Amaryl

NDA 20496, held by Sanofi Aventis US. Glimepiride.

As of Nov 13, 2026, NDA 20496 (Amaryl), held by Sanofi Aventis US, was first approved by FDA on Nov 30, 1995, with 23 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1995
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Nov 28, 2005	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Sep 27, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Feb 24, 1999	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Review
Nov 30, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms


Amaryl1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride	DiscontinuedReference drug
Amaryl2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride	DiscontinuedReference drug
Amaryl4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Dec 21, 2018	Supplement 29Labeling · Standard review	Approved	Letter Label
Dec 19, 2016	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 15, 2013	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 1, 2013	Supplement 26Labeling · Standard review	Approved	Label Letter
Apr 19, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 14, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 3, 2012	Supplement 22Labeling · Standard review	Approved	Letter Label
Jun 4, 2009	Supplement 21Labeling · Standard review	Approved	Letter Label
Feb 3, 2009	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 3, 2009	Supplement 18Labeling · Standard review	Approved	Letter Label
Nov 28, 2005	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Sep 19, 2005	Supplement 16Labeling · Standard review	Approved	Letter Label
Aug 16, 2004	Supplement 13Labeling · Standard review	Approved	Letter
Apr 15, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Jul 21, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 5, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 27, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Aug 29, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 6, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 24, 1999	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Review
Sep 16, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 16, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 28, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 30, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20496
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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