Back to FDA Applications sponsored by UNITED THERAP

FDA Drug Application 021272 by UNITED THERAP

Application Number021272
Application Type New Drug Application
Sponsor ApplicantUNITED THERAP
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
AP05/21/2002N3153000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21272ini.pdf 5/21/2002
AP05/21/2002N3154000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf 5/21/2002
AP05/21/2002N3155000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-272_Remodulin.cfm 7/31/2002
AP011/24/2004SE330829002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021272Orig1s002.pdf 10/10/2011
AP01/20/2006SLR13549003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272s003ltr.pdf 1/30/2006
AP03/20/2006SE713774005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf 3/22/2006
AP03/20/2006SE713792005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272S005ltr.pdf 3/23/2006
AP03/20/2006SE744513005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021272Orig1s005.pdf 11/18/2015
AP09/12/2008SLR20773008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf 9/16/2008
AP09/12/2008SLR20855008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf 9/19/2008
AP02/4/2008SLR19067009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s009ltr.pdf 2/7/2008
AP02/4/2008SLR19132009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf 2/14/2008
AP01/8/2010SLR24500011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf 1/12/2010
AP01/8/2010SLR24518011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021272s011ltr.pdf 1/15/2010
AP02/8/2011SLR27798015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf 2/9/2011
AP02/8/2011SLR27825015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021272s015ltr.pdf 2/14/2011
AP012/22/2014SLR41433019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021272Orig1s019ltr.pdf 12/30/2014
AP012/22/2014SLR47172019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf 9/27/2016
AP09/24/2013SLR37231020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf 9/26/2013
AP09/24/2013SLR37240020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf 9/27/2013
AP09/24/2013SLR37251020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf 9/27/2013
AP09/24/2013SLR37268020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf 10/1/2013
AP09/24/2013SLR38292020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf 1/16/2014
AP19/26/2013SLR37231020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf 9/26/2013
AP19/26/2013SLR37240020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf 9/27/2013
AP19/26/2013SLR37251020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf 9/27/2013
AP19/26/2013SLR37268020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf 10/1/2013
AP19/26/2013SLR38292020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf 1/16/2014
AP01/3/2014SCM       
AP01/22/2016SCM       




Back to FDA Applications sponsored by UNITED THERAP