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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-633BETHANECHOL CHLORIDE TABLETS USP, 5 MG  UPSHER-SMITH LABORATORIES, INC.6/1/2005 
240-634BETHANECHOL CHLORIDE TABLETS USP, 10 MG  UPSHER-SMITH LABORATORIES, INC.6/1/2005 
340-635BETHANECHOL CHLORIDE TABLETS USP, 25 MG  UPSHER-SMITH LABORATORIES, INC.6/1/2005 
440-636BETHANECHOL CHLORIDE TABLETS USP, 50 MG  UPSHER-SMITH LABORATORIES, INC.6/1/2005 
576-827VINORELBINE TARTRATE INJECTION, 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG (BASE)/5 ML SINGLE-USE VIALS  MAYNE PHARMA (USA), INC.6/2/2005 
640-611PREDNISONE TABLETS USP, 1 MG  TRIGEN LABORATORIES, INC.6/6/2005 
740-576CARISOPRODOL TABLETS USP, 350 MG  NEIL LABORATORIES, INC.6/7/2005 
877-026ACYCLOVIR ORAL SUSPENSION USP, 200 MG/5 ML  HI-TECH PHARMACAL CO., INC.6/7/2005 
976-643CARBIDOPA AND LEVODOPA TABLETS FOR ORAL SUSPENSION 10 MG/100 MG, 25 MG/100 MG, AND 25 MG/250 MG  RANBAXY LABORATORIES LIMITED6/10/2005 
1040-514FOLIC ACID TABLETS USP, 1 MG  TRIGEN LABORATORIES, INC.6/14/2005 
1177-096CARBOPLATIN INJECTION 10 MG/ML; PACKAGED IN 50 MG/5 ML, 150 MG/15 ML, AND 450 MG/45 ML MULTIPLE-DOSE VIALS  SPECTRUM PHARMACEUTICALS, INC.6/14/2005 
1277-109HALOBETASOL PROPIONATE OINTMENT 0.05%  ALPHARMA USPD INC.6/14/2005 
1377-145FLUTICASONE PROPIONATE OINTMENT 0.005%  TARO PHARMACEUTICAL INDUSTRIES, LTD.6/14/2005 
1476-426CIPROFLOXACIN TABLETS USP, 100 MG, 250 MG, 500 MG, AND 750 MG  PLIVA, INC.6/15/2005 
1576-516CLOTRIMAZOLE & BETAMETHASONE DIPROPIONATE LOTION USP, 1%/0.05%(BASE)  ALTANA INC.6/16/2005 
1676-752LEVOTHYROXINE SODIUM TABLETS USP, 0.025 MG, 0.05 MG, 0.075 MG, 0.088 MG, 0.1 MG, 0.112 MG, 0.125 MG, 0.15 MG, 0.175 MG, 0.2 MG, AND 0.3 MG  GENPHARM INC.6/16/2005 
1776-469CROMOLYN SODIUM INHALATION SOLUTION USP, 10 MG/ML; PACKAGED IN 20 MG/2 ML SINGLE- DOSE AMPULES  BREATH LIMITED6/17/2005 
1877-349IBUPROFEN TABLETS USP, (OTC), 200 MG ORANGE-COATED, ROUND & CAPSULE-SHAPED  PERRIGO R&D COMPANY6/21/2005 
1976-463HALOPERIDOL DECANOATE INJECTION 50 MG (BASE)/ML AND 100 MG (BASE)/ML  SABEX 2002 INC.6/24/2005 
2065-148NYSTATIN ORAL SUSPENSION USP, 100,000 UNITS/ML  VINTAGE PHARMACEUTICALS, LLC6/28/2005 
2165-248CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG  ORCHID HEALTHCARE6/28/2005 
2276-716GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS 1.25 MG/250 MG, 2.5 MG/500 MG, AND 5 MG/500 MG  PUREPAC PHARMACEUTICAL CO.6/28/2005 
2376-901MIRTAZAPINE ORALLY DISINTEGRATING TABLETS 15 MG, 30 MG, AND 45 MG  TEVA PHARMACEUTICALS USA6/28/2005 
2477-196PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS USP, 100 MG/500 MG  ANDRX PHARMACEUTICALS, LLC6/28/2005 
2577-211METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  RANBAXY LABORATORIES LIMITED6/29/2005 
2676-537GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.6/30/2005 
2777-034CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  COBALT PHARMACEUTICALS, INC.6/30/2005