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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200678
Company: ASTRAZENECA AB

Medication Guide

Summary Review

Products on NDA 200678

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200678

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2010	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200678s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678_kombiglyze_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2019	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004, 210874Orig1s001ltr.pdf
01/18/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf
01/18/2017	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf
02/27/2017	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf
08/28/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf
02/09/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/05/2016	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf
05/24/2013	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200678Orig1s010ltr.pdf
11/08/2012	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/01/2012	SUPPL-7	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s007ltr.pdf
11/15/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200678s005ltr.pdf
03/07/2012	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf
03/07/2012	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf
05/15/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 200678

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf
02/27/2017	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf
01/18/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf
01/18/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf
04/05/2016	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf
08/28/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf
05/24/2013	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf
03/07/2012	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf
03/07/2012	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf
11/15/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf
11/05/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf

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