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FDA approval activities for this prescription 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) GlucophageŽ (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, Tentatively Approved TEVA ANDA 76-269 3/25/03 Metformin Hydrochloride Extended-Release Tablets, 500 mg, Tentatively Approved 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, Tentatively Approved 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 HCI) 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

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