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FDA Drug Application 208079 by PROMIUS PHARMA LLC

Application Number208079
Application Type New Drug Application
Sponsor ApplicantPROMIUS PHARMA LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/5/2016N45131000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208079Orig1s000ltr.pdf 2/9/2016
AP02/5/2016N45139000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208079s000lbl.pdf 2/9/2016




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