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FDA Drug Application 202971 by OTSUKA PHARM CO LTD

Application Number202971
Application Type New Drug Application
Sponsor ApplicantOTSUKA PHARM CO LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/28/2013N35296000 3/1/2013
AP02/28/2013N35354000 3/7/2013
AP02/28/2013N35472000 3/15/2013
AP02/28/2013N35683000 4/11/2013
AP02/28/2013N35684000 4/11/2013
AP05/30/2014SCM39434002 6/3/2014
AP012/5/2014SE841179003 12/9/2014
AP012/5/2014SE841203003 12/10/2014
AP012/5/2014SE843493003 7/27/2015
AP09/29/2014SCM40675004 9/30/2014
AP07/29/2015SE843528006 7/30/2015
AP07/29/2015SE843532006 7/30/2015
AP01/15/2016SLR44986008,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf 1/20/2016
AP01/15/2016SLR45006008 1/22/2016
AP08/18/2016SLR46818009,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf 8/19/2016
AP08/18/2016SLR46846009 8/23/2016

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