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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-422 CICLOPIROX TOPICAL SUSPENSION USP, 0.77% (LOTION) 0.77%   ALTANA, INC. 8/6/2004 
2 75-115 NITROGLYCERIN TRANSDERMAL SYSTEM 0.2 MG/HOUR AND 0.4 MG/HOUR   SCHWARZ PHARMA, INC. 8/10/2004 
3 76-323 ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 8/10/2004 
4 76-851 LEVOCARNITINE ORAL SOLUTION, USP 1 G/10 ML   LYNE LABORATORIES, INC. 8/10/2004 
5 40-612 METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP 1 GRAM (BASE)/VIAL   AMERICAN PHARMACEUTICAL PARTNERS, INC. 8/12/2004 
6 76-368 POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 20 mEq   EURAND INC. 8/18/2004 
7 76-414 MILRINONE LACTATE IN 5% DEXTROSE INJECTION 20 MG (BASE)/100 ML SINGLE-DOSE PLASTIC CONTAINER   B. BRAUN MEDICAL, INC. 8/18/2004 
8 77-025 NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS) 100 MG   MYLAN PHARMACEUTICALS, INC. 8/18/2004 
9 75-728 LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML   L. PERRIGO COMPANY 8/20/2004 
10 75-815 LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML   MORTON GROVE PHARMACEUTICALS, INC. 8/20/2004 
11 76-529 LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML   RANBAXY LABORATORIES LIMITED 8/20/2004 
12 76-792 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 50 MG/25 MG, 100 MG/25 MG, AND 100 MG/50 MG   MYLAN PHARMACEUTICALS, INC. 8/20/2004 
13 76-805 LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML   TARO PHARMACEUTICAL INDUSTRIES LTD. 8/20/2004 
14 76-239 MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) (OTC) 5%   HARMONY LABS, INC. 8/24/2004 
15 76-774 HALOPERIDOL INJECTION, USP (PRESERVATIVE-FREE) 5 MG (BASE)/ML; PACKAGED IN 5 MG (BASE)/1 ML SYRINGES   APOTEX CORP. 8/25/2004 
16 76-791 HALOPERIDOL INJECTION, USP (PRESERVATIVE-FREE) 5 MG (BASE)/ML; PACKAGED IN 5 MG (BASE)/1 ML SINGLE-USE VIALS   APOTEX CORP. 8/25/2004 
17 76-814 DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MG   ABLE LABORATORIES, INC. 8/25/2004 
18 76-828 HALOPERIDOL INJECTION, USP 5 MG (BASE)/ML; PACKAGED IN 50 MG (BASE)/10 ML MULTIPLE-DOSE VIALS   APOTEX CORP. 8/25/2004 
19 76-870 ALLOPURINOL SODIUM FOR INJECTION 500 MG (BASE)/VIAL   BEDFORD LABORATORIES 8/26/2004 
20 40-564 DOXYLAMINE SUCCINATE TABLETS, USP (OTC) 25 MG   LNK INTERNATIONAL, INC. 8/27/2004 
21 76-699 CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS 10 MG/100 MG, 25 MG/100 MG, AND 25 MG/250 MG   SCHWARZ PHARMA, INC. 8/27/2004 
22 76-830 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   PHARMAFORCE, INC. 8/31/2004 

 

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