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FDA Drug Application 022195 by ROXANE

Application Number022195
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/17/2008N19485000, 022207s000ltr.pdf 3/19/2008
AP03/17/2008N19515000,022207lbl.pdf 3/24/2008
AP03/17/2008N22149000 4/1/2009
AP03/17/2008N22150000 4/1/2009
AP03/17/2008N34115000 10/17/2012
AP01/25/2010SE224669002 1/29/2010
AP01/25/2010SE224670002 1/29/2010
AP01/25/2010SE224681002 1/29/2010
AP010/18/2011SLR30355005 10/20/2011
AP01/23/2012SLR31495006 1/23/2012
AP01/23/2012SLR31514006 1/25/2012
AP04/21/2015SCM42627007 4/22/2015
AP04/21/2015SCM42641007 4/23/2015
AP01/9/2014SLR38261009 1/14/2014

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