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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2002

  ANDA Number Drug Name Applicant Tentative Approval Date
1 76-223 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG GENEVA PHARMACEUTICALS TECHNOLOGY CORPOR 5/6/02
2 76-018 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (3 ML VIAL) BEDFORD LABORATORIES 5/7/02
3 76-104 ITRACONAZOLE CAPSULES 100 MG EON LABS MANUFACTURING, INC. 5/8/02
4 76-123 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML PHARMACEUTICAL ASSOCIATES, INC. 5/13/02
5 76-231 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% ALCON UNIVERSAL, LTD. 5/13/02
6 76-056 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS USA 5/15/02
7 76-235 CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG PER SINGLE-DOSE VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC. 5/22/02
8 75-989 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (24-HOUR FORMULATION) IMPAX LABORATORIES, INC. 5/24/02
9 76-036 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) PAR PHARMACEUTICAL, INC. 5/24/02
10 76-050 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION) IMPAX LABORATORIES, INC. 5/29/02
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