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FDA Drug Application 125166 by ALEXION PHARM

Application Number125166
Application Type Biologic License Application
Sponsor ApplicantALEXION PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/16/2007N160630000 3/23/2007
AP03/16/2007N161020000 3/27/2007
AP03/16/2007N165790000 5/17/2007
AP03/16/2007N167610000 6/14/2007
AP03/16/2007N258780000REMS 6/30/2010
AP06/30/2008S231440033 8/7/2009
AP06/4/2010S25852044 6/29/2010
AP09/23/2011S30067172 9/23/2011
AP09/23/2011S43420172 7/20/2015
AP012/21/2012SLR34776273 12/27/2012
AP04/30/2014SE839192368,125166Orig1s380ltr.pdf 5/2/2014
AP04/30/2014SE839199368 5/2/2014
AP04/30/2014SLR39200380 5/2/2014
AP04/30/2014SLR39193380,125166Orig1s380ltr.pdf 5/2/2014
AP010/10/2014S40761409 10/14/2014
AP012/3/2015SLR44679412,s413ltr.pdf 12/8/2015
AP012/3/2015S44680413,s413ltr.pdf 12/8/2015
AP012/3/2015S44699413 12/8/2015
AP04/13/2016S45688414 4/15/2016

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