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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - February 2012


  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 CISATRACURIUM BESYLATE INJECTION, 2 MG (BASE)/ML; PACKAGED IN 20 MG (BASE)/10 ML MULTIPLE-DOSE VIALS      SANDOZ INC. NIMBEX INJECTION

2/3/2012 

2 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     SANDOZ INC. NIMBEX INJECTION 2/3/2012 
3 TIZANIDINE HYDROCHLORIDE CAPSULES, 2 MG (BASE), 4 MG (BASE) AND 6 MG (BASE)  APOTEX INC. ZANAFLEX CAPSULES 2/3/2012 
4 DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS USP, 150 MG (BASE)        MYLAN PHARMACEUTICALS INC. DORYX DELAYED-RELEASE TABLETS 2/8/2012 
5 PROGESTERONE CAPSULES, 100 MG AND 200 MG       TEVA PHARMACEUTICALS USA PROMETRIUM CAPSULES 2/29/2012