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FDA Drug Application 021883 by DURATA THERAPS INTL

Application Number021883
Application Type New Drug Application
Sponsor ApplicantDURATA THERAPS INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/23/2014N39351000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021883Orig1s000ltr.pdf 5/27/2014
AP05/23/2014N39352000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf 5/27/2014
AP05/23/2014N39660000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000TOC.cfm 6/25/2014
AP05/23/2014N39661000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000SumR.pdf 6/25/2014
AP011/20/2014SCM       
AP012/18/2015SLR44834002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021883Orig1s002ltr.pdf 12/22/2015
AP01/20/2016SE844995003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021883Orig1s003ltr.pdf 1/21/2016
AP01/20/2016SE845028003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021883s003lbl.pdf 1/26/2016
AP08/18/2016SCM       




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