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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-427 CROMOLYN SODIUM NASAL SOLUTION, USP (OTC) 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 13 ML & 26 ML METERED SPRAY BOTTLES L. PERRIGO COMPANY 12/12/01
2 75-639 FAMOTIDINE TABLETS, USP 20 MG AND 40 MG MUTUAL PHARMACEUTICAL COMPANY, INC. 12/12/01
3 75-661 IBUPROFEN TABLETS, USP (OTC) 200 MG BASF CORPORATION 12/12/01
4 76-152 DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MG MYLAN PHARMACEUTICALS, INC. 12/13/01
5 75-300 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG GENEVA PHARMACEUTICALS, INC. 12/17/01
6 75-451 LOVASTATIN TABLETS, USP 10 MG, 20 MG AND 40 MG MYLAN PHARMACEUTICALS, INC. 12/17/01
7 75-551 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS USA 12/17/01
8 75-636 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG EON LABS MANUFACTURING, INC. 12/17/01
9 75-729 FAMOTIDINE INJECTION 0.4 MG/ML ABBOTT LABORATORIES 12/17/01
10 75-828 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG PUREPAC PHARMACEUTICAL CO. 12/17/01
11 75-935 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG GENPHARM INC. 12/17/01
12 65-054 CYCLOSPORINE ORAL SOLUTION USP (MODIFIED) 100 MG/ML SIDMAK LABORATORIES, INC. 12/18/01
13 75-927 NAPROXEN TABLETS, USP 250 MG 375 MG 500 MG INTERPHARM, INC. 12/18/01
14 76-090 PERMETHRIN LOTION 1% CLAY-PARK LABS., INC. 12/20/01
15 75-450 METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MG PUREPAC PHARMACEUTICAL CO. 12/21/01
16 75-674 FAMOTIDINE TABLETS, USP (OTC) 10 MG GENPHARM INC. 12/21/01
17 76-092 KETAMINE HYDROCHLORIDE INJECTION, USP 50 MG (BASE)/ML BIONICHE PHARMA (CANADA) LTD. 12/28/01
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