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U.S. Department of Health and Human Services

Drugs

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Tentative Approvals - May 2002

 ANDA NumberDrug NameApplicantTentative Approval Date
176-223METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MGGENEVA PHARMACEUTICALS TECHNOLOGY CORPOR5/6/02
276-018AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (3 ML VIAL)BEDFORD LABORATORIES5/7/02
376-104ITRACONAZOLE CAPSULES 100 MGEON LABS MANUFACTURING, INC.5/8/02
476-123PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 MLPHARMACEUTICAL ASSOCIATES, INC.5/13/02
576-231OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3%ALCON UNIVERSAL, LTD.5/13/02
676-056PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MGTEVA PHARMACEUTICALS USA5/15/02
776-235CARBOPLATIN FOR INJECTION, USP 50 MG, 150 MG, AND 450 MG PER SINGLE-DOSE VIALAMERICAN PHARMACEUTICAL PARTNERS, INC.5/22/02
875-989LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (24-HOUR FORMULATION)IMPAX LABORATORIES, INC.5/24/02
976-036QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)PAR PHARMACEUTICAL, INC.5/24/02
1076-050LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION)IMPAX LABORATORIES, INC.5/29/02