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FDA Drug Application 017425 by TEVA BRANDED PHARM

Application Number017425
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/28/1976N       
AP09/7/1979SLR       
AP07/9/1980SCF       
AP07/9/1980SCS       
AP012/14/1982SLR       
AP05/2/1983SCS       
AP06/28/1985SCP       
AP011/20/1986SCS       
AP05/14/1987SCM       
AP09/6/1988SCS       
AP07/28/1989SLR       
AP06/30/1994SCM       
AP01/24/1996SCS       
AP01/17/1997SCM       
AP09/18/2015SLR43926016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017425Orig1s016,017453s020ltr.pdf 9/21/2015
AP09/18/2015SLR43928016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017425s016lbl.pdf 9/21/2015




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