Avandaryl

NDA 21700, held by Sb Pharmco. Glimepiride; Rosiglitazone Maleate.

As of Nov 14, 2026, NDA 21700 (Avandaryl), held by Sb Pharmco, was first approved by FDA on Nov 23, 2005, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 23, 2005
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Oct 24, 2006	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Nov 23, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

5 strengths and forms


Avandaryl1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandaryl2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandaryl4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandaryl2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride; Rosiglitazone Maleate	DiscontinuedReference drug
Avandaryl4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Glimepiride; Rosiglitazone Maleate	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Dec 16, 2015	Supplement 22REMS	Approved	Letter
Mar 16, 2015	Supplement 21Labeling · Standard review	Approved	Medication Guide Label Letter
May 7, 2014	Supplement 20REMS	Approved	Label Letter
May 7, 2014	Supplement 19Labeling	Approved	Label Letter
May 7, 2014	Supplement 18REMS	Approved	Label Letter
Sep 16, 2013	Supplement 16REMS	Approved	Letter
Jan 25, 2013	Supplement 15REMS	Approved	Letter
May 30, 2012	Supplement 13REMS	Approved	Label Letter
Nov 13, 2011	Supplement 12REMS	Approved	Letter Label
May 18, 2011	Supplement 11REMS	Approved	Letter Label
Feb 3, 2011	Supplement 10Labeling · Standard review	Approved	Label Letter
Nov 29, 2009	Supplement 9Labeling · Standard review	Approved	Label
Dec 2, 2008	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 20, 2007	Supplement 6Labeling · Standard review	Approved	Letter
Aug 21, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 30, 2007	Supplement 5Manufacturing	Approved	Letter
Oct 24, 2006	Supplement 3Efficacy (new indication or use)	Approved	Letter Label
Jun 15, 2006	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 15, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 23, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21700
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