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U.S. Department of Health and Human Services

Drugs

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Approvals - October 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
175-957OCTREOTIDE ACETATE INJECTION 0.05 MG (BASE)/ML, 0.1 MG(BASE)/ML, AND 0.5 MG (BASE)/ML  SICOR PHARMACEUTICALS, INC.10/3/2005 
276-418AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)  MYLAN PHARMACEUTICALS, INC.10/3/2005 
377-209CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 10 MG  AMIDE PHARMACEUTICAL, INC.10/4/2005 
476-802GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  TEVA PHARMACEUTICALS USA10/6/2005 
576-875GLIMEPIRIDE TABLETS 1 MG, 2 MG, 4 MG, AND 8 MG  RANBAXY LABORATORIES, INC.10/6/2005 
677-091GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  DR. REDDY'S LABORATORIES LIMITED10/6/2005 
777-274GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  COREPHARMA LLC10/6/2005 
877-295GLIMEPIRIDE TABLETS 1 MG, 2 MG, AND 4 MG  INVAGEN PHARMACEUTICALS, INC.10/6/2005 
977-366GLIMEPIRIDE TABLETS 3 MG AND 6 MG  RANBAXY LABORATORIES LIMITED10/6/2005 
1076-606GABAPENTIN CAPSULES 100 MG 300 MG 400 MG  RANBAXY LABORATORIES LIMITED10/7/2005 
1176-817SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 400 MG/80 MG AND 800 MG/160 MG  VISTA PHARMACEUTICALS, INC.10/7/2005 
1277-201KETOROLAC TROMETHAMINE INJECTION USP, 30 MG/ML; PACKAGED IN 150 MG/5 ML MULTIPLE-DOSE VIALS  APOTEX INC.10/14/2005 
1377-220PILOCARPINE HYDROCHLORIDE TABLETS 5 MG  LANNETT HOLDINGS, INC.10/14/2005 
1465-144CLARITHROMYCIN TABLETS USP, 250 MG  SANDOZ INC.10/18/2005 
1576-723HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 8 MG  AMIDE PHARMACEUTICAL, INC.10/18/2005 
1676-549RAMIPRIL CAPSULES 1.25 MG, 2.5 MG, 5 MG, AND 10 MG  COBALT PHARMACEUTICALS, INC.10/24/2005 
1776-686DANTROLENE SODIUM CAPSULES 25 MG, 50 MG, AND 100 MG  AMIDE PHARMACEUTICAL, INC.10/24/2005 
1877-507GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS 2.5 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  COREPHARMA LLC10/27/2005 
1965-187NEOMYCIN & POLYMYXIN B SULFATES & GRAMICIDIN OPHTHALMIC SOL 1.75 MG(BASE)/10,0000 UNITS/0.025 MG PER ML  PHARMAFORCE, INC.10/28/2005 
2076-763CLOTRIMAZOLE LOZENGES USP, 10 MG  PADDOCK LABORATORIES, INC.10/28/2005 
2177-224RIBAVIRIN CAPSULES 200 MG  ZYDUS PHARMACEUTICALS USA INC.10/28/2005 
2277-270GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLETS 2.5 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  TEVA PHARMACEUTICALS USA10/28/2005 
2365-216NEOMYCIN & POLYMYXIN B SULFATES & HYDROCORTISONE OTIC SOL, U 3.5 MG (BASE)/10,000U/10 MG PER ML  PHARMAFORCE, INC.10/31/2005 
2476-635FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG  RANBAXY LABORATORIES LIMITED10/31/2005 
2577-232CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  PLIVA HRVATSKA D.O.O.10/31/2005