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FDA Drug Application 021790 by OTSUKA PHARM CO LTD

Application Number021790
Application Type New Drug Application
Sponsor ApplicantOTSUKA PHARM CO LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/2/2006N14051000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021790lbl.pdf 5/4/2006
AP05/2/2006N14059000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021790s000LTR.pdf 5/5/2006
AP05/2/2006N14315000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021790s000_DacogenTOC.cfm 6/16/2006
AP03/11/2010SE225056006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021790s006lbl.pdf 3/18/2010
AP03/11/2010SE225063006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021790s006ltr.pdf 3/18/2010
AP05/6/2013SCM       
AP01/15/2014SCM       
AP04/7/2015SCM43800018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021790s018lbl.pdf 9/4/2015
AP03/8/2016SCM       




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