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FDA Drug Application 022260 by ACTELION PHARMS LTD

Application Number022260
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
AP06/27/2008N20146000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022260s000ltr.pdf 7/1/2008
AP06/27/2008N21141000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260_epoprostenol_toc.cfm 11/6/2008
AP06/27/2008N21142000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022260s000_SumR.pdf 11/6/2008
AP08/23/2010SLR26311002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022260s002ltr.pdf 8/30/2010
AP08/23/2010SLR26415002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022260s002lbl.pdf 9/7/2010
AP03/30/2011SLR28416004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022260s004ltr.pdf 4/1/2011
AP03/30/2011SLR28431004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022260s004lbl.pdf 4/1/2011
AP06/28/2012SCM36229005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf 6/5/2013
AP03/3/2015SCM       
AP07/18/2016SCM       




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