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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-422CICLOPIROX TOPICAL SUSPENSION USP, 0.77% (LOTION) 0.77%  ALTANA, INC.8/6/2004 
275-115NITROGLYCERIN TRANSDERMAL SYSTEM 0.2 MG/HOUR AND 0.4 MG/HOUR  SCHWARZ PHARMA, INC.8/10/2004 
376-323ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; PACKAGED IN 100 MG/10 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES8/10/2004 
476-851LEVOCARNITINE ORAL SOLUTION, USP 1 G/10 ML  LYNE LABORATORIES, INC.8/10/2004 
540-612METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP 1 GRAM (BASE)/VIAL  AMERICAN PHARMACEUTICAL PARTNERS, INC.8/12/2004 
676-368POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP 20 mEq  EURAND INC.8/18/2004 
776-414MILRINONE LACTATE IN 5% DEXTROSE INJECTION 20 MG (BASE)/100 ML SINGLE-DOSE PLASTIC CONTAINER  B. BRAUN MEDICAL, INC.8/18/2004 
877-025NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS) 100 MG  MYLAN PHARMACEUTICALS, INC.8/18/2004 
975-728LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML  L. PERRIGO COMPANY8/20/2004 
1075-815LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML  MORTON GROVE PHARMACEUTICALS, INC.8/20/2004 
1176-529LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML  RANBAXY LABORATORIES LIMITED8/20/2004 
1276-792METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 50 MG/25 MG, 100 MG/25 MG, AND 100 MG/50 MG  MYLAN PHARMACEUTICALS, INC.8/20/2004 
1376-805LORATADINE ORAL SOLUTION, USP (OTC) 5 MG/5 ML  TARO PHARMACEUTICAL INDUSTRIES LTD.8/20/2004 
1476-239MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) (OTC) 5%  HARMONY LABS, INC.8/24/2004 
1576-774HALOPERIDOL INJECTION, USP (PRESERVATIVE-FREE) 5 MG (BASE)/ML; PACKAGED IN 5 MG (BASE)/1 ML SYRINGES  APOTEX CORP.8/25/2004 
1676-791HALOPERIDOL INJECTION, USP (PRESERVATIVE-FREE) 5 MG (BASE)/ML; PACKAGED IN 5 MG (BASE)/1 ML SINGLE-USE VIALS  APOTEX CORP.8/25/2004 
1776-814DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MG  ABLE LABORATORIES, INC.8/25/2004 
1876-828HALOPERIDOL INJECTION, USP 5 MG (BASE)/ML; PACKAGED IN 50 MG (BASE)/10 ML MULTIPLE-DOSE VIALS  APOTEX CORP.8/25/2004 
1976-870ALLOPURINOL SODIUM FOR INJECTION 500 MG (BASE)/VIAL  BEDFORD LABORATORIES8/26/2004 
2040-564DOXYLAMINE SUCCINATE TABLETS, USP (OTC) 25 MG  LNK INTERNATIONAL, INC.8/27/2004 
2176-699CARBIDOPA AND LEVODOPA ORALLY DISINTEGRATING TABLETS 10 MG/100 MG, 25 MG/100 MG, AND 25 MG/250 MG  SCHWARZ PHARMA, INC.8/27/2004 
2276-830OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  PHARMAFORCE, INC.8/31/2004