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First-Time Generic Drug Approvals: April 2016

  • Rosiglitazone Maleate and Glimeperide Tablets 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg and 8 mg/8 mg
    Approved: April 1, 2016 - Teva Pharmaceuticals USA, Inc.
    Generic for: Avandaryl
  • Flurandrenolide Cream USP, 0.05%
    Approved: April 13, 2016 - Teligent Pharma, Inc.
    Generic for: Cordran SP Cream
  • Fosamprenavir Calcium Tablets 700 mg
    Approved: April 15, 2016 - Mylan Pharmaceuticals, Inc.
    Generic for: Lexiva Tablets
  • Lacosamide Oral Solution 10 mg/mL
    Approved: April 28, 2016 - Amneal Pharmaceuticals
    Generic for: Vimpat Oral Solution
  • Lacosamide Tablets 50 mg, 100 mg, 150 mg and 200 mg
    Approved: April 28, 2016 - Actavis Pharma, Inc.; MSN Laboratories; Alembic Pharmaceuticals Limited; Aurobindo Pharma Limited; Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
    Generic for: Vimpat
  • Rosuvastatin Calcium Tablets 5 mg, 10 mg, 20 mg and 40 mg
    Approved: April 29, 2016 - Watson Pharmaceuticals Inc.
    Generic for: Crestor

Generic Approvals Archive