• 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 - December 2001

 ANDA NumberDrug NameApplicantApproval Date
175-427CROMOLYN SODIUM NASAL SOLUTION, USP (OTC) 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 13 ML & 26 ML METERED SPRAY BOTTLESL. PERRIGO COMPANY12/12/01
275-639FAMOTIDINE TABLETS, USP 20 MG AND 40 MGMUTUAL PHARMACEUTICAL COMPANY, INC.12/12/01
375-661IBUPROFEN TABLETS, USP (OTC) 200 MGBASF CORPORATION12/12/01
476-152DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MGMYLAN PHARMACEUTICALS, INC.12/13/01
575-300LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGGENEVA PHARMACEUTICALS, INC.12/17/01
675-451LOVASTATIN TABLETS, USP 10 MG, 20 MG AND 40 MGMYLAN PHARMACEUTICALS, INC.12/17/01
775-551LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGTEVA PHARMACEUTICALS USA12/17/01
875-636LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGEON LABS MANUFACTURING, INC.12/17/01
975-729FAMOTIDINE INJECTION 0.4 MG/MLABBOTT LABORATORIES12/17/01
1075-828LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGPUREPAC PHARMACEUTICAL CO.12/17/01
1175-935LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MGGENPHARM INC.12/17/01
1265-054CYCLOSPORINE ORAL SOLUTION USP (MODIFIED) 100 MG/MLSIDMAK LABORATORIES, INC.12/18/01
1375-927NAPROXEN TABLETS, USP 250 MG 375 MG 500 MGINTERPHARM, INC.12/18/01
1476-090PERMETHRIN LOTION 1%CLAY-PARK LABS., INC.12/20/01
1575-450METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 20 MGPUREPAC PHARMACEUTICAL CO.12/21/01
1675-674FAMOTIDINE TABLETS, USP (OTC) 10 MGGENPHARM INC.12/21/01
1776-092KETAMINE HYDROCHLORIDE INJECTION, USP 50 MG (BASE)/MLBIONICHE PHARMA (CANADA) LTD.12/28/01