• 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 - July 2001

 ANDA NumberDrug NameApplicantApproval Date
175-702CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 26 ML BOTTLE.BAUSCH & LOMB PHARMACEUTICALS, INC.7/3/01
275-712CARBAMAZEPINE TABLETS, USP (CHEWABLE) 100 MGCARACO PHARMACEUTICAL LABORATORIES, LTD.7/5/01
340-407PROCHLORPERAZINE SUPPOSITORIES, USP 2.5 MG, 5 MG, AND 25 MGABLE LABORATORIES, INC.7/11/01
475-735PENTAZOCINE AND NALOXONE HCL TABLETS, USP 50 MG (BASE)/0.5 MG (BASE)AMIDE PHARMACEUTICAL, INC.7/11/01
575-838PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG (WHITE TABLETS AND PINK TABLETS)ABLE LABORATORIES, INC.7/11/01
675-809LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP TRIPHASIC REGIMEN 0.05 MG/0.03 MG, 0.075 MG/0.04 MG, AND 0.125 MG/0.03 MG; 21-DAY AND 28-DAY CYCLES.DURAMED PHARMACEUTICALS, INC.7/16/01
740-390BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/325 MG/40 MGABLE LABORATORIES, INC.7/23/01
840-394BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/500 MG/40 MGABLE LABORATORIES, INC.7/23/01
975-278PACLITAXEL INJECTION 6 MG/ML; PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML AND 300 MG/50 ML MULTIPLE-DOSE VIALS.MYLAN PHARMACEUTICALS, INC.7/23/01
1075-611FAMOTIDINE TABLETS, USP 20 MG AND 40 MGTORPHARM7/23/01
1175-626KETOROLAC TROMETHAMINE INJECTION, USP 30 MG/ML (MULTIPLE-DOSE VIALS)APOTEX CORP.7/24/01
1275-671MEGESTROL ACETATE ORAL SUSPENSION 40 MG/MLPAR PHARMACEUTICAL, INC.7/25/01
1374-800CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 13 ML & 26 ML BOTTLESALPHARMA, U.S. PHARMACEUTICALS DIVISION7/26/01
1475-512FAMOTIDINE TABLETS, USP (OTC) 10 MGIVAX PHARMACEUTICALS, INC.7/26/01
1575-993LACTULOSE SOLUTION, USP 10 G/15 MLVINTAGE PHARMACEUTICALS, INC.7/26/01
1665-081CEPHALEXIN FOR ORAL SUSPENSION, USP 125 MG/5 ML AND 250 MG/5 MLRANBAXY LABORATORIES LIMITED7/27/01
1775-190PACLITAXEL INJECTION 6 MG/ML; PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS.BEDFORD LABORATORIES7/27/01
1875-085HYDROCORTISONE VALERATE OINTMENT, USP 0.2%ALTANA INC.7/31/01
1975-442FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MGALPHAPHARM PTY. LTD.7/31/01