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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-761OXANDROLONE TABLETS USP, 2.5 MGUPSHER-SMITH LABORATORIES, INC.12/1/2006 
276-897OXANDROLONE TABLETS USP, 2.5 MG 10 MGSANDOZ INC.12/1/2006 
377-395PAROXETINE HYDROCHLORIDE ORAL SUSPENSION, 10 MG/5 MLAPOTEX INC.12/4/2006 
440-654PROMETHAZINE HCL AND PHENYLEPHRINE HCL ORAL SOLUTION, 6.25 MG/5 MG PER 5 MLVINTAGE PHARMACEUTICALS, LLC12/7/2006 
540-660PROMETHAZINE, PHENYLEPHRINE, CODEINE ORAL SOLUTION, 6.25 MG/5 MG/10 MG PER 5 MLVINTAGE PHARMACEUTICALS, LLC12/7/2006 
677-918MELOXICAM TABLETS, 7.5 MG 15 MGCARLSBAD TECHNOLOGY INC.12/7/2006 
740-621EXTENDED PHENYTOIN SODIUM CAPSULES USP, 100 MGSUN PHARMACEUTICAL INDUSTRIES LTD12/11/2006 
840-652TESTOSTERONE CYPIONATE INJECTION USP, 200 MG/MLSYNERX PHARMA, LLC12/11/2006 
977-489TRANDOLAPRIL TABLETS, 1 MG, 2 MG, AND 4 MGTEVA PHARMACEUTICALS USA12/12/2006 
1077-992AMANTADINE HYDROCHLORIDE ORAL SOLUTION USP, 50 MG/5 MLVINTAGE PHARMACEUTICALS12/12/2006 
1140-672TRIAMCINOLONE ACETONIDE LOTION USP, 0.1%VINTAGE PHARMACEUTICALS, LLC12/13/2006 
1265-198CEFPROZIL TABLETS USP, 250 MG AND 500 MGRANBAXY LABORATORIES LIMITED12/13/2006 
1377-396LORAZEPAM TABLETS USP, 0.5 MG, 1 MG, AND 2 MGIVAX PHARMACEUTICALS INC.12/13/2006 
1477-689CIPROFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%NEXUS PHARMACEUTICALS, INC.12/13/2006 
1577-899NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 30 MG AND 60 MGABRIKA PHARMACEUTICALS, INC.12/13/2006 
1665-275IDARUBICIN HYDROCHLORIDE INJECTION, 1 MG/ML; 5 ML, 10 ML, AND 20 ML VIALSBEDFORD LABORATORIES12/14/2006 
1777-284BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG AND 300 MG (ONCE-A-DAY)ANCHEN PHARMACEUTICALS, INC.12/14/2006 
1878-039MELOXICAM TABLETS, 7.5 MG AND 15 MGRANBAXY LABORATORIES LTD.12/14/2006 
1976-511FINASTERIDE TABLETS USP, 5 MGTEVA PHARMACEUTICALS, USA12/15/2006 
2077-415BUPROPION HCL EXTENDED-RELEASE TABLETS USP, 300 MGIMPAX LABORATORIES, INC.12/15/2006 
2177-676CICLOPIROX TOPICAL SUSPENSION USP, 0.77%PERRIGO NEW YORK, INC.12/15/2006 
2276-918FLUCONAZOLE FOR ORAL SUSPENSION, 10 MG/ML AND 40 MG/MLTARO PHARMACEUTICAL INDUSTRIES LTD.12/18/2006 
2377-578FINASTERIDE TABLETS USP, 5 MGMYLAN PHARMACEUTICALS, INC.12/18/2006 
2476-685SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MGCOBALT PHARMACEUTICALS, INC.12/20/2006 
2577-691SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MGAUROBINDO PHARMA LIMITED12/20/2006 
2677-752SIMVASTATIN TABLETS USP, 10 MG, 20 MG, 40 MG, AND 80 MGDR. REDDY'S LABORATORIES LIMITED12/20/2006 
2777-766SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MGSANDOZ INC.12/20/2006 
2877-837SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MGZYDUS PHARMACEUTICALS USA, INC.12/20/2006 
2977-927MELOXICAM TABLETS, 7.5 MG AND 15 MGUNICHEM LABORATORIES LIMITED12/20/2006 
3078-034SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MGPERRIGO R & D COMPANY12/20/2006 
3176-867ALBUTEROL SULFATE & IPRATROPIUM BROMIDE INHALATION SOLUTION, 3 MG (0.083%) AND 0.5 MG (0.017%); 3 ML VIALSSANDOZ INC.12/21/2006 
