Drugs@FDA: FDA-Approved Drugs

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

• Medication Guide

• Summary Review

Products on NDA 22350

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONGLYZA	SAXAGLIPTIN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ONGLYZA	SAXAGLIPTIN HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 022350

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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