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FDA Drug Application 204410 by ACTELION PHARMS LTD

Application Number204410
Application Type New Drug Application
Sponsor ApplicantACTELION PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/18/2013N37495000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204410Orig1s000ltr.pdf 10/22/2013
AP010/18/2013N37520000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204410s000lbl.pdf 10/22/2013
AP010/18/2013N37547000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372060.pdf 10/24/2013
AP010/18/2013N37663000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=76 11/1/2013
AP010/18/2013N37845000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000TOC.cfm 11/18/2013
AP010/18/2013N37846000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000SumR.pdf 11/18/2013
AP05/20/2014SCM       
AP011/17/2015SLR44520002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s002ltr.pdf 11/19/2015
AP011/17/2015SLR44532002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s002lbl.pdf 11/19/2015
AP04/30/2015SLR42711003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s003ltr.pdf 5/4/2015
AP04/30/2015SLR42726003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s003lbl.pdf 5/4/2015
AP03/22/2016SCM       
AP02/17/2016SLR45195006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s006lbl.pdf 2/18/2016
AP02/17/2016SLR45206006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s006ltr.pdf 2/19/2016
AP02/22/2016S45250007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s007ltr.pdf 2/24/2016
AP06/15/2016SLR46370008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s008ltr.pdf 6/21/2016
AP06/15/2016SLR46374008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s008lbl.pdf 6/21/2016
AP010/21/2016SLR47432009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s009ltr.pdf 10/25/2016




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