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Tentative Approvals - February 2002

  ANDA Number Drug Name Applicant Tentative Approval Date
1 76-067 MOMETASONE FUROATE OINTMENT, USP 0.1% CLAY-PARK LABS, INC. 2/1/02
2 75-928 CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% NOVEX PHARMA 2/4/02
3 76-059 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG WATSON LABORATORIES, INC. 2/5/02
4 75-504 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS USA 2/8/02
5 75-890 GLYBURIDE TABLETS, USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MG AL-HIKMA PHARMACEUTICALS 2/8/02
6 75-181 PRENISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG(BASE)/5 ML WE PHARMACEUTICALS, INC. 2/13/02
7 75-868 FENOFIBRATE CAPSULES (MICRONIZED) 67 MG, 134 MG, AND 200 MG IMPAX LABORATORIES, INC. 2/20/02
8 75-873 MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML ROXANE LABORATORIES, INC. 2/25/02
9 76-176 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG ALPHAPHARM PTY LTD. 2/25/02
10 76-153 PAMIDRONATE DISODIUM INJECTION 3 MG/ML (30 MG/10 ML SINGLE-USE VIAL), 9 MG/ML (90 MG/10 ML SINGLE-USE VIAL GENSIA SICOR PHARMACEUTICALS, INC. 2/28/02
11 76-154 LORATADINE TABLETS 10 MG GENPHARM INC. 2/28/02

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