Avandamet

NDA 21410, held by Sb Pharmco. Metformin Hydrochloride; Rosiglitazone Maleate.

As of Nov 15, 2026, NDA 21410 (Avandamet), held by Sb Pharmco, was first approved by FDA on Oct 10, 2002, with 23 approved supplements and 0 published complete response letters.

First approved: Oct 10, 2002
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


Jan 31, 2007	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 19, 2006	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Oct 10, 2002	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

5 strengths and forms


Avandamet500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandamet500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandamet500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandamet1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandamet1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride; Rosiglitazone Maleate	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Apr 5, 2017	Supplement 40Labeling	Approved	Letter Label Medication Guide
Dec 16, 2015	Supplement 39REMS	Approved	Letter
May 7, 2014	Supplement 38REMS	Approved	Label Letter
May 7, 2014	Supplement 37Labeling	Approved	Label Letter
May 7, 2014	Supplement 36REMS	Approved	Label Letter
Sep 16, 2013	Supplement 34REMS	Approved	Letter
Jun 11, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 25, 2013	Supplement 32REMS	Approved	Letter
May 30, 2012	Supplement 30REMS	Approved	Label Letter
Nov 13, 2011	Supplement 29REMS	Approved	Letter Label
May 18, 2011	Supplement 27REMS	Approved	Letter Label
Feb 3, 2011	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 2, 2008	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 20, 2007	Supplement 22Labeling · Standard review	Approved	Label Letter
Aug 21, 2007	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 23, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 31, 2007	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 19, 2006	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Apr 19, 2006	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 4, 2005	Supplement 9Labeling · Standard review	Approved	Review Letter Label
May 19, 2004	Supplement 6Labeling · Standard review	Approved	Label Letter
May 19, 2004	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 25, 2003	Supplement 1Manufacturing · Standard review	Approved	Letter Label
Oct 10, 2002	Original applicationNew combination · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21410
Drugs@FDA: Overview at FDA
Company: SB Pharmco

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