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FDA Drug Application 206426 by BIOCRYST

Application Number206426
Application Type New Drug Application
Sponsor ApplicantBIOCRYST
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
AP012/19/2014N41374000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206426Orig1s000ltr.pdf 12/23/2014
AP012/19/2014N41545000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf 1/8/2015
AP012/19/2014N41634000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000TOC.cfm 1/16/2015
AP012/19/2014N41635000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000SumR.pdf 1/16/2015
AP03/11/2016SCM       
AP08/12/2016SLR46780003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206426Orig1s003ltr.pdf 8/15/2016
AP08/12/2016SLR46786003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206426s003lbl.pdf 8/17/2016




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