Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail
-

Approvals - August 2002

 

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-452 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MG ABLE LABORATORIES, INC. 8/1/02
2 40-459 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/60 MG ABLE LABORATORIES, INC. 8/1/02
3 76-233 PACLITAXEL INJECTION 6 MG/ML (PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, 150 MG/25 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS) NAPRO BIOTHERAPEUTICS, INC. 8/1/02
4 75-942 FAMOTIDINE INJECTION 10 MG/ML (PACKAGED IN 40 MG/4 ML AND 200 MG/20 ML MULTIPLE-DOSE VIALS) APOTEX CORP. 8/2/02
5 76-002 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% ALPHARMA 8/2/02
6 76-013 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALS INTERNATIONAL MEDICATION SYSTEMS, LTD. 8/2/02
7 76-202 PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 25 MG (BASE)/650 MG AMIDE PHARMACEUTICAL, INC. 8/2/02
8 40-446 MEPERIDINE HYDROCHLORIDE TABLETS, USP 50 MG AND 100 MG CARACO PHARMACEUTICAL LABORATORIES LTD. 8/8/02
9 76-259 MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML ESI LEDERLE 8/8/02
10 76-070 NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG BIOVAIL LABORATORIES, INC. 8/16/02
11 40-454 PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML AND 50 MG/ML GENSIA SICOR PHARMACEUTICALS, INC. 8/22/02
12 76-021 TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) RANBAXY LABORATORIES LIMITED 8/22/02
13 75-514 FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 ML MORTON GROVE PHARMACEUTICALS, INC. 8/29/02
14 65-079 PENICILLIN G POTASSIUM FOR INJECTION, USP 1 MILLION UNITS/VIAL, 5 MILLION UNITS/VIAL, AND 20 MILLION UNITS/VIAL. BIOCHEMIE GmbH 8/30/02
15 75-478 NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.5 MG/0.035 MG; 0.75 MG/0.035 MG; AND 1 MG/0.035 MG PACKAGED IN 21-DAY AND 28-DAY REGIMENS BARR LABORATORIES, INC. 8/30/02
16 76-029 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE CHEWABLE TABLETS 2 MG/125 MG L. PERRIGO COMPANY 8/30/02
17 76-132 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG IMPAX LABORATORIES, INC. 8/30/02
18 76-195 RANITIDINE TABLETS, USP (OTC) 75 MG (BASE) L. PERRIGO COMPANY 8/30/02
-
-