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FDA Drug Application 204654 by APIL

Application Number204654
Application Type New Drug Application
Sponsor ApplicantAPIL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/24/2013N36616000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204654Orig1s000ltr.pdf 7/26/2013
AP07/24/2013N36660000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204654s000lbl.pdf 7/30/2013
AP07/24/2013N38694000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000TOC.cfm 3/6/2014
AP07/24/2013N38695000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204654Orig1s000SumR.pdf 3/6/2014
AP04/16/2014SCM       
AP05/20/2014SCM       
AP010/7/2014SCM       




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