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FDA Drug Application 203479 by JAZZ PHARMS III

Application Number203479
Application Type New Drug Application
Sponsor ApplicantJAZZ PHARMS III
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
AP02/6/2013N35100000REMS 2/8/2013
AP02/6/2013N35107000 2/8/2013
AP02/6/2013N35108000 2/8/2013
AP02/6/2013N37181000 9/20/2013
AP02/6/2013N37182000 9/20/2013
AP012/5/2013SLR37988001 12/9/2013
AP012/5/2013SLR38258001 1/13/2014
AP08/22/2013SLR36881002 8/23/2013
AP08/22/2013SLR36888002 8/27/2013
AP09/15/2015SLR43902007,s008ltr.pdf 9/17/2015
AP09/15/2015SLR43893007 9/16/2015
AP09/15/2015S43894008 9/16/2015
AP09/15/2015S43903008,s008ltr.pdf 9/17/2015
AP09/30/2015SLR44099009,203479Orig1s009ltr.pdf 10/2/2015
AP09/30/2015SLR44735009,203479s009lbl.pdf 12/10/2015

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