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FDA Drug Application 203568 by KASTLE THERAPS LLC

Application Number203568
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
AP01/29/2013N35012000REMS 1/30/2013
AP01/29/2013N35020000 1/30/2013
AP01/29/2013N35021000 1/31/2013
AP01/29/2013N35069000 2/5/2013
AP01/29/2013N35269000 2/27/2013
AP01/29/2013N35270000 2/27/2013
AP05/7/2014S39262002 5/9/2014
AP02/26/2015SLR41941004 2/27/2015
AP02/26/2015SLR41992004 3/3/2015
AP07/28/2015S43515005 7/29/2015
AP05/20/2016SLR46145008 5/25/2016
AP05/20/2016SLR46153008 5/25/2016

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