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U.S. Department of Health and Human Services

Drugs

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Approvals February 2001

 ANDA NUMBERDRUG NAMEAPPLICANTAPPROVAL DATE
165-061CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE) 300 MG (BASE)RANBAXY LABORATORIES LIMITED2/2/01
275-738PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MGMALLINCKRODT INC.2/2/01
375-548NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.5 MG/0.03 MG/75 MGWATSON LABORATORIES, INC.2/5/01
475-647NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.0 MG/0.02 MG)WATSON LABORATORIES, INC.2/5/01
540-410METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MGDANBURY PHARMACAL, INC.2/9/01
675-338CLOBETASOL PROPIONATE CREAM, USP 0.05%STIEFEL LABORATORIES, INC.2/9/01
775-848OXAPROZIN TABLETS 600 MGWATSON LABORATORIES, INC.2/9/01
875-129ALBUTEROL SULFATE INHALATION SOLUTION 0.083% (BASE)ROXANE LABORATORIES, INC.2/13/01
975-837FLOXURIDINE FOR INJECTION, USP 500 MG/VIALAMERICAN PHARMACEUTICAL PARTNERS, INC.2/22/01
1075-582DICLOFENAC POTASSIUM TABLETS 50 MGEON LABS MANUFACTURING, INC.2/23/01
1165-068PENICILLIN G SODIUM FOR INJECTION, USP 5,000,000 UNITS/VIALBIOCHEMIE GMBH2/26/01
1240-396HYDROCORTISONE ACETATE CREAM, USP 2.5%FERNDALE LABORATORIES, INC.2/27/01
1375-402METAPROTERENOL SULFATE INHALATION SOLUTION, USP 0.4%NOVEX PHARMA2/28/01
1475-403METAPROTERENOL SULFATE INHALATION SOLUTION, USP 0.6%NOVEX PHARMA2/28/01
1575-847OXAPROZIN TABLETS 600 MGGENPHARM,INC.2/28/01