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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-513 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   NOVEX PHARMA 5/14/2004 
2 75-988 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/ 5 ML   PADDOCK LABORATORIES, INC. 5/25/2004 
3 65-178 CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG   ROXANE LABORATORIES, INC. 5/25/2004 
4 76-887 TERBUTALINE SULFATE INJECTION, USP 1 MG/ML, PACKAGED IN 1 ML SINGLE-DOSE VIALS.   AMERICAN PHARMACEUTICAL PARTNERS, INC. 5/26/2004 
5 75-914 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 150 MG (RLD = ZYBAN/GSK)   IMPAX LABORATORIES, INC. 5/27/2004 
6 76-449 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5 MG   IMPAX LABORATORIES, INC. 5/27/2004 
7 76-408 METRONIDAZOLE TOPICAL CREAM 0.75%   ALTANA INC. 5/28/2004 
8 40-540 PROCHLORPERAZINE EDISYLATE INJECTION, USP 5 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/2 ML SINGLE-DOSE VIALS AND 50 MG (BASE)/10 ML MULTIPLE-DOSE VIALS   BEDFORD LABORATORIES 5/28/2004 
9 76-231 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   ALCON INC. 5/14/2004 
10 76-622 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   BAUSCH & LOMB, INC. 5/14/2004 
11 76-300 FLUTICASONE PROPIONATE OINTMENT 0.005%   ALTANA INC. 5/14/2004 
12 76-743 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/325 MG   VINTAGE PHARMACEUTICALS, INC. 5/7/2004 
13 76-633 FLUTICASONE PROPIONATE CREAM 0.05%   ATRIX LABORATORIES, INC, 5/14/2004 
14 76-668 FLUTICASONE PROPIONATE OINTMENT 0.005%   CLAY-PARK LABS, INC. 5/14/2004 
15 76-793 FLUTICASONE PROPIONATE CREAM 0.05%   CLAY-PARK LABS, INC. 5/14/2004 
16 76-451 FLUTICASONE PROPIONATE CREAM 0.05%   ALTANA INC. 5/14/2004 
17 76-615 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%   HI-TECH PHARMACAL CO., INC. 5/14/2004 
18 76-458 FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 ML   PAR PHARMACEUTICAL, INC. 5/14/2004 
19 76-521 CARBIDOPA-LEVODOPA EXTENDED-RELEASE TABLETS 25 MG/100 MG, AND 50 MG/200 MG   IMPAX LABORATORIES, INC. 5/14/2004 
20 76-733 MORPHINE SULFATE EXTENDED-RELEASE TABLETS 15 MG   KV PHARMACEUTICAL COMPANY 5/19/2004 
21 76-720 MORPHINE SULFATE EXTENDED-RELEASE TABLETS 60 MG   KV PHARMACEUTICAL COMPANY 5/19/2004 
22 76-151 DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG, AND 300 MG (ONCE-A-DAY DOSAGE)   TORPHARM INC. 5/20/2004 
23 65-089 AMOXICILLIN & CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP 200 MG/28.5 MG (BASE)/5 ML AND 400 MG/57 MG (BASE)/5 ML   TEVA PHARMACEUTICALS USA 5/25/2004 
24 76-104 ITRACONAZOLE CAPSULES 100 MG   EON LABS, INC. 5/28/2004 
25 76-216 AMMONIUM LACTATE LOTION 12% (BASE)   TARO PHARMACEUTICALS USA, INC. 5/28/2004 
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