First-Time Generic Drug Approvals: June 2007

  • Benzonatate Capsules USP, 100 mg and 200 mg
    Approved: June 8, 2007 - Zydus Pharmaceuticals USA, Inc.
    Generic for: Tessalon Capsules (Perles)
  • Cefepime for Injection USP, 500 mg/vial, 1 gram/vial and 2 grams/vial
    Approved: June 18, 2007 - Orchid Healthcare
    Generic for: Maxipime For Injection
  • Tretinoin Capsules 10 mg
    Approved: June 21, 2007 - Barr Laboratories, Inc.
    Generic for: Vesanoid Capsules, 10 mg
  • Paroxetine Hydrochloride Extended-Release Tablets, 12.5 mg (base) and 25 mg (base)
    Approved: June 29, 2007 - Mylan Pharmaceuticals, Inc.
    Generic for: Paxil CR Extended-Release Tablets

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