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U.S. Department of Health and Human Services

Drugs

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Approvals - August 2001

  ANDA Number Drug Name Applicant Approval Date
1 74-803 FLUOXETINE CAPSULES, USP 20 MG BARR LABORATORIES, INC. 8/2/01
2 75-049 FLUOXETINE CAPSULES, USP 10 MG GENEVA PHARMACEUTICALS, INC. 8/2/01
3 75-465 FLUOXETINE CAPSULES, USP 40 MG DR. REDDY'S LABORATORIES LIMITED 8/2/01
4 75-506 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML TEVA PHARMACEUTICALS, USA 8/2/01
5 75-755 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG, AND 20 MG ALPHAPHARM PTY. LTD. 8/2/01
6 75-720 METIPRANOLOL OPHTHALMIC SOLUTION 0.3% FALCON PHARMACEUTICALS, LTD. 8/6/01
7 75-759 BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML (1 MG/SPRAY); 2.5 ML METERED-DOSE SPRAY PUMP ESI LEDERLE 8/8/01
8 65-013 TOBRAMYCIN FOR INJECTION, USP 1.2 G PHARMACY BULK PACKAGE PHARMA-TEK INC. 8/17/01
9 75-758 FAMOTIDINE TABLETS, USP (OTC) 10 MG DR. REDDY'S LABORATORIES LIMITED 8/17/01
10 75-851 OXAPROZIN TABLETS 600 MG MYLAN PHARMACEUTICALS, INC. 8/17/01
11 75-918 FLUPHENAZINE DECANOATE INJECTION, USP 25 MG/ML APOTEX CORP. 8/17/01
12 40-424 SPIRONOLACTONE TABLETS, USP 25 MG, 50 MG, AND 100 MG MYLAN PHARMACEUTICALS, INC. 8/20/01
13 74-911 BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50MG/325MG/40MG/30MG AMARIN PHARMACEUTICALS, INC. 8/22/01
14 75-733 CLOBETASOL PROPIONATE CREAM, USP (EMOLLIENT) 0.05% STIEFEL LABORATORIES, INC. 8/22/01
15 40-362 PREDNISONE TABLETS, USP 5 MG, AND 10 MG TRIGEN LABORATORIES, INC. 8/29/01
16 76-035 HALOPERIDOL INJECTION, USP 5 MG (BASE)/ML; 1 ML SINGLE-DOSE VIALS AND 10 ML MULTIPLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC. 8/29/01
17 76-045 LORAZEPAM TABLETS, USP 0.5 MG, 1 MG, AND 2 MG RANBAXY LABORATORIES LIMITED 8/29/01
18 40-402 PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG ABLE LABORATORIES, INC. 8/30/01
19 40-403 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG (YELLOW) ABLE LABORATORIES, INC. 8/30/01
20 40-427 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG (BLUE/CLEAR) ABLE LABORATORIES, INC. 8/30/01
21 75-826 PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 MG/ML (1 ML VIAL) AMERICAN PHARMACEUTICAL PARTNERS, INC. 8/31/01

 

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