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FDA Drug Application 204886 by ARALEZ PHARMS

Application Number204886
Application Type New Drug Application
Sponsor ApplicantARALEZ PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/8/2014N39264000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204886Orig1s000ltr.pdf 5/9/2014
AP05/8/2014N39270000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204886s000lbl.pdf 5/12/2014
AP05/8/2014N39582000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204886Orig1s000TOC.cfm 6/18/2014
AP05/8/2014N39583000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204886Orig1s000SumR.pdf 6/18/2014
AP07/14/2015SCM       
AP04/16/2015SLR42554002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204886Orig1s002ltr.pdf 4/17/2015
AP04/16/2015SLR42560002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204886s002lbl.pdf 4/17/2015
AP04/16/2015SLR42900002   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf 5/27/2015




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