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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022350
Company: ASTRAZENECA AB

Medication Guide

Summary Review

Products on NDA 022350

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONGLYZA	SAXAGLIPTIN HYDROCHLORIDE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ONGLYZA	SAXAGLIPTIN HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022350

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022350lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022350s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2024	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022350s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022350Orig1s026, 200678Orig1s028ltr.pdf
07/01/2019	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004, 210874Orig1s001ltr.pdf
01/18/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s019ltr.pdf
02/27/2017	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf
11/25/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/28/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf
04/05/2016	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022350s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf
01/23/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
05/24/2013	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022350Orig1s011ltr.pdf
03/13/2012	SUPPL-9	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022350s009ltr.pdf
11/15/2011	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s007ltr.pdf
12/16/2011	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s004ltr.pdf
02/18/2011	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf
02/18/2011	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf

Labels for NDA 022350

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2024	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022350s026lbl.pdf
07/01/2019	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf
02/27/2017	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf
01/18/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s019lbl.pdf
04/05/2016	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022350s014lbl.pdf
08/28/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf
05/24/2013	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf
12/16/2011	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf
11/15/2011	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007lbl.pdf
02/18/2011	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf
02/18/2011	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf
07/31/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022350lbl.pdf

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