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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202270
Company: MSD SUB MERCK

Medication Guide

Summary Review

Products on NDA 202270

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202270

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270_janumet_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2022	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021995Orig1s050, 022044Orig1s052, 202270Orig1s026ltr.pdf
11/04/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202270s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202270Orig1s025ltr.pdf
12/04/2020	SUPPL-22	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021995Orig1s047; 022044Orig1s048; 202270Orig1s022ltr.pdf
07/01/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s046, 022044Orig1s047, 202270Orig1s020ltr.pdf
08/12/2019	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s045, 202270Orig1s019, 022044Orig1s046.ltr.pdf
02/09/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf
08/10/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf
01/18/2017	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf
01/18/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf
08/28/2015	SUPPL-10	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf
04/27/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf
09/19/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/12/2014	SUPPL-6	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202270Orig1s006ltr.pdf
10/17/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/19/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/11/2013	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202270Orig1s003ltr.pdf
10/18/2012	SUPPL-2	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270Orig1s002ltr.pdf
04/10/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 202270

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2022	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf
11/04/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202270s025lbl.pdf
12/04/2020	SUPPL-22	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf
08/12/2019	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s019lbl.pdf
07/01/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s020lbl.pdf
02/09/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf
08/10/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf
01/18/2017	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf
01/18/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf
01/18/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf
08/28/2015	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf
04/27/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf
02/12/2014	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf
02/11/2013	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf
02/11/2013	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf
10/18/2012	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf
02/02/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf

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