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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - February 2002

 ANDA NumberDrug NameApplicantTentative Approval Date
176-067MOMETASONE FUROATE OINTMENT, USP 0.1%CLAY-PARK LABS, INC.2/1/02
275-928CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%NOVEX PHARMA2/4/02
376-059LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MGWATSON LABORATORIES, INC.2/5/02
475-504QUINAPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MGTEVA PHARMACEUTICALS USA2/8/02
575-890GLYBURIDE TABLETS, USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MGAL-HIKMA PHARMACEUTICALS2/8/02
675-181PRENISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG(BASE)/5 MLWE PHARMACEUTICALS, INC.2/13/02
775-868FENOFIBRATE CAPSULES (MICRONIZED) 67 MG, 134 MG, AND 200 MGIMPAX LABORATORIES, INC.2/20/02
875-873MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/MLROXANE LABORATORIES, INC.2/25/02
976-176MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MGALPHAPHARM PTY LTD.2/25/02
1076-153PAMIDRONATE DISODIUM INJECTION 3 MG/ML (30 MG/10 ML SINGLE-USE VIAL), 9 MG/ML (90 MG/10 ML SINGLE-USE VIALGENSIA SICOR PHARMACEUTICALS, INC.2/28/02
1176-154LORATADINE TABLETS 10 MGGENPHARM INC.2/28/02