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FDA Drug Application 021001 by JANSSEN PHARMS

Application Number021001
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP05/7/2001N4606000 5/7/2001
AP05/7/2001N4607000 5/7/2001
AP05/7/2001N7094000 12/8/2003
AP05/7/2001N8352000 4/15/2004
AP06/1/2004SLR9088002 6/7/2004
AP03/27/2009SLR22143008,s009ltr.pdf 4/1/2009
AP03/27/2009SLR22176008 4/3/2009
AP03/27/2009SLR22177009 4/3/2009
AP03/27/2009SLR22144009,s009ltr.pdf 4/1/2009
AP04/30/2009SLR22444010,s011ltr.pdf 5/6/2009
AP04/30/2009SLR22487010 5/11/2009
AP04/30/2009SE522488011 5/11/2009
AP08/7/2014SLR40188014 8/8/2014
AP08/7/2014SLR40194014 8/11/2014

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