• 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 2001

 ANDA NumberDrug NameApplicantApproval Date
174-803FLUOXETINE CAPSULES, USP 20 MGBARR LABORATORIES, INC.8/2/01
275-049FLUOXETINE CAPSULES, USP 10 MGGENEVA PHARMACEUTICALS, INC.8/2/01
375-465FLUOXETINE CAPSULES, USP 40 MGDR. REDDY'S LABORATORIES LIMITED8/2/01
475-506FLUOXETINE ORAL SOLUTION, USP 20 MG/5 MLTEVA PHARMACEUTICALS, USA8/2/01
575-755FLUOXETINE HYDROCHLORIDE TABLETS 10 MG, AND 20 MGALPHAPHARM PTY. LTD.8/2/01
675-720METIPRANOLOL OPHTHALMIC SOLUTION 0.3%FALCON PHARMACEUTICALS, LTD.8/6/01
775-759BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML (1 MG/SPRAY); 2.5 ML METERED-DOSE SPRAY PUMPESI LEDERLE8/8/01
865-013TOBRAMYCIN FOR INJECTION, USP 1.2 G PHARMACY BULK PACKAGEPHARMA-TEK INC.8/17/01
975-758FAMOTIDINE TABLETS, USP (OTC) 10 MGDR. REDDY'S LABORATORIES LIMITED8/17/01
1075-851OXAPROZIN TABLETS 600 MGMYLAN PHARMACEUTICALS, INC.8/17/01
1175-918FLUPHENAZINE DECANOATE INJECTION, USP 25 MG/MLAPOTEX CORP.8/17/01
1240-424SPIRONOLACTONE TABLETS, USP 25 MG, 50 MG, AND 100 MGMYLAN PHARMACEUTICALS, INC.8/20/01
1374-911BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50MG/325MG/40MG/30MGAMARIN PHARMACEUTICALS, INC.8/22/01
1475-733CLOBETASOL PROPIONATE CREAM, USP (EMOLLIENT) 0.05%STIEFEL LABORATORIES, INC.8/22/01
1540-362PREDNISONE TABLETS, USP 5 MG, AND 10 MGTRIGEN LABORATORIES, INC.8/29/01
1676-035HALOPERIDOL INJECTION, USP 5 MG (BASE)/ML; 1 ML SINGLE-DOSE VIALS AND 10 ML MULTIPLE-DOSE VIALSGENSIA SICOR PHARMACEUTICALS, INC.8/29/01
1776-045LORAZEPAM TABLETS, USP 0.5 MG, 1 MG, AND 2 MGRANBAXY LABORATORIES LIMITED8/29/01
1840-402PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MGABLE LABORATORIES, INC.8/30/01
1940-403PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG (YELLOW)ABLE LABORATORIES, INC.8/30/01
2040-427PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG (BLUE/CLEAR)ABLE LABORATORIES, INC.8/30/01
2175-826PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 MG/ML (1 ML VIAL)AMERICAN PHARMACEUTICAL PARTNERS, INC.8/31/01