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U.S. Department of Health and Human Services

Drugs

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Approvals February 2001

  ANDA NUMBER DRUG NAME APPLICANT APPROVAL DATE
1 65-061 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE) 300 MG (BASE) RANBAXY LABORATORIES LIMITED 2/2/01
2 75-738 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG MALLINCKRODT INC. 2/2/01
3 75-548 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.5 MG/0.03 MG/75 MG WATSON LABORATORIES, INC. 2/5/01
4 75-647 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.0 MG/0.02 MG) WATSON LABORATORIES, INC. 2/5/01
5 40-410 METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MG DANBURY PHARMACAL, INC. 2/9/01
6 75-338 CLOBETASOL PROPIONATE CREAM, USP 0.05% STIEFEL LABORATORIES, INC. 2/9/01
7 75-848 OXAPROZIN TABLETS 600 MG WATSON LABORATORIES, INC. 2/9/01
8 75-129 ALBUTEROL SULFATE INHALATION SOLUTION 0.083% (BASE) ROXANE LABORATORIES, INC. 2/13/01
9 75-837 FLOXURIDINE FOR INJECTION, USP 500 MG/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC. 2/22/01
10 75-582 DICLOFENAC POTASSIUM TABLETS 50 MG EON LABS MANUFACTURING, INC. 2/23/01
11 65-068 PENICILLIN G SODIUM FOR INJECTION, USP 5,000,000 UNITS/VIAL BIOCHEMIE GMBH 2/26/01
12 40-396 HYDROCORTISONE ACETATE CREAM, USP 2.5% FERNDALE LABORATORIES, INC. 2/27/01
13 75-402 METAPROTERENOL SULFATE INHALATION SOLUTION, USP 0.4% NOVEX PHARMA 2/28/01
14 75-403 METAPROTERENOL SULFATE INHALATION SOLUTION, USP 0.6% NOVEX PHARMA 2/28/01
15 75-847 OXAPROZIN TABLETS 600 MG GENPHARM,INC. 2/28/01
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