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FDA Drug Application 202317 by ACTELION PHARMS LTD

Application Number202317
Application Type New Drug Application
Sponsor ApplicantACTELION PHARMS LTD
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
AP08/23/2013N36896000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf 8/27/2013
AP08/23/2013N36906000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202317Orig1s000ltr.pdf 8/27/2013
AP08/23/2013N36926000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366908.pdf 8/30/2013
AP08/23/2013N38798000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000TOC.cfm 3/14/2014
AP08/23/2013N38799000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202317Orig1s000SumR.pdf 3/14/2014
AP07/8/2014SLR       
AP07/8/2014SCM       
AP010/13/2014SCM       
AP010/29/2015SLR44350004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202317Orig1s004ltr.pdf 11/3/2015
AP010/29/2015SLR44366004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202317s004lbl.pdf 11/4/2015
AP04/8/2016SCM       




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