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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-510DESOXIMETASONE CREAM, USP 0.25%  CLAY-PARK LABS, INC.7/1/2003 
276-222GANCICLOVIR SODIUM FOR INJECTION 500 MG (BASE)/VIAL  BEDFORD LABORATORIES7/16/2003 
376-242CALCITRIOL ORAL SOLUTION 1 MCG/ML  ROXANE LABORATORIES, INC.7/18/2003 
465-135CEFUROXIME AXETIL TABLETS, USP 250 MG 500 MG  LUPIN LIMITED7/25/2003 
576-645LACTULOSE SOLUTION, USP 10 G/15 ML  NOVEX PHARMA7/28/2003 
640-417HYDROCORTISONE LOTION, USP 2.5%  VINTAGE PHARMACEUTICALS, INC.7/30/2003 
775-356PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)  TORPHARM7/30/2003 
840-507PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 65 MG/650 MG  VINTAGE PHARMACEUTICALS, INC.7/30/2003 
975-890GLYBURIDE TABLETS, USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MG  HIKMA PHARMACEUTICALS7/31/2003 
1076-412MORPHINE SULFATE EXTENDED-RELEASE TABLETS 15 MG, 30 MG, AND 60 MG  MALLINCKRODT INC.7/31/2003 
1165-095DOXYCYCLINE HYCLATE TABLETS, USP 100 MG (BASE)  WEST-WARD PHARMACEUTICAL CORP.7/2/2003 
1276-438MORPHINE SULFATE EXTENDED-RELEASE TABLETS 100 MG AND 200 MG  MALLINCKRODT INC.7/3/2003 
1376-495METOPROLOL TARTRATE INJECTION, USP 1 MG/ML, PACKAGED IN 5 MG/5 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES7/7/2003