Janumet

For type 2 diabetes mellitus. NDA 22044, held by Msd Sub Merck. Metformin Hydrochloride; Sitagliptin Phosphate.

As of Nov 15, 2026, NDA 22044 (Janumet), held by Msd Sub Merck, was first approved by FDA on Mar 30, 2007, with 36 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2007
Review: Standard
Supplements approved: 36
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUMET should not be used in patients with type 1 diabetes mellitus. JANUMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below


Dec 4, 2020	Supplement 48Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 12, 2019	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 24, 2010	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2008	Supplement 4Efficacy (new indication or use)	Approved	Letter Label
Feb 26, 2008	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Mar 30, 2007	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Janumet500MG;EQ 50MG BASE · tablet;oral	Metformin Hydrochloride; Sitagliptin Phosphate	RxReference drug
Janumet1GM;EQ 50MG BASE · tablet;oral	Metformin Hydrochloride; Sitagliptin Phosphate	RxReference drug

All 37 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 58Labeling	Approved	Label Medication Guide Letter
Jun 21, 2022	Supplement 52Labeling · Standard review	Approved	Label Letter
Nov 4, 2021	Supplement 51Labeling · Standard review	Approved	Label Letter
Dec 4, 2020	Supplement 48Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 12, 2019	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 1, 2019	Supplement 47Labeling	Approved	Label Letter
Feb 9, 2018	Supplement 43Labeling · Standard review	Approved	Letter Label
Aug 10, 2017	Supplement 42Labeling · Standard review	Approved	Letter Label
Jan 18, 2017	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 18, 2017	Supplement 39Labeling	Approved	Letter Label
Aug 28, 2015	Supplement 35Labeling	Approved	Label Letter
Jun 12, 2015	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 27, 2015	Supplement 34Labeling · Standard review	Approved	Label Letter
Jan 5, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Mar 18, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 11, 2013	Supplement 29Labeling · Standard review	Approved	Letter Label
Jun 28, 2013	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 7, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 18, 2012	Supplement 26Labeling	Approved	Letter Label
Mar 24, 2012	Supplement 22Labeling	Approved	Label Letter
Jun 10, 2011	Supplement 15Labeling	Approved	Letter
Apr 14, 2011	Supplement 16Labeling	Approved	Letter Label Letter Label
Sep 24, 2010	Supplement 18Labeling	Approved	Letter Label
Sep 24, 2010	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 13Labeling	Approved	Letter Label
Feb 26, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 28, 2009	Supplement 11Labeling	Approved	Letter Label
Oct 20, 2008	Supplement 9Labeling · Standard review	Approved	Letter
May 1, 2008	Supplement 7Manufacturing · Standard review	Approved	Letter
Feb 26, 2008	Supplement 4Efficacy (new indication or use)	Approved	Letter Label
Feb 26, 2008	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Jan 2, 2008	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 2, 2008	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 2, 2008	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 11, 2007	Supplement 1Manufacturing	Approved	None posted
Mar 30, 2007	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 22044
Drugs@FDA: Overview at FDA
Company: MSD

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters