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FDA Drug Application 021332 by ASTRAZENECA AB

Application Number021332
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA AB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/16/2005N11265000 3/18/2005
AP03/16/2005N11266000 3/18/2005
AP03/16/2005N11792000 6/14/2005
AP03/16/2005N15922000 2/28/2007
AP03/16/2005N43257000REMS 7/7/2015
AP09/25/2007SCP18032006 9/26/2007
AP09/25/2007SCP18158006 10/4/2007
AP06/27/2014SE839702007,s016ltr.pdf 6/30/2014
AP06/27/2014SE839721007 7/1/2014
AP08/4/2008SLR20511010 8/6/2008
AP06/27/2014SLR39722016 7/1/2014
AP06/27/2014SLR39701016,s016ltr.pdf 6/30/2014
AP01/3/2012SLR31339020 1/5/2012
AP02/25/2015SLR41933023 2/27/2015
AP02/25/2015SLR42005023 3/3/2015
AP08/7/2015S43616024 8/11/2015
AP03/20/2015SLR42252025 3/24/2015
AP03/20/2015SLR42514025 4/13/2015

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