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FDA Drug Application 021348 by ACTELION PHARMS LTD

Application Number021348
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
AP07/31/2003N6499000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21348_zavesca_lbl.pdf 8/15/2003
AP07/31/2003N6521000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21348ltr.pdf 8/15/2003
AP07/31/2003N7244000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-348_Zavesca.cfm 12/15/2003
AP02/29/2008SLR19349005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021348s005ltr.pdf 3/4/2008
AP02/29/2008SLR19371005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021348s005lbl.pdf 3/5/2008
AP011/23/2010SLR27060008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021348s008ltr.pdf 11/29/2010
AP011/23/2010SLR27211008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021348s008lbl.pdf 11/23/2010
AP02/10/2014SLR38497010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021348Orig1s010ltr.pdf 2/11/2014
AP02/10/2014SLR38498010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021348s010lbl.pdf 2/11/2014
AP010/30/2014SCM       
AP01/15/2016SCM       




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