First-Time Generic Drug Approvals: February 2012

  • Cisatracurium Besylate Injection 2 mg (base)/mL; packaged in 20 mg (base)/10 mL multiple-dose vials
    Approved: February 3, 2012 - Sandoz Inc.
    Generic for: Nimbex Injection
  • Cisatracurium Besylate Injection (Preservative Free) 10 mg (base)/mL packaged in 200 mg (base)/20 mL; and 2 mg (base)/mL packaged in 100 mg (base)/5 mL single-dose vials
    Approved: February 3, 2012 - Sandoz Inc.
    Generic for: Nimbex Injection
  • Tizanidine Hydrochloride Capsules 2 mg (base), 4 mg (base) and 6 mg (base)
    Approved: February 3, 2012 - Apotex Inc.
    Generic for: Zanaflex Capsules
  • Doxycycline Hyclate Delayed-Release Tablets USP, 150 mg (base)
    Approved: February 8, 2012 - Mylan Pharmaceuticals Inc.
    Generic for: Doryx Delayed-Release Tablets
  • Progesterone Capsules 100 mg and 200 mg
    Approved: February 29, 2012 - Teva Pharmaceuticals USA
    Generic for: Prometrium Capsules
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