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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2002

 ANDA NumberDrug NameApplicantApproval Date
165-066AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 MLGENEVA PHARMACEUTICALS, INC.6/5/02
275-714CARBAMAZEPINE ORAL SUSPENSION, USP 100 MG/5 MLMORTON GROVE PHARMACEUTICALS, INC.6/5/02
375-991LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGCARLSBAD TECHNOLOGY, INC.6/5/02
476-187LEVOTHYROXINE SODIUM TABLETS, USP 0.025 MG, 0.05 MG, 0.075 MG, 0.088 MG, 0.1 MG, 0.112 MG, 0.125 MG, 0.15 MG, 0.175 MG, 0.2 MG, AND 0.3 MGMYLAN PHARMACEUTICALS INC.6/5/02
576-170LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 300 MGBARR LABORATORIES, INC.6/10/02
675-575AMMONIUM LACTATE LOTION 12% (BASE)PADDOCK LABORATORIES, INC.6/11/02
775-589TRETINOIN GEL, USP 0.01%SPEAR PHARMACEUTICALS, INC.6/11/02
875-856MIDAZOLAM HYDROCHLORIDE INJECTION (PRESERVATIVE-FREE) 1 MG (BASE)/ML AND 5 MG (BASE)/ML PACKAGED IN CARPUJECT SYRINGEABBOTT LABORATORIES6/13/02
940-439AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 10 MG (TOTAL), 20 MG (TOTAL), AND 30 MG (TOTAL)EON LABS, INC.6/14/02
1040-444AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL), 20 MG (TOTAL), AND 30 MG (TOTAL)COREPHARMA LLC6/19/02
1175-960TRAMADOL HYDROCHLORIDE TABLETS 50 MGPUREPAC PHARMACEUTICAL CO.6/19/02
1275-964TRAMADOL HYDROCHLORIDE TABLETS 50 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.6/19/02
1375-977TRAMADOL HYDROCHLORIDE TABLETS 50 MGTEVA PHARMACEUTICALS USA6/19/02
1476-003TRAMADOL HYDROCHLORIDE TABLETS 50 MGCOREPHARMA LLC6/20/02
1576-100TRAMADOL HYDROCHLORIDE TABLETS 50 MGMUTUAL PHARMACEUTICAL COMPANY6/20/02
1675-986TRAMADOL HYDROCHLORIDE TABLETS 50 MGMYLAN PHARMACEUTICALS, INC.6/21/02
1775-962TRAMADOL HYDROCHLORIDE TABLETS 50 MGWATSON LABORATORIES, INC.6/24/02
1875-968TRAMADOL HYDROCHLORIDE TABLETS 50 MGEON LABS, INC.6/25/02
1975-983TRAMADOL HYDROCHLORIDE TABLETS 50 MGMALLINCKRODT INC.6/25/02
2075-525FLUOXETINE ORAL SOLUTION, USP 20 MG/5 MLHI-TECH PHARMACAL CO., INC.6/27/02
2175-841PAMIDRONATE DISODIUM INJECTION 3 MG/ML (30 MG/10 ML), 6 MG/ML (60 MG/10 ML), AND 9 MG/ML (90 MG/10 ML) SINGLE-USE VIALSFAULDING PHARMACEUTICAL COMPANY6/27/02
2276-243LITHIUM CARBONATE CAPSULES, USP 300 MGWEST-WARD PHARMACEUTICAL CORP.6/27/02
2376-257GLYBURIDE TABLETS, USP (NONMICRONIZED) 1.25 MG, 2.5 MG, AND 5 MGCOREPHARMA LLC6/27/02
2476-280TIZANIDINE HYDROCHLORIDE TABLETS 4 MG (BASE)EON LABS, INC.6/27/02
2575-099PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 MLMORTON GROVE PHARMACEUTICALS, INC.6/28/02