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FDA Approval Activities for this Drug…
Glucophage (metformin) Tablets(500 mg, 625 mg, 750 mg, 850 mg, 1000 mg), Bristol-Myers Squibb NDA 20-357/S-010 10/22/98 10/26/98 7/2/99 Glucophage Indication:This sNDA provided for the use of metformin and insulin in type 2 diabetes. Glucophage (metformin) Tablets, (500 mg, 625 mg, 750 mg, 850 mg, 1000 mg), Bristol-Myers Squibb NDA 20-357/S-017 9/22/99 7/6/00 Glucophage (Metformin Hydrochloride) Tablets, Bristol-Myers Squibb NDA 20-357/S-019 12/15/00 2/20/01 8/17/01 Glucophage Indication:Treatment of type 2 diabetes in pediatric patients (ages 10-16 years) Glucophage(r) (metformin hydrochloride) Tablets, (500 mg, 850, and 1000 mg), Bristol-Myers Squibb NDA 20-357/S-020 4/23/01 4/8/03 Glucophage XR (metformin HC1 extended-release) Tablets, (500 mg, 850 mg, 1000 mg), Bristol-Myers Squibb NDA 21-202 10/13/00 10/20/00 10/20/00 2/3/03 Glucophage XR (metformin hydrochloride extended-release) Tablets, Bristol-Myers Squibb NDA 21-202/S8 4/11/03 4/18/03 4/18/03 Glucophage XR (metformin hydrochloride extended-release) Tablets, 500 mg. Bristol-Myers Squibb NDA 21-202/S-001 4/19/01 5/1/01 Glucophage (metformin hydrochloride)Tablets,Glucophage and Glucophage XR (metformin hydrochloride extended-release) Tablets, Bristol-Myers Squibb NDA 21-202/S-003 & 20-357/S-024 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. Metaglip (glipizide/metformin HCl) Tablets, 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg, Bristol-Myers Squibb, NDA 21-460 Metformin Hydrochloride Extended-Release Tablets, 500 mg, Teva ANDA 76-269 3/25/03 Metformin Hydrochloride Extended-Release Tablets, 500 mg, Geneva Technology Corp. ANDA 76-223 5/6/02 Metformin Hydrochloride Tablets, 500, 850, & 1000 mg, Teva ANDA 76-328 12/16/02 Metformin Hydrochloride Extended-release Tablets, 500 mg, Andrx ANDA 76-172 4/18/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1 g, Purepac Pharmaceutical Co. ANDA 76-033 1/24/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1 g, Geneva ANDA 75-985 1/25/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1 g, TorPharm, ANDA 75-984 4/23/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1 g, Watson, ANDA 75-979 1/24/02 Metformin Hydrochloride Tablets, 1000 mg, Teva ANDA 75-978/S1, S4 11/5/02 Metformin Hydrochloride Tablets, 500 mg & 850 mg, Teva ANDA 75-978 1/25/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1 g, Mylan ANDA 75-976 1/24/02 Metformin Hydrochloride Tablets, 750 mg, 850 mg, and 1 g, Zenith Goldline ANDA 75-975 1/24/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1 g, Genpharm ANDA 75-973 1/25/02 Metformin Hydrochloride Tablets, 500, 625, 750, 850mg, and 1 g, Goldline , ANDA 75-972 1/24/02 Metformin Hydrochloride Tablets, 500, 850 and 1 g, Barr ANDA 75-971 1/25/02 Metformin Hydrochloride Tablets, 500, 850 and 1 g, Eon Labs ANDA 75-965 1/25/02 Metformin Hydrochloride Tablets, 500, 850 and 1 g, Andrx ANDA 75-961 1/25/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1000 mg, Alphapharm Pty Ltd. ANDA 75-969 1/29/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1000 mg, Caraco Pharmaceutical Laboaratories, Ltd. ANDA 75-967 1/29/02 Metformin Hydrochloride Tablets, 500 mg, 850 mg, and 1000 mg, Issued Approvable Letter Caraco Pharmaceutical Laboaratories, Ltd. ANDA 75-967 12/26/01 Metformin Hydrochloride Tablets, 500 mg, 625 mg, 750 mg, 850 mg, and 1000 mg, Issued Approvable Letter Goldline , ANDA 75-972 Metformin Hydrochloride Extended-Release Tablets, 500 mg, Ivax ANDA 76-545 Riomet (Metformin HCl) Solution, Ranbaxy NDA 21-591 Metformin Hydrochloride Extended-Release Tablets, Ivax GLIPIZIDE; METFORMIN HYDROCHLORIDE Tablet; 2.5MG;250MG METAGLIP BRISTOL MYERS SQUIBB 021460 GLIPIZIDE; METFORMIN HYDROCHLORIDE Tablet; 2.5MG;500MG METAGLIP BRISTOL MYERS SQUIBB 021460 GLIPIZIDE; METFORMIN HYDROCHLORIDE Tablet; 5MG;500MG METAGLIP BRISTOL MYERS SQUIBB 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 021591 METFORMIN HYDROCHLORIDE Solution; 500MG/5ML RIOMET Ranbaxy 021202 METFORMIN HYDROCHLORIDE Tablet, Extended Release; 500MG GLUCOPHAGE XR BRISTOL MYERS SQUIBB 021202 METFORMIN HYDROCHLORIDE Tablet, Extended Release; 750MG GLUCOPHAGE XR BRISTOL MYERS SQUIBB 075969 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Alphapharm 075969 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Alphapharm 075969 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Alphapharm 075961 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Andrx 075961 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Andrx 