• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Tentative Approvals - July 2002

 ANDA NumberDrug NameApplicantTentative Approval Date
175-706LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS 10 MG/240 MG (24-HOUR FORMULATION)ANDRX PHARMACEUTICALS, LLC7/9/02
275-919MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1%ALTANA INC.7/10/02
376-171MOMETASONE FUROATE CREAM, USP 0.1%ALTANA INC.7/10/02
476-179TAMOXIFEN CITRATE TABLETS, USP 10 MG (BASE) AND 20 MG (BASE)ANDRX PHARMACEUTICALS, INC.7/10/02
576-217AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (PACKAGED IN 150 MG/3 ML VIALS)BIONICHE PHARMA (CANADA) LTD.7/10/02
676-088AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (PACKAGED IN 150 MG/3 ML SINGLE-USE VIALS); PRESERVATIVE-FREEBEN VENUE LABORATORIES, INC.7/17/02
776-173RILUZOLE TABLETS 50 MGIMPAX LABORATORIES, INC.7/17/02
875-711ALENDRONATE SODIUM TABLETS 5 MG, 10 MG, AND 40 MGIVAX PHARMACEUTICALS, INC.7/24/02
975-923OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 10 MG, 20 MG, 40 MG, AND 80 MGENDO PHARMACEUTICALS, INC.7/31/02