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U.S. Department of Health and Human Services

Drugs

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Approvals - March 2002

 ANDA NumberDrug NameApplicantApproval Date
175-385BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MGZENITH GOLDLINE PHARMACEUTICALS, INC.3/1/02
275-610FAMOTIDINE TABLETS, USP (OTC) 10 MGTORPHARM3/12/02
375-824BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML (1 MG/SPRAY), METERED-DOSE SPRAY PUMPROXANE LABORATORIES, INC.3/12/02
465-063AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG AND 125 MG (BASE), RESPECTIVELYGENEVA PHARMACEUTICALS, INC.3/14/02
575-119BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG AND 10 MGEGIS PHARMACEUTICALS, LTD.3/14/02
675-995IBUPROFEN TABLETS 200 MGL. PERRIGO COMPANY3/14/02
765-064AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG AND 125 MG (BASE), RESPECTIVELYGENEVA PHARMACEUTICALS, INC.3/15/02
875-737MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5%CLAY-PARK LABS, INC.3/15/02
976-058MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/MLRANBAXY LABORATORIES, LIMITED3/15/02
1040-431FLUDROCORTISONE ACETATE TABLETS, USP 0.1 MGIMPAX LABORATORIES3/18/02
1165-009ERYTHROMYCIN TOPICAL GEL, USP 2%GLADES PHARMACEUTICALS, INC.3/18/02
1276-067MOMETASONE FUROATE OINTMENT, USP 0.1%CLAY-PARK LABS, INC.3/18/02
1365-074AMPICILLIN AND SULBACTAM FOR INJECTION, USP 1.5 G [1 G (BASE)/500 MG (BASE)], AND 3 G [2 G (BASE)/1 G (BASE)]ESI LEDERLE3/19/02
1465-076AMPICILLIN AND SULBACTAM FOR INJECTION, USP 10 G (BASE)/5 G (BASE) SUPPLIED AS A 15 G PHARMACY BULK PACKAGEESI LEDERLE3/19/02
1575-413BUSPIRONE TABLETS, USP 5 MG, 10 MG, AND 15 MGGENEVA PHARMACEUTICALS, INC.3/19/02
1675-860DESONIDE LOTION 0.05%ALTANA INC.3/19/02
1776-200ACETAMINOPHEN EXTENDED-RELEASE TABLETS (OTC) 650 MGCOREPHARMA LLC3/19/02
1875-803LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG (21- AND 28-DAY CYCLES)BARR LABORATORIES, INC.3/20/02
1976-264NALTREXONE HYDROCHLORIDE TABLETS, USP 25 MG, 50 MG, AND 100 MGMALLINCKRODT INC.3/22/02
2076-153PAMIDRONATE DISODIUM INJECTION 3 MG/ML 9 MG/MLGENSIA SICOR PHARMACEUTICALS, INC.3/27/02
2140-398HYDROCORTISONE ACETATE CREAM, USP 2%FERNDALE LABORATORIES, INC.3/29/02
2240-412HYDROCHLOROTHIAZIDE TABLETS, USP 25 MG, AND 50 MGVINTAGE PHARMACEUTICALS, INC.3/29/02