075961 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Andrx 075971 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Barr 075971 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Barr 075971 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Barr 020357 METFORMIN HYDROCHLORIDE Tablet; 1GM GLUCOPHAGE BRISTOL MYERS SQUIBB 020357 METFORMIN HYDROCHLORIDE Tablet; 500MG GLUCOPHAGE BRISTOL MYERS SQUIBB 020357 METFORMIN HYDROCHLORIDE Tablet; 850MG GLUCOPHAGE BRISTOL MYERS SQUIBB 075967 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Caraco 075967 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Caraco 075967 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Caraco 075965 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Eon 075965 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Eon 075965 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Eon 075985 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Geneva 075985 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Geneva 075985 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Geneva 075973 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Genpharm 075973 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Genpharm 075973 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Genpharm 075972 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL GOLDLINE 075972 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL GOLDLINE 075972 METFORMIN HYDROCHLORIDE Tablet; 625MG METFORMIN HCL GOLDLINE 075972 METFORMIN HYDROCHLORIDE Tablet; 750MG METFORMIN HCL GOLDLINE 075972 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL GOLDLINE 076038 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Mutual 076038 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Mutual 076038 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Mutual 075976 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Mylan 075976 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Mylan 075976 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Mylan 076033 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Purepac 076033 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Purepac 076033 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Purepac 076328 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Teva 075978 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Teva 075978 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Teva 076328 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Teva 076328 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Teva 075978 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Teva 075984 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Torpharm 075984 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Torpharm 075984 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Torpharm 075979 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL Watson 075979 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL Watson 075979 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL Watson 075975 METFORMIN HYDROCHLORIDE Tablet; 1GM METFORMIN HCL ZENITH GOLDLINE 075975 METFORMIN HYDROCHLORIDE Tablet; 500MG METFORMIN HCL ZENITH GOLDLINE 075975 METFORMIN HYDROCHLORIDE Tablet; 625MG METFORMIN HCL ZENITH GOLDLINE 075975 METFORMIN HYDROCHLORIDE Tablet; 750MG METFORMIN HCL ZENITH GOLDLINE 075975 METFORMIN HYDROCHLORIDE Tablet; 850MG METFORMIN HCL ZENITH GOLDLINE 021410 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 Glyburide & Metformin Hydrochloride Tablets, Ivax Pharmaceuticals Glucovance (Glyburide and Metformin HCl) Tablets, Bristol-Myers Squibb Glucophage and Glucophage XR (metformin hydrochloride) Tablets & Extended-Release Tablets, Bristol-Myers Squibb Fortamet (Metformin HCl ) Extended-Release Tablets, Andrx Labs Riomet (metformin HCl oral solution), Ranbaxy Metformin Hydrochloride Extended-release Tablets, Andrx Pharmaceuticals Metformin Hydrochloride Extended-release Tablets, Ranbaxy Laboratories Metformin Hydrochloride Extended-release Tablets, Teva Pharmaceuticals Metformin Hydrochloride Extended-release Tablets, Apotex Inc., Glyburide & Metformin Hydrochloride Tablets, Corepharma, Metformin Hydrochloride Extended-Release Tablets, Impax Laboratories, Approval | Metformin Hydrochloride Extended-Release Tablets, Cobalt Pharma, Tentative Approval | Metformin Hydrochloride Extended-Release Tablets, Andrx, Tentative Approval | Metformin Hydrochloride Extended-release Tablets, Purepac Pharma, Approval | Metformin Hydrochloride Extended-Release