Betterchem
Health     Industry Portals     News     For Consumers     21CFR     Search     Site Map

 
GLYBURIDE

 
 
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

Safety Information
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…

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 | Glucovance, glyburide; metformin hydrochloride, Tablet; Oral, Bristol Myers Squibb, Manufacturing Change or Addition

^ 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone

© 2016 Betterchem.com