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U.S. Department of Health and Human Services

Drugs

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Approvals - November 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-916 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG COREPHARMA LLC 11/2/01
2 75-682 IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG BASF CORPORATION 11/14/01
3 75-347 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, 20 MG, AND 40 MG ANDRX PHARMACEUTICALS, INC. 11/16/01
4 65-034 DAUNORUBICIN HYDROCHLORIDE INJECTION 5 MG (BASE)/ML; 4 ML SINGLE-DOSE VIALS SUPERGEN, INC. 11/20/01
5 76-117 IBUPROFEN TABLETS, USP (OTC) 200 MG DR. REDDY'S LABORATORIES LIMITED 11/20/01
6 75-569 THALLOUS CHLORIDE TL-201 INJECTION, USP 1 mCi/ML MOUNT SINAI MEDICAL CENTER 11/21/01
7 75-749 DILTIAZEM HYDROCHLORIDE INJECTION 5 MG/ML, PACKAGED IN 25 MG/5 ML SYRINGE AND 50 MG/10 ML DILUTE-A-JET SYRINGE INTERNATIONAL MEDICATION SYSTEMS LIMITED 11/21/01
8 75-915 TIOCONAZOLE VAGINAL OINTMENT 6.5% (OTC) L. PERRIGO COMPANY 11/21/01
9 40-434 OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MG ENDO PHARMACEUTICALS, INC. 11/23/01
10 75-870 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML SINGLE-DOSE VIAL) ABBOTT LABORATORIES 11/23/01
11 75-905 FAMOTIDINE INJECTION 10 MG/ML; PACKAGED IN 4 ML & 20 ML MULTIPLE-DOSE VIALS ABBOTT LABORATORIES 11/23/01
12 75-794 ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS, USP 250 MG/250 MG/65 MG, RESPECTIVELY (OTC) L. PERRIGO COMPANY 11/26/01
13 76-057 ETHAMBUTOL HYDROCHLORIDE TABLETS, USP 400 MG BARR LABORATORIES, INC. 11/26/01
14 75-404 FAMOTIDINE TABLETS, USP (OTC) 10 MG DANBURY PHARMACAL, INC. 11/28/01
15 75-721 LEUPROLIDE ACETATE INJECTION 1 MG/0.2 ML (2.8 ML MULTIPLE-DOSE VIALS) GENZYME CORPORATION 11/29/01
16 75-998 PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG MUTUAL PHARMACEUTICAL COMPANY 11/29/01
17 75-231 BUTALBITAL, ASPIRIN, CAFFEINE, & CODEINE PHOSPHATE CAPS, USP 50 MG/325 MG/40 MG/30 MG ANABOLIC, INC. 11/30/01
18 75-829 ETODOLAC EXTENDED-RELEASE TABLETS 400 MG 500 MG ANDRX PHARMACEUTICALS, L.L.C. 11/30/01
19 75-840 NORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 21-DAY & 28-DAY REGIMENS; 0.3 MG/0.03 MG NOTE:28-DAY REGIMEN ALSO CONTAINS 7 INERT TABLETS. DURAMED PHARMACEUTICALS, INC. 11/30/01
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