Tablets, Purepac Pharma, Tentative Approval | Metformin Hydrochloride Extended-Release Tablets, Eon Labs, Tentative Approval | Metformin Hydrochloride Extended-Release Tablets, Barr Labs, Approval | Metformin Hydrochloride Extended-Release Tablets, Teva, Tentative Approval | Metformin Hydrochloride Tablets, Aurobindo Pharma, Approval | Glyburide and Metformin Hydrochloride Tablets, Teva, Approval | Metformin Hydrochloride Extended-Release Tablets, Andrx Pharma, Approval | Metformin Hydrochloride Extended-Release Tablets, Teva Pharma, Approval | Metformin Hydrochloride Tablets, Zydus Pharma, Approval | Metformin Hydrochloride Extended-Release Tablets, Zydus Pharma, Approval | Metformin Extended-Release Tablets, Zydus Pharma, Approval | Metformin Extended-Release Tablets, Zydus Pharma, Approval | Glumetza (metformin hydrochloride) extended-release tablets, Biovail Labs, Approval | Metformin Hydrochloride Extended-release Capsules, Ranbaxy Inc., Approval | Actoplus Met (pioglitazone and metformin HCl) Tablets, Takeda Global, Approval | Metformin Hydrochloride Extended-Release Tablets, Mylan Pharma, Approval | Metformin Hydrochloride Extended Release Tablets, Mylan Pharma, Approval | Metformin Hydrochloride Extended Release Tablets, Impax Labs, Approval | Riomet (metformin HCl oral solution), Ranbaxy, Labeling Revision | Glipizide and Metformin Hydrochloride Tablets, CorePharma, Approval | Glipizide and Metformin Hydrochloride Tablets, Teva Pharma, Approval | Metformin Hydrochloride Extended-Release Tablets, Barr Labs, Approval | Metformin Hydrochloride Extended-Release Tablets, Mutual Pharma, Approval | Avandamet (rosiglitazone maleate/metformin Hcl), GlaxoSmithKline, Labeling Revision | Avandamet (rosiglitazone maleate and metformin HCl) tablets, GlaxoSmithKline, New or Modified Indication | Metformin Hydrochloride Tablets, Interpharm, Approval | Metformin Hydrochloride Extended Release Tablets, Synovics Labs, Approval | Metformin Hydrochloride Tablets, Amneal Pharma, Approval | Metformin Hydrochloride Tablets, Dr. Reddy’s Labs, Approval | ActoPlus Met (pioglitazone HCl plus metformin HCl) Global, Labeling Revision | Glucophage (metformin HCl) tablets, Bristol-Myers Squibb, Labeling Revision | Glucophage XR (metformin HCl extended-release) tablets, Bristol-Myers Squibb, Labeling Revision | Glumetza (metformin HCl) Extended-Release Tablets, DepoMed, Labeling Revision | Actoplus Met (pioglitazone HCl + metformin HCl) fixed-dose combination tablets, Takeda Global, Labeling Revision | Metformin Hydrochloride Tablets, Torrent Pharma, Approval | Avandamet (rosiglitazone maleate/metformin HCl), SB Pharmco, New or Modified Indication | Janumet (sitagliptin/metformin hydrochloride) Tablets, Merck & Co., Approval | Glipizide and Metformin Hydrochloride Tablets, Approval | Metformin Hydrochloride Extended Release Tablets, Ranbaxy Inc., Supplier Addition | Fortamet (Metformin HCl) Extended-Release Tablets, Andrx Labs, Labeling Revision | Rosiglitazone Maleate and Metformin Hydrochloride Tablets, Teva Pharma, Tentative Approval | Avandamet (rosiglitazone maleate and metformin HCl) Tablets, SB Pharmco, Labeling Revision | Metformin Hydrochloride Tablets, Ohm Labs, Approval | Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets, SB Pharmco, Labeling Revision | Actoplus Met (pioglitazone HCl and metformin HCl) fixed-dose combination Tablets, Takeda Global, Labeling Revision | Glyburide and Metformin Hydrochloride Tablets, Aurobindo Pharma, Approval | Janumet (sitagliptin/metformin hydrochloride fixed-dose combination) Tablets, Merck & Co., Labeling Revision | Metformin Hydrochloride Extended-Release Tablets, Interpharm, Approval | Glipizide and Metformin Hydrochloride Tablets, Caraco Pharma, Approval | Metformin Hydrochloride Extended-Release Tablets, NeuroSci Inc., Approval | Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck & Co., Inc., Manufacturing Change or Addition | Metformin Hydrochloride Tablets, Glenmark Pharmaceuticals Inc., USA, Approval | PrandiMet (repaglinide and metformin hydrochloride) Tablets, Novo Nordisk, Inc., Approval | Fortamet (metformin hydrochloride) Extended-Release Tablets, Andrx Pharmaceuticals, LLC, Labeling Revision | Metaglip (glipizide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Glucophage (metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Glucophage XR (metformin hydrochloride) Extended-Release Tablets, Bristol-Myers Squibb Co., Labeling Revision | Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
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