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First-Time Generic Drug Approvals: January 2014

  • Lamivudine Tablets (HBV) 100 mg
    Approved: January 2, 2014 - Hetero Labs Limited; Apotex Corp.
    Generic for: Epivir-HBV
  • Telmisartan Tablets 20 mg, 40 mg and 80 mg
    Approved: January 8, 2014 - Watson Laboratories, Inc.
    Generic for: Micardis
  • Amlodipine Besylate and Telmisartan Tablets 5 mg (base)/40 mg, 10 mg (base)/40 mg, 5 mg (base)/80 mg and 10 mg (base)/80 mg
    Approved: January 8, 2014 - Lupin Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Inc.
    Generic for: Twynsta
  • Sirolimus Tablets 0.5 mg, 1 mg and 2 mg
    Approved: January 8, 2014 - Zydus Pharmaceuticals (USA) Inc.
    Generic for: Rapamune
  • Mycophenolic Acid Delayed-Release Tablets 180 mg and 360 mg
    Approved: January 8, 2014 - Mylan Pharmaceuticals, Inc.
    Generic for: Myfortic
  • Doxercalciferol Capsules 1 mcg and 2.5 mcg
    Approved: January 14, 2014 - Roxane Laboratories, Inc.
    Generic for: Hectorol
  • Fluocinonide Cream USP, 0.1%
    Approved: January 14, 2014 - Perrigo Israel Pharmaceuticals, Ltd.
    Generic for: Vanos
  • Bromfenac Ophthalmic Solution 0.09% (Once-A-Day)
    Approved: January 22, 2014 - Hi-Tech Pharmacal Co., Inc.
    Generic for: Bromday
  • Sunitinib Malate Capsules 12.5 mg (base), 25 mg (base), 37.5 mg (base) and 50 mg (base)
    Approved: January 30, 2014 - Mylan Pharmaceuticals Inc.
    Generic for: Sutent

Generic Approvals Archive