diabetes. Among the large number of clinical pharmacology studies published on liraglutide, this updated review

Attachment: Product Information: Liraglutide...Attachment 1: Product information AusPAR VICTOZA, SAXENDA liraglutide Novo Nordisk Pharmaceuticals Pty. Ltd. -PM-2016-003931-1-5 -FINAL

Jan 03, 2014 · Ethyl Acetate n-Butyl Acetate Acetone N-Methyl-2-pyrrolidone Tetrahydrofuran Tetrahydrofuran Ethyl Ether Methyl t-Butyl Ether Grade HPLC HPLC HPLC HPLC HPLC HPLC

HPLC Instrumentation, Pharmaceutical analysis, HPLC detectorsInstmn sem sharu(4)

Is Xultophy (insulin degludec/liraglutide) a match … › __media › ...Xultophy® Insulin degludec and Liraglutide. Please consult the full Summary of Product Characteristics (SmPC)

Victoza (Liraglutide) Solution for Injection - PAXpress

Analytical HPLC Columns - Webscapa-chem.webs.com/Industrial Spnosors/2012-8... · Ultisil® HPLC Columns Analytical HPLC Columns ... We offer a full line of HPLC columns to meet HPLC

The GLP-1 agonist, liraglutide, ameliorates inflammation ......RESEARCH Open Access The GLP-1 agonist, liraglutide, ameliorates inflammation through the activation of the PKA/CREB

HPLC Systems. Column Chromatography HPLC Modes HPLC – System Components

Contribution of Liraglutide in the Fixed-Ratio Combination ... · Fixed-Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) ... OBJECTIVE Insulin degludec/liraglutide

203791Orig1s000 - accessdata.fda.gov

HPLC SYSTEM S 500 SERIES - Sykamsykam.com/wp-content/uploads/HPLC-System-S500-web.pdf · The Sykam HPLC System S 500 Series ... analytical tasks in HPLC and GPC. S 1125 HPLC PUMP

208054Orig1s000 - accessdata.fda.gov

Liraglutide for the treatment of diabetes mellitus in Japan...blood glucose (area under the curve [AUC] glucose, 0–24h /24) in patients receiving liraglutide was 20% lower in the

Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical

HPLC Workshop - University College Dublin HPLC Workshop.pdf · HPLC Introduction: HPLC = improved form of column chromatography Instead of the mobile phase moving through the

ABCD Nationwide Exenatide and Liraglutide Audits · ABCD Nationwide Exenatide and Liraglutide Audits Dr Bob Ryder and Professor Stephen Gough on behalf of the ABCD nationwide exenatide

HPLC PPT High Performance Liquid Chromatography (HPLC) PPT, Presentation

99% by HPLC 97% by HPLC 98% – 102% by HPLC

The GLP-1 Analogs Liraglutide and Semaglutide Reduce ... · The GLP-1 Analogs Liraglutide and Semaglutide Reduce Atherosclerosis in ApoE / and LDLr / Mice by a Mechanism That Includes

Capillary HPLC Introduction Capillary HPLC Liquid chromatography

liraglutide and sitagliptin in experimentally model of NF

Combination Therapy of Seladelpar and Liraglutide Attenuates Obesity… · 2019-06-24 · Combination Therapy of Seladelpar and Liraglutide Attenuates Obesity, Hepatic Steatosis and

Cool Brands Direct...Product name Plus cbd oil original spray peppermint Batch/Lot#: 7151310 Strength: loz 100mg Analyst: VK JUN 2017 Method: HPLC HPLC HPLC HPLC HPLC …

Liraglutide Activates the Nrf2/HO-1 Antioxidant Pathway and …downloads.hindawi.com/journals/cin/2018/3094504.pdf · ResearchArticle Liraglutide Activates the Nrf2/HO-1 Antioxidant

GLP-1 e Sistema Cardiovascolare: Fisiologia - Giorgino Francesco... · Effect of 1-week treatment with liraglutide (30 µg/kg) in mice fed on 45% high-fat diet: Liraglutide Reduced

Attachment: Product Information: Liraglutide · Web viewAttachment 1: Product information AusPAR VICTOZA, SAXENDA liraglutide Novo Nordisk Pharmaceuticals Pty. Ltd. - PM-2016-003931-1-5