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FDA Drug Application 022556 by TRIS PHARMA INC

Application Number022556
Application Type New Drug Application
Sponsor ApplicantTRIS PHARMA INC
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
AP03/28/2013N35584000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022556Orig1s000ltr.pdf 4/1/2013
AP03/28/2013N35614000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf 4/1/2013
AP03/28/2013N39656000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000TOC.cfm 6/24/2014
AP03/28/2013N39657000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000SumR.pdf 6/24/2014
AP09/10/2015SCM       
AP012/2/2015SCM       
AP05/12/2016SCM       




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