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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2002

 

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-452ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MGABLE LABORATORIES, INC.8/1/02
240-459ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/60 MGABLE LABORATORIES, INC.8/1/02
376-233PACLITAXEL INJECTION 6 MG/ML (PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, 150 MG/25 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS)NAPRO BIOTHERAPEUTICS, INC.8/1/02
475-942FAMOTIDINE INJECTION 10 MG/ML (PACKAGED IN 40 MG/4 ML AND 200 MG/20 ML MULTIPLE-DOSE VIALS)APOTEX CORP.8/2/02
576-002CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05%ALPHARMA8/2/02
676-013MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALSINTERNATIONAL MEDICATION SYSTEMS, LTD.8/2/02
776-202PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 25 MG (BASE)/650 MGAMIDE PHARMACEUTICAL, INC.8/2/02
840-446MEPERIDINE HYDROCHLORIDE TABLETS, USP 50 MG AND 100 MGCARACO PHARMACEUTICAL LABORATORIES LTD.8/8/02
976-259MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/MLESI LEDERLE8/8/02
1076-070NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MGBIOVAIL LABORATORIES, INC.8/16/02
1140-454PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML AND 50 MG/MLGENSIA SICOR PHARMACEUTICALS, INC.8/22/02
1276-021TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)RANBAXY LABORATORIES LIMITED8/22/02
1375-514FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 MLMORTON GROVE PHARMACEUTICALS, INC.8/29/02
1465-079PENICILLIN G POTASSIUM FOR INJECTION, USP 1 MILLION UNITS/VIAL, 5 MILLION UNITS/VIAL, AND 20 MILLION UNITS/VIAL.BIOCHEMIE GmbH8/30/02
1575-478NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.5 MG/0.035 MG; 0.75 MG/0.035 MG; AND 1 MG/0.035 MG PACKAGED IN 21-DAY AND 28-DAY REGIMENSBARR LABORATORIES, INC.8/30/02
1676-029LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE CHEWABLE TABLETS 2 MG/125 MGL. PERRIGO COMPANY8/30/02
1776-132RIMANTADINE HYDROCHLORIDE TABLETS 100 MGIMPAX LABORATORIES, INC.8/30/02
1876-195RANITIDINE TABLETS, USP (OTC) 75 MG (BASE)L. PERRIGO COMPANY8/30/02