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| FDA approval activities
for this prescription 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, , Tentatively Approved 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 |
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