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FDA Approval Activities for this Drug…
Glucovance (glyburide and metformin) Tablet, Bristol-Myers Squibb NDA 21-178 7/31/00 8/4/00 8/4/00 Glucovance Indications: 1. As initial therapy, as an adunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. 2. As second-line therapy when diet, exercise and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. Glyburide Tablets USP (Micronized), 1.5, 2.5 & 5 mg, Corepharma ANDA 76-257 6/27/02 Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Amide Pharmaceutical, ANDA 75-947 11/14/02 Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Hikma ANDA 75-890 7/31/03 Glyburide Tablets USP (Micronized), 1.5, 3 & 6 mg, Al-Hikma ANDA 75-890 2/8/02 4/10/03 Glyburide Tablets USP (Micronized), 1.5 mg and 3 mg Invamed ANDA 75-174 6/22/98 6/26/98 Glyburide Tablets (Micronized), 1.5 and 3 mg Mylan Pharmacueticals ANDA 74-792 6/26/98 7/6/98 Glyburide Tablets USP (Micronized), 1.5 mg, 3 mg, 4.5 mg, and 6 mg, Novopharm Limited ANDA 74-686 GLYBURIDE Tablet; 1.5MG GLYBURIDE Amide 075947 GLYBURIDE Tablet; 3MG GLYBURIDE Amide 075947 GLYBURIDE Tablet; 6MG GLYBURIDE Amide 017532 BX GLYBURIDE Tablet; 1.25MG DIABETA AVENTIS 020055 GLYBURIDE Tablet; 1.5MG GLYBURIDE (MICRONIZED) AVENTIS 017532 BX GLYBURIDE Tablet; 2.5MG DIABETA AVENTIS 020055 GLYBURIDE Tablet; 3MG GLYBURIDE (MICRONIZED) AVENTIS 017532 BX GLYBURIDE Tablet; 5MG DIABETA AVENTIS 020055 GLYBURIDE Tablet; 6MG GLYBURIDE (MICRONIZED) AVENTIS 074591 GLYBURIDE Tablet; 1.5MG GLYBURIDE (MICRONIZED) CLONMEL 074591 GLYBURIDE Tablet; 3MG GLYBURIDE (MICRONIZED) CLONMEL 074591 GLYBURIDE Tablet; 4.5MG GLYBURIDE (MICRONIZED) CLONMEL 074591 GLYBURIDE Tablet; 6MG GLYBURIDE (MICRONIZED) CLONMEL 076257 GLYBURIDE Tablet; 1.25MG GLYBURIDE Corepharma 076257 GLYBURIDE Tablet; 2.5MG GLYBURIDE Corepharma 076257 GLYBURIDE Tablet; 5MG GLYBURIDE Corepharma 075174 GLYBURIDE Tablet; 1.5MG GLYBURIDE (MICRONIZED) Geneva TECH 075174 GLYBURIDE Tablet; 3MG GLYBURIDE (MICRONIZED) Geneva TECH 075890 GLYBURIDE Tablet; 1.5MG GLYBURIDE (MICRONIZED) Hikma 075890 GLYBURIDE Tablet; 3MG GLYBURIDE (MICRONIZED) Hikma 075890 GLYBURIDE Tablet; 6MG GLYBURIDE (MICRONIZED) Hikma 074792 GLYBURIDE Tablet; 1.5MG GLYBURIDE (MICRONIZED) Mylan | 074792 GLYBURIDE Tablet; 3MG GLYBURIDE (MICRONIZED) Mylan | 074792 GLYBURIDE Tablet; 6MG GLYBURIDE (MICRONIZED) Mylan | 017498 GLYBURIDE Tablet; 1.25MG MICRONASE PHARMACIA AND UPJOHN | 020051 GLYBURIDE Tablet; 1.5MG GLYNASE PHARMACIA AND UPJOHN | 017498 GLYBURIDE Tablet; 2.5MG MICRONASE PHARMACIA AND UPJOHN | 020051 GLYBURIDE Tablet; 3MG GLYNASE PHARMACIA AND UPJOHN | 017498 GLYBURIDE Tablet; 5MG MICRONASE PHARMACIA AND UPJOHN | 020051 GLYBURIDE Tablet; 6MG GLYNASE PHARMACIA AND UPJOHN | 074388 GLYBURIDE Tablet; 1.25MG GLYBURIDE Teva | 074686 GLYBURIDE Tablet; 1.5MG GLYBURIDE (MICRONIZED) Teva | 074388 GLYBURIDE Tablet; 2.5MG GLYBURIDE Teva | 074686 GLYBURIDE Tablet; 3MG GLYBURIDE (MICRONIZED) Teva | 074686 GLYBURIDE Tablet; 4.5MG GLYBURIDE (MICRONIZED) Teva | 074388 GLYBURIDE Tablet; 5MG GLYBURIDE Teva | 074686 GLYBURIDE Tablet; 6MG GLYBURIDE (MICRONIZED) Teva | 021178 GLYBURIDE; METFORMIN HYDROCHLORIDE Tablet; 1.25MG;250MG GLUCOVANCE BRISTOL MYERS SQUIBB | 021178 GLYBURIDE; METFORMIN HYDROCHLORIDE Tablet; 2.5MG;500MG GLUCOVANCE BRISTOL MYERS SQUIBB | 021178 GLYBURIDE; METFORMIN HYDROCHLORIDE Tablet; 5MG;500MG GLUCOVANCE BRISTOL MYERS SQUIBB Glyburide & Metformin Hydrochloride Tablets, Ivax Pharmaceuticals Glucovance (Glyburide and Metformin HCl) Tablets, Bristol-Myers Squibb Glyburide & Metformin Hydrochloride Tablets, Corepharma | Glyburide and Metformin Hydrochloride Tablets, Teva, Approval | Glyburide and Metformin Hydrochloride Tablets, Purepac Pharma, Approval | Glyburide Tablets, Aurobindo Pharma, Approval | Glyburide and Metformin Hydrochloride Tablets, Aurobindo Pharma, Approval | Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Glynase (glyburide) Tablets, Pharmacia & Upjohn Co., Labeling Revision | Micronase (glyburide) Tablets, Pharmacia & Upjohn Co., Package Change | Glynase (glyburide) Tablets, Pharmacia & Upjohn Co., Labeling Revision | Diabeta (glyburide) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision | Glyburide and Metformin Hydrochloride Tablets, Indicus Pharma, LLC, Approval | Diabeta (glyburide) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision | Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Company, Labeling Revision | Micronase (glyburide) Tablets, Pfizer, Inc., Labeling Revision | Glynase (glyburide) Tablets, Pfizer Inc., Labeling Revision | Glyburide Tablets, Indicus Pharma LLC, Approval
  
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