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FDA Drug Application 205718 by HELSINN HLTHCARE

Application Number205718
Application Type New Drug Application
Sponsor ApplicantHELSINN HLTHCARE
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
AP010/10/2014N40748000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205718Orig1s000ltr.pdf 10/10/2014
AP010/10/2014N40770000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf 10/14/2014
AP010/10/2014N40969000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000TOC.cfm 11/7/2014
AP010/10/2014N40970000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000SumR.pdf 11/7/2014
AP02/16/2015SCM       
AP04/29/2015SLR42739002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf 5/6/2015
AP04/27/2015SLR42694003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf 4/29/2015
AP04/27/2015SLR42731003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s003lbl.pdf 5/4/2015
AP05/13/2015SLR       
AP07/20/2015SCM       
AP04/12/2016SCM       
AP09/23/2016SCM       




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