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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-510 DESOXIMETASONE CREAM, USP 0.25%   CLAY-PARK LABS, INC. 7/1/2003 
2 76-222 GANCICLOVIR SODIUM FOR INJECTION 500 MG (BASE)/VIAL   BEDFORD LABORATORIES 7/16/2003 
3 76-242 CALCITRIOL ORAL SOLUTION 1 MCG/ML   ROXANE LABORATORIES, INC. 7/18/2003 
4 65-135 CEFUROXIME AXETIL TABLETS, USP 250 MG 500 MG   LUPIN LIMITED 7/25/2003 
5 76-645 LACTULOSE SOLUTION, USP 10 G/15 ML   NOVEX PHARMA 7/28/2003 
6 40-417 HYDROCORTISONE LOTION, USP 2.5%   VINTAGE PHARMACEUTICALS, INC. 7/30/2003 
7 75-356 PAROXETINE HYDROCHLORIDE TABLETS 10 MG (BASE), 20 MG (BASE), 30 MG (BASE), AND 40 MG (BASE)   TORPHARM 7/30/2003 
8 40-507 PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 65 MG/650 MG   VINTAGE PHARMACEUTICALS, INC. 7/30/2003 
9 75-890 GLYBURIDE TABLETS, USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MG   HIKMA PHARMACEUTICALS 7/31/2003 
10 76-412 MORPHINE SULFATE EXTENDED-RELEASE TABLETS 15 MG, 30 MG, AND 60 MG   MALLINCKRODT INC. 7/31/2003 
11 65-095 DOXYCYCLINE HYCLATE TABLETS, USP 100 MG (BASE)   WEST-WARD PHARMACEUTICAL CORP. 7/2/2003 
12 76-438 MORPHINE SULFATE EXTENDED-RELEASE TABLETS 100 MG AND 200 MG   MALLINCKRODT INC. 7/3/2003 
13 76-495 METOPROLOL TARTRATE INJECTION, USP 1 MG/ML, PACKAGED IN 5 MG/5 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 7/7/2003

 

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