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FDA Drug Application 021123 by JANSSEN PHARMS

Application Number021123
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/15/2001N1872000 8/15/2001
AP08/15/2001N5190000 8/15/2001
AP08/15/2001N5191000 8/15/2001
AP04/16/2004SLR8370001,21123slr001ltr.pdf 4/20/2004
AP04/16/2004SLR8472001,21123slr001_Ultram_lbl.pdf 5/3/2004
AP09/9/2009SLR23392003 9/17/2009
AP09/9/2009SLR23797003 11/10/2009
AP06/22/2011SLR29302005 6/28/2011
AP06/22/2011SLR29348005 6/29/2011
AP010/18/2013SLR37485008 10/21/2013
AP010/18/2013SLR37525008 10/22/2013

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