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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-633 BETHANECHOL CHLORIDE TABLETS USP, 5 MG   UPSHER-SMITH LABORATORIES, INC. 6/1/2005 
2 40-634 BETHANECHOL CHLORIDE TABLETS USP, 10 MG   UPSHER-SMITH LABORATORIES, INC. 6/1/2005 
3 40-635 BETHANECHOL CHLORIDE TABLETS USP, 25 MG   UPSHER-SMITH LABORATORIES, INC. 6/1/2005 
4 40-636 BETHANECHOL CHLORIDE TABLETS USP, 50 MG   UPSHER-SMITH LABORATORIES, INC. 6/1/2005 
5 76-827 VINORELBINE 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 
6 40-611 PREDNISONE TABLETS USP, 1 MG   TRIGEN LABORATORIES, INC. 6/6/2005 
7 40-576 CARISOPRODOL TABLETS USP, 350 MG   NEIL LABORATORIES, INC. 6/7/2005 
8 77-026 ACYCLOVIR ORAL SUSPENSION USP, 200 MG/5 ML   HI-TECH PHARMACAL CO., INC. 6/7/2005 
9 76-643 CARBIDOPA AND LEVODOPA TABLETS FOR ORAL SUSPENSION 10 MG/100 MG, 25 MG/100 MG, AND 25 MG/250 MG   RANBAXY LABORATORIES LIMITED 6/10/2005 
10 40-514 FOLIC ACID TABLETS USP, 1 MG   TRIGEN LABORATORIES, INC. 6/14/2005 
11 77-096 CARBOPLATIN 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 
12 77-109 HALOBETASOL PROPIONATE OINTMENT 0.05%   ALPHARMA USPD INC. 6/14/2005 
13 77-145 FLUTICASONE PROPIONATE OINTMENT 0.005%   TARO PHARMACEUTICAL INDUSTRIES, LTD. 6/14/2005 
14 76-426 CIPROFLOXACIN TABLETS USP, 100 MG, 250 MG, 500 MG, AND 750 MG   PLIVA, INC. 6/15/2005 
15 76-516 CLOTRIMAZOLE & BETAMETHASONE DIPROPIONATE LOTION USP, 1%/0.05%(BASE)   ALTANA INC. 6/16/2005 
16 76-752 LEVOTHYROXINE 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 
17 76-469 CROMOLYN SODIUM INHALATION SOLUTION USP, 10 MG/ML; PACKAGED IN 20 MG/2 ML SINGLE- DOSE AMPULES   BREATH LIMITED 6/17/2005 
18 77-349 IBUPROFEN TABLETS USP, (OTC), 200 MG ORANGE-COATED, ROUND & CAPSULE-SHAPED   PERRIGO R&D COMPANY 6/21/2005 
19 76-463 HALOPERIDOL DECANOATE INJECTION 50 MG (BASE)/ML AND 100 MG (BASE)/ML   SABEX 2002 INC. 6/24/2005 
20 65-148 NYSTATIN ORAL SUSPENSION USP, 100,000 UNITS/ML   VINTAGE PHARMACEUTICALS, LLC 6/28/2005 
21 65-248 CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG   ORCHID HEALTHCARE 6/28/2005 
22 76-716 GLYBURIDE 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 
23 76-901 MIRTAZAPINE ORALLY DISINTEGRATING TABLETS 15 MG, 30 MG, AND 45 MG   TEVA PHARMACEUTICALS USA 6/28/2005 
24 77-196 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS USP, 100 MG/500 MG   ANDRX PHARMACEUTICALS, LLC 6/28/2005 
25 77-211 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG   RANBAXY LABORATORIES LIMITED 6/29/2005 
26 76-537 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 6/30/2005 
27 77-034 CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)   COBALT PHARMACEUTICALS, INC. 6/30/2005 
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