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FDA Drug Application 020954 by OTSUKA PHARM

Application Number020954
Application Type New Drug Application
Sponsor ApplicantOTSUKA PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/4/1999N706000 2/4/1999
AP02/4/1999N707000 6/14/1999
AP02/4/1999N708000 2/4/1999
AP012/23/2002SLR3803001 12/23/2002
AP012/23/2002SLR7838001 3/9/2004
AP04/24/2002SLR7839003 3/9/2004
AP04/24/2002SLR3806003 4/24/2002
AP01/13/2003SE29040004 6/4/2004
AP01/13/2003SE24209004 3/6/2003
AP01/13/2003SE24838004 1/13/2003
AP011/13/2002SCP6114005 7/8/2003
AP011/13/2002SCP3808005 11/13/2002
AP011/13/2002SCP3810005 11/13/2002
AP04/19/2007SCP16256008 4/20/2007
AP04/19/2007SCP16313008 4/25/2007
AP06/23/2011SLR29326009 6/29/2011
AP06/23/2011SLR29365009,s010ltr.pdf 6/29/2011
AP06/23/2011SLR29366010,s010ltr.pdf 6/29/2011
AP06/23/2011SLR29327010 6/29/2011
AP01/16/2015SLR41648014 1/20/2015
AP01/16/2015SLR41652014 1/20/2015
AP05/19/2016SLR46078016 5/20/2016
AP05/19/2016SLR46101016 5/23/2016

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