Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Avandamet (rosiglitazone maleate/metformin HCl) Tablets, SB Pharmco Puerto Rico, NDA 21-410/S1 8/25/03 8/28/03 8/28/03 Avandamet (rosiglitazone maleate/metformin HCl) Tablets, 1 mg/500 mg, 2 mg/500 mg, and 4 mg/500 mg, GlaxoSmithKline NDA 21-410 10/10/02 10/21/02 10/17/02 4/30/03 Avandia (rosiglitazone maleate) Tablets, 2, 4, and 8 mg, GlaxoSmithKline NDA 21-071/S008 12/3/02 12/9/02 Avandia (rosiglitazone maleate) Tablets, 2, 4, and 8 mg, SmithKline Beecham . NDA 21-071/S004 2/27/03 3/10/03 3/11/03 Avandia (rosiglitazone maleate) Tablets, 2, 4, and 8 mg, SmithKline Beecham . NDA 21-071/S001 4/4/00 4/4/00 11/20/01 11/20/01 Avandia Indications: Use Avandia in combination with a sulfonylurea in patients with type 2 diabetes mellitus when diet and exercise with either single agent does not achieve adequate glycemic control. Avandia (rosiglitazone) Tablets, 2, 4, and 8 mg, SmithKline Beecham . NDA 21-071 5/25/99 6/1/99 6/1/99 11/20/01 Avandia Indications: Used as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes mellitus as monotherapy or in combination with metformin. METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Tablet; 1GM;EQ 2MG BASE AVANDAMET SB PHARMCO 021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Tablet; 1GM;EQ 4MG BASE AVANDAMET SB PHARMCO 021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Tablet; 500MG;EQ 1MG BASE AVANDAMET SB PHARMCO 021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Tablet; 500MG;EQ 2MG BASE AVANDAMET SB PHARMCO 021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Tablet; 500MG;EQ 4MG BASE AVANDAMET SB PHARMCO 021071 ROSIGLITAZONE MALEATE Tablet; 2MG BASE AVANDIA SB PHARMCO | 021071 ROSIGLITAZONE MALEATE Tablet; 4MG BASE AVANDIA SB PHARMCO | 021071 ROSIGLITAZONE MALEATE Tablet; 8MG BASE AVANDIA SB PHARMCO | Avandamet, GlaxoSmithKline | Avandia, GlaxoSmithKline | Avandia Tablet, GlaxoSmithKline, Labeling Revision | Avandamet Tablet, GlaxoSmithKline, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, New or Modified Indication | Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Patient Population Altered | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, GlaxoSmithKline, Approval | Rosiglitazone Maleate Tablets, Dr. Reddy’s Labs, Tentative Approval | Avandamet (rosiglitazone maleate/metformin Hcl), GlaxoSmithKline, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Efficacy Supp w/Clinical Data | Avandamet (rosiglitazone maleate and metformin HCl) tablets, GlaxoSmithKline, New or Modified Indication | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, GlaxoSmithKline, Labeling Revision | Avandia (rosiglitazone maleate) tablets, GlaxoSmithKline, Labeling Revision | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, New or Modified Indication | Avandamet (rosiglitazone maleate/metformin HCl), SB Pharmco, New or Modified Indication | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Manufacturing Change or Addition | Rosiglitazone Maleate and Metformin Hydrochloride Tablets, Teva Pharma, Tentative Approval | Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision | Avandamet (rosiglitazone maleate and metformin HCl) Tablets, SB Pharmco, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, SB Pharmaco, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision | Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets, SB Pharmco, Labeling Revision | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision | Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Labeling Revision | Rosiglitazone Maleate Tablets, Roxane Labs, Tentative Approval | Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com