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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-513OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  NOVEX PHARMA5/14/2004 
275-988PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/ 5 ML  PADDOCK LABORATORIES, INC.5/25/2004 
365-178CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG  ROXANE LABORATORIES, INC.5/25/2004 
476-887TERBUTALINE SULFATE INJECTION, USP 1 MG/ML, PACKAGED IN 1 ML SINGLE-DOSE VIALS.  AMERICAN PHARMACEUTICAL PARTNERS, INC.5/26/2004 
575-914BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 150 MG (RLD = ZYBAN/GSK)  IMPAX LABORATORIES, INC.5/27/2004 
676-449MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5 MG  IMPAX LABORATORIES, INC.5/27/2004 
776-408METRONIDAZOLE TOPICAL CREAM 0.75%  ALTANA INC.5/28/2004 
840-540PROCHLORPERAZINE 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 LABORATORIES5/28/2004 
976-231OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  ALCON INC.5/14/2004 
1076-622OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  BAUSCH & LOMB, INC.5/14/2004 
1176-300FLUTICASONE PROPIONATE OINTMENT 0.005%  ALTANA INC.5/14/2004 
1276-743PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/325 MG  VINTAGE PHARMACEUTICALS, INC.5/7/2004 
1376-633FLUTICASONE PROPIONATE CREAM 0.05%  ATRIX LABORATORIES, INC,5/14/2004 
1476-668FLUTICASONE PROPIONATE OINTMENT 0.005%  CLAY-PARK LABS, INC.5/14/2004 
1576-793FLUTICASONE PROPIONATE CREAM 0.05%  CLAY-PARK LABS, INC.5/14/2004 
1676-451FLUTICASONE PROPIONATE CREAM 0.05%  ALTANA INC.5/14/2004 
1776-615OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%  HI-TECH PHARMACAL CO., INC.5/14/2004 
1876-458FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 ML  PAR PHARMACEUTICAL, INC.5/14/2004 
1976-521CARBIDOPA-LEVODOPA EXTENDED-RELEASE TABLETS 25 MG/100 MG, AND 50 MG/200 MG  IMPAX LABORATORIES, INC.5/14/2004 
2076-733MORPHINE SULFATE EXTENDED-RELEASE TABLETS 15 MG  KV PHARMACEUTICAL COMPANY5/19/2004 
2176-720MORPHINE SULFATE EXTENDED-RELEASE TABLETS 60 MG  KV PHARMACEUTICAL COMPANY5/19/2004 
2276-151DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG, AND 300 MG (ONCE-A-DAY DOSAGE)  TORPHARM INC.5/20/2004 
2365-089AMOXICILLIN & CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP 200 MG/28.5 MG (BASE)/5 ML AND 400 MG/57 MG (BASE)/5 ML  TEVA PHARMACEUTICALS USA5/25/2004 
2476-104ITRACONAZOLE CAPSULES 100 MG  EON LABS, INC.5/28/2004 
2576-216AMMONIUM LACTATE LOTION 12% (BASE)  TARO PHARMACEUTICALS USA, INC.5/28/2004