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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 | Avandamet (rosiglitazone maleate and metformin HCl), Tablets, SB Pharmco Puerto Rico, Inc, Labeling Revision | Avandaryl (rosiglitazone maleate and glimepiride), Tablets, SB Pharmco Puerto Rico, Inc, Labeling Revision | Rosiglitazone Maleate, Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval | Rosiglitazone Maleate Tablets, Sandoz Inc., Tentative Approval | Rosiglitazone Maleate and Glimepiride Tablets, Teva Pharmaceuticals, Tentative Approval | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco Puerto Rico, Inc., Labeling Revision | Rosiglitazone Maleate Tablets, Hikma Pharmaceuticals, Tentative Approval | Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Labeling Revision | Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets, SB Pharmco, Labeling Revision
  
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