3277-251FINASTERIDE TABLETS USP, 5 MGGEDEON RICHTER LTD.12/22/2006 
3376-183ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE)DR. REDDY'S LABORATORIES LIMITED12/26/2006 
3476-506ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 4 MG AND 8 MGKALI LABORATORIES, INC.12/26/2006 
3576-559ONDANSETRON HYDROCHLORIDE TABLETS, 16 MG (BASE)DR. REDDY'S LABORATORIES LIMITED12/26/2006 
3676-695ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSMAYNE PHARMA (USA), INC.12/26/2006 
3776-696ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSMAYNE PHARMA (USA), INC.12/26/2006 
3876-780ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSHIKMA FARMACEUTICA (PORTUGAL), S.A.12/26/2006 
3976-781ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSHIKMA FARMACEUTICA (PORTUGAL), S.A.12/26/2006 
4076-960ONDANSETRON ORAL SOLUTION USP, 4 MG/5 MLROXANE LABORATORIES, INC.12/26/2006 
4176-967ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSBEDFORD LABORATORIES12/26/2006 
4276-972ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSABRAXIX PHARMACEUTICAL PRODUCTS12/26/2006 
4376-974ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSABRAXIS PHARMACEUTICAL PRODUCTS12/26/2006 
4477-011ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML, 2ML VIALSBEDFORD LABORATORIES12/26/2006 
4577-172ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSSUN PHARMACEUTICAL INDUSTRIES, LTD.12/26/2006 
4677-173ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSSUN PHARMACEUTICAL INDUSTRIES, LTD.12/26/2006 
4777-343ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSAPOTEX INC.12/26/2006 
4877-365ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSBAXTER HEALTHCARE CORPORATION12/26/2006 
4977-368ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSAPOTEX INC.12/26/2006 
5077-387ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSPHARMAFORCE, INC.12/26/2006 
5177-406ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, 16 MG AND 24 MGKALI LABORATORIES, INC.12/26/2006 
5277-473ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSHOSPIRA INC.12/26/2006 
5377-541ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSBAXTER HEALTHCARE CORPORATION12/26/2006 
5477-544ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSPLIVA HRVATSKA d.o.o.12/26/2006 
5577-548ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML 2 ML VIALSHOSPIRA INC.12/26/2006 
5677-577ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSWOCKHARDT LIMITED12/26/2006 
5777-582ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALSPHARMAFORCE, INC.12/26/2006 
5877-716ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; 2 ML VIALSWOCKHARDT LIMITED12/26/2006 
5977-877ATENOLOL TABLETS USP, 25 MG, 50 MG, AND 100 MGOHM LABORATORIES, INC.12/27/2006 
6077-910BISOPROLOL FUMARATE TABLETS USP, 5 MG AND 10 MGAUROBINDO PHARMA LIMITED12/27/2006 
6178-105ALBUTEROL SULFATE SYRUP, 2 MG (BASE)/5 MLVINTAGE PHARMACEUTICALS, LLC12/27/2006 
6240-624METHSCOPOLAMINE BROMIDE TABLETS USP, 2.5 MG AND 5 MGBOCA PHARMACAL, INC.12/28/2006 
6365-334AMOXICILLIN FOR ORAL SUSPENSION USP, 200 MG/5 ML AND 400 MG/5 MLAUROBINDO PHARMA LIMITED12/28/2006