First-Time Generic Drug Approvals: March 2012

  • Fenofibrate Capsules 43 mg and 130 mg
    Approved: March 1, 2012 - Dr Reddy's Laboratories, S.A.
    Generic for: Antara
  • Ziprasidone Hydrochloride Tablets 20 mg (base), 40 mg (base), 60 mg (base) and 80 mg (base)
    Approved: March 2, 2012 - Lupin Pharmaceuticals, Inc.; Apotex Corp.; Dr. Reddy's Laboratories Limited
    Generic for: Geodon
  • Glycopyrrolate Tablets USP, 1.5 mg
    Approved: March 12, 2012 - Nexgen Pharma, Inc.
    Generic for: Robinul Forte
  • Escitalopram Oxalate Tablets 5 mg (base), 10 mg (base) and 20 mg (base)
    Approved: March 14, 2012 - Teva Pharmaceuticals, USA
    Generic for: Lexapro Tablets
  • Escitalopram Oxalate Oral Solution 5 mg (base)/5 mL
    Approved: March 14, 2012 - Amneal Pharmaceuticals LLC
    Generic for: Lexapro Oral Solution
  • Ibandronate Sodium Tablets 150 mg (base)
    Approved: March 19, 2012 - Apotex Inc.; Mylan Pharmaceuticals Inc.; Orchid Healthcare
    Generic for: Boniva
  • Quetiapine Fumarate Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), 200 mg (base), 300 mg (base) and 400 mg (base)
    Approved: March 27, 2012 - Dr. Reddy's Laboratories Limited; Teva Pharmaceuticals, USA; Roxane Laboratories, Inc.; Mylan Pharmaceuticals Inc.; Apotex Corp.; Aurobindo Pharma Limited; Torrent Pharmaceuticals Limited; Lupin Pharmaceuticals Inc.; Sun Pharmaceutical Industries; Accord Healthcare Inc.
    Generic for: Seroquel
  • Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25 mg
    Approved: March 30, 2012 - Teva Pharmaceuticals USA
    Generic for: Avalide
  • Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg
    Approved: March 30, 2012 - Teva Pharmaceuticals USA
    Generic for: Avapro
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