Januvia

For type 2 diabetes mellitus. NDA 21995, held by Msd. Sitagliptin Phosphate.

As of Nov 13, 2026, NDA 21995 (Januvia), held by Msd, was first approved by FDA on Oct 16, 2006, with 35 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2006
Review: Standard
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Dec 4, 2020	Supplement 47Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 12, 2019	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 24, 2010	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 26, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 12, 2007	Supplement 3Efficacy (new indication or use)	Approved	Letter
Oct 12, 2007	Supplement 2Efficacy (new indication or use)	Approved	Letter
Oct 16, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


JanuviaEQ 25MG BASE · tablet;oral	Sitagliptin Phosphate	RxReference drug
JanuviaEQ 50MG BASE · tablet;oral	Sitagliptin Phosphate	RxReference drug
JanuviaEQ 100MG BASE · tablet;oral	Sitagliptin Phosphate	RxReference drug

All 36 submissions, including labeling and manufacturing supplements


Dec 28, 2023	Supplement 53Manufacturing	Approved	Label
Jun 21, 2022	Supplement 50Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 4, 2020	Supplement 47Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 12, 2019	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 1, 2019	Supplement 46Labeling	Approved	Label Letter
Feb 9, 2018	Supplement 42Labeling · Standard review	Approved	Letter Label
Aug 10, 2017	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 18, 2017	Supplement 38Labeling · Standard review	Approved	Letter Label
Jan 11, 2016	Supplement 35Manufacturing · Standard review	Approved	None posted
Aug 28, 2015	Supplement 34Labeling	Approved	Label Letter
Apr 27, 2015	Supplement 33Labeling · Standard review	Approved	Label Letter
Mar 10, 2015	Supplement 32Manufacturing · Standard review	Approved	Letter Label
Oct 17, 2013	Supplement 28Manufacturing · Standard review	Approved	Label
Aug 19, 2013	Supplement 29Labeling · Standard review	Approved	Letter Label
Feb 11, 2013	Supplement 27Labeling · Standard review	Approved	Letter Label
Dec 7, 2012	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 18, 2012	Supplement 25Labeling	Approved	Label Letter
Mar 24, 2012	Supplement 23Labeling	Approved	Letter Label
Feb 27, 2012	Supplement 19Manufacturing	Approved	Label
Jun 10, 2011	Supplement 16Labeling	Approved	Letter
Apr 14, 2011	Supplement 17Labeling	Approved	Letter Label
Sep 24, 2010	Supplement 18Labeling	Approved	Letter Label
Sep 24, 2010	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 26, 2010	Supplement 14Labeling	Approved	Review Letter Label
Feb 26, 2010	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 26, 2010	Supplement 11Efficacy (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 13Labeling	Approved	Review Letter Label
Oct 20, 2008	Supplement 9Labeling · Standard review	Approved	Letter
Jul 22, 2008	Supplement 7Labeling · Standard review	Approved	Letter Label
Oct 12, 2007	Supplement 6Labeling · Standard review	Approved	Letter
Oct 12, 2007	Supplement 4Labeling · Standard review	Approved	Letter
Oct 12, 2007	Supplement 3Efficacy (new indication or use)	Approved	Letter
Oct 12, 2007	Supplement 2Efficacy (new indication or use)	Approved	Letter
Apr 10, 2007	Supplement 1Manufacturing	Approved	None posted
Oct 16, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21995
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