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FDA Drug Application 021290 by ACTELION PHARMS LTD

Application Number021290
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
AP011/20/2001N3998000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer_Approv.pdf 11/20/2001
AP011/20/2001N3999000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf 11/20/2001
AP011/20/2001N5186000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-290_Tracleer.cfm 11/20/2001
AP011/20/2001N5587000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089801.pdf 5/7/2003
AP011/20/2001N35061000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=61 2/4/2013
AP010/6/2003SE86764001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21290se8-001ltr.pdf 10/6/2003
AP010/6/2003SE86785001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8-001_tracleer_lbl.pdf 10/10/2003
AP010/6/2003SE87245001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-290S001_Tracleer.cfm 12/15/2003
AP011/24/2004SLR10675004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21290s004ltr.pdf 12/2/2004
AP011/29/2005SE813205006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf 12/5/2005
AP011/29/2005SE813220006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf 12/6/2005
AP011/29/2005SLR13206007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf 12/5/2005
AP011/29/2005SLR13221007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021290s006,007ltr.pdf 12/6/2005
AP02/15/2007SE815866010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf 2/21/2007
AP02/15/2007SE815889010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s010ltr.pdf 2/23/2007
AP06/1/2007SLR16665011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021290s011ltr.pdf 6/4/2007
AP08/7/2009SE123156012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012lbl.pdf 8/11/2009
AP08/7/2009SE123157012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s012SUMR.pdf 8/11/2009
AP08/7/2009SE123165012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s012ltr.pdf 8/13/2009
AP02/13/2009SLR21856014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s014ltr.pdf 2/18/2009
AP02/13/2009SLR21888014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf 2/20/2009
AP03/17/2009SLR22064015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf 3/20/2009
AP03/17/2009SLR22085015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s015ltr.pdf 3/24/2009
AP08/7/2009SLR23205016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021290s016ltr.pdf 8/20/2009
AP08/7/2009SLR23396016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf 9/17/2009
AP02/19/2010SLR24848018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021290s018ltr.pdf 2/25/2010
AP02/19/2010SLR24963018REMS  http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021290s018REMS.pdf 3/5/2010
AP02/8/2011SLR27800019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021290s019lbl.pdf 2/9/2011
AP02/8/2011SLR27826019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021290s019ltr.pdf 2/14/2011
AP010/4/2012SE833991022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022mg.pdf 10/5/2012
AP010/4/2012SE833992022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021290s022lbl.pdf 10/5/2012
AP010/4/2012SE833998022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021290Orig1s022ltr.pdf 10/9/2012
AP06/3/2013SCM       
AP07/1/2013SLR36440025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf 7/3/2013
AP07/1/2013SLR36458025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021290Orig1s025ltr.pdf 7/5/2013
AP012/4/2015S44701027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s027s029lbl.pdf 12/8/2015
AP012/4/2015S44711027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf 12/9/2015
AP012/4/2015SLR44675029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf 12/8/2015
AP012/4/2015SLR44712029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021290Orig1s027,s029ltr.pdf 12/9/2015
AP010/7/2016SCM       
AP010/20/2016SLR47427033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021290Orig1s033ltr.pdf 10/21/2016
AP010/20/2016SLR47428033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021290s033lbl.pdf 10/21/2016




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