Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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,   For the latest approval information, locate this drug using this index.