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FDA Drug Application 022185 by LEO PHARMA AS

Application Number022185
Application Type New Drug Application
Sponsor ApplicantLEO PHARMA AS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/9/2008N22240000 4/14/2009
AP05/9/2008N19836000 5/15/2008
AP05/9/2008N20251000 7/17/2008
AP03/20/2009SCP22094003 3/24/2009
AP010/17/2012SE134124010 10/18/2012
AP010/17/2012SE134136010 10/22/2012
AP011/30/2012SLR34525012 12/4/2012
AP011/30/2012SLR34541012 12/4/2012
AP011/7/2013SCM37856015, s016lbl.pdf 11/19/2013
AP011/7/2013SCM37756015,s016ltr.pdf 11/8/2013
AP011/7/2013SLR37759016, s016lbl.pdf 11/8/2013
AP011/7/2013SLR37755016,s016ltr.pdf 11/8/2013
AP08/29/2014SE840368018 9/3/2014
AP08/29/2014SE840402018 9/3/2014
AP010/29/2015SCM44372019 11/4/2015
AP07/28/2014SLR40029020 7/29/2014
AP07/28/2014SLR40041020 7/29/2014
AP06/21/2016SCM46410024 6/23/2016

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