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FDA Drug Application 017453 by TEVA BRANDED PHARM

Application Number017453
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       
AP06/23/1981SCP       
AP012/14/1982SLR       
AP012/4/1984SCE       
AP02/24/1987SCP       
AP05/14/1987SCM       
AP07/28/1989SLR       
AP01/21/2004SCM7577010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17453scm010ltr.pdf 1/22/2004
AP012/17/2008SCM21405014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017453s014ltr.pdf 12/24/2008
AP012/17/2008SCM21455014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017453s014lbl.pdf 1/2/2009
AP011/21/2013SCM       
AP09/18/2015SLR43924020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017425Orig1s016,017453s020ltr.pdf 9/21/2015
AP09/18/2015SLR43927020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017453s020lbl.pdf 9/21/2015
AP05/13/2016SCM       




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