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FDA Drug Application 021779 by ACTELION PHARMS LTD

Application Number021779
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/2004N10918000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021779ltr.pdf 1/11/2005
AP012/29/2004N10942000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021779lbl.pdf 1/11/2005
AP012/29/2004N11290000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-779_Ventavis.cfm 3/28/2005
AP08/24/2005SE112670001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf 8/31/2005
AP08/24/2005SE112688001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf 8/31/2005
AP08/24/2005SCF12671002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf 8/31/2005
AP08/24/2005SCF12689002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf 8/31/2005
AP012/8/2005SCS13256003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s003lbl.pdf 12/15/2005
AP012/8/2005SCS13269003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s003ltr.pdf 12/15/2005
AP03/4/2008SLR19358006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s006lbl.pdf 3/5/2008
AP03/4/2008SLR19397006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s006ltr.pdf 3/7/2008
AP09/22/2008SLR20875008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s008ltr.pdf 9/23/2008
AP09/22/2008SLR20882008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s008lbl.pdf 9/25/2008
AP08/7/2009SCM23436009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf 9/22/2009
AP08/7/2009SCM24650009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021779s009ltr.pdf 1/27/2010
AP08/7/2009SCM30818009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021779Orig1s009.pdf 10/10/2011
AP04/20/2010SLR25338010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021779s010ltr.pdf 4/23/2010
AP04/20/2010SLR25436010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021779s010lbl.pdf 5/3/2010
AP02/8/2011SLR27801012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021779s012lbl.pdf 2/9/2011
AP02/8/2011SLR27827012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021779s012ltr.pdf 2/14/2011
AP04/26/2012SLR32574013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021779s013lbl.pdf 5/1/2012
AP04/26/2012SLR32584013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021779Orig1s013ltr.pdf 5/2/2012
AP011/22/2013SLR37906014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021779Orig1s014ltr_corrected.pdf 11/25/2013
AP011/22/2013SLR37933014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021779s014lbl.pdf 11/26/2013
AP011/10/2014SCM       
AP01/5/2015SCM       




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