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FDA Drug Application 204410 by ACTELION PHARMS LTD

Application Number204410
Application Type New Drug Application
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
AP010/18/2013N37495000 10/22/2013
AP010/18/2013N37520000 10/22/2013
AP010/18/2013N37547000 10/24/2013
AP010/18/2013N37663000REMS 11/1/2013
AP010/18/2013N37845000 11/18/2013
AP010/18/2013N37846000 11/18/2013
AP011/17/2015SLR44520002 11/19/2015
AP011/17/2015SLR44532002 11/19/2015
AP04/30/2015SLR42711003 5/4/2015
AP04/30/2015SLR42726003 5/4/2015
AP02/17/2016SLR45195006 2/18/2016
AP02/17/2016SLR45206006 2/19/2016
AP02/22/2016S45250007 2/24/2016
AP06/15/2016SLR46370008 6/21/2016
AP06/15/2016SLR46374008 6/21/2016
AP010/21/2016SLR47432009 10/25/2016

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