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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INC. 1/2/03
2 75-941 STRONTIUM CHLORIDE Sr-89 INJECTION, USP 1 mCi/Ml BIO-NUCLEONICS PHARMA, INC. 1/6/03
3 76-266 DOXAPRAM HYDROCHLORIDE INJECTION, USP 20 MG/ML (400 MG/20 ML) MULTIPLE- DOSE VIAL BEDFORD LABORATORIES 1/10/03
4 40-460 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 15 MG AMIDE PHARMACEUTICAL, INC. 1/14/03
5 76-278 FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG ROXANE LABORATORIES, INC. 1/14/03
6 76-375 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG AMIDE PHARMACEUTICAL, INC. 1/14/03
7 40-425 FLUDROCORTISONE ACETATE TABLETS, USP 0.1 MG BARR LABORATORIES, INC. 1/21/03
8 75-209 LORATADINE TABLETS (OTC) 10 MG GENEVA PHARMACEUTICALS, INC. 1/21/03
9 40-432 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG MIKART, INC. 1/22/03
10 40-443 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/15 MG, 300 MG/30 MG; AND 300 MG/60 MG ANDRX PHARMACEUTICALS, INC. 1/22/03
11 40-448 PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG AMIDE PHARMACEUTICAL, INC. 1/22/03
12 76-383 NIZATIDINE CAPSULES, USP 150 MG, AND 300 MG TORPHARM 1/23/03
13 75-800 ETIDRONATE DISODIUM TABLETS, USP 200 MG AND 400 MG GENPHARM INC. 1/24/03
14 76-009 NABUMETONE TABLETS 500 MG AND 750 MG IVAX PHARMACEUTICALS, INC. 1/24/03
15 76-119 MIRTAZAPINE TABLETS 15 MG AND 30 MG TEVA PHARMACEUTICALS USA 1/24/03
16 75-757 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG LEK PHARMACEUTICALS d.d. 1/28/03
17 40-489 METHOCARBAMOL TABLETS, USP 500 MG AND 750 MG VINTAGE PHARMACEUTICALS, INC. 1/29/03
18 76-173 RILUZOLE TABLETS 50 MG IMPAX LABORATORIES, INC. 1/29/03
19 76-050 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION) (OTC) IMPAX LABORATORIES 1/30/03
20 40-387 BUTALBITAL, ACETAMINOPHEN, & CAFFEINE ORAL SOLUTION 50 MG/325 MG/40 MG, RESPECTIVELY, PER 15 ML MIKART, INC. 1/31/03
21 76-363 DIGOXIN TABLETS, USP 0.125 MG AND 0.25 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 1/31/03
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