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U.S. Department of Health and Human Services

Drugs

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Approvals - January 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-474HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MGABLE LABORATORIES, INC.1/2/03
275-941STRONTIUM CHLORIDE Sr-89 INJECTION, USP 1 mCi/MlBIO-NUCLEONICS PHARMA, INC.1/6/03
376-266DOXAPRAM HYDROCHLORIDE INJECTION, USP 20 MG/ML (400 MG/20 ML) MULTIPLE- DOSE VIALBEDFORD LABORATORIES1/10/03
440-460PHENTERMINE HYDROCHLORIDE CAPSULES, USP 15 MGAMIDE PHARMACEUTICAL, INC.1/14/03
576-278FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGROXANE LABORATORIES, INC.1/14/03
676-375RIMANTADINE HYDROCHLORIDE TABLETS 100 MGAMIDE PHARMACEUTICAL, INC.1/14/03
740-425FLUDROCORTISONE ACETATE TABLETS, USP 0.1 MGBARR LABORATORIES, INC.1/21/03
875-209LORATADINE TABLETS (OTC) 10 MGGENEVA PHARMACEUTICALS, INC.1/21/03
940-432HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MGMIKART, INC.1/22/03
1040-443ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/15 MG, 300 MG/30 MG; AND 300 MG/60 MGANDRX PHARMACEUTICALS, INC.1/22/03
1140-448PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MGAMIDE PHARMACEUTICAL, INC.1/22/03
1276-383NIZATIDINE CAPSULES, USP 150 MG, AND 300 MGTORPHARM1/23/03
1375-800ETIDRONATE DISODIUM TABLETS, USP 200 MG AND 400 MGGENPHARM INC.1/24/03
1476-009NABUMETONE TABLETS 500 MG AND 750 MGIVAX PHARMACEUTICALS, INC.1/24/03
1576-119MIRTAZAPINE TABLETS 15 MG AND 30 MGTEVA PHARMACEUTICALS USA1/24/03
1675-757OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MGLEK PHARMACEUTICALS d.d.1/28/03
1740-489METHOCARBAMOL TABLETS, USP 500 MG AND 750 MGVINTAGE PHARMACEUTICALS, INC.1/29/03
1876-173RILUZOLE TABLETS 50 MGIMPAX LABORATORIES, INC.1/29/03
1976-050LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 5 MG/120 MG (12-HOUR FORMULATION) (OTC)IMPAX LABORATORIES1/30/03
2040-387BUTALBITAL, ACETAMINOPHEN, & CAFFEINE ORAL SOLUTION 50 MG/325 MG/40 MG, RESPECTIVELY, PER 15 MLMIKART, INC.1/31/03
2176-363DIGOXIN TABLETS, USP 0.125 MG AND 0.25 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.1/31/03