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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   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202971Orig1s000ltr.pdf 3/1/2013
AP02/28/2013N35354000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342207.pdf 3/7/2013
AP02/28/2013N35472000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202971s000lbl.pdf 3/15/2013
AP02/28/2013N35683000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202971s000TOC.cfm 4/11/2013
AP02/28/2013N35684000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202971Orig1s000SumR.pdf 4/11/2013
AP08/15/2014SCM       
AP05/30/2014SCM39434002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s002lbl.pdf 6/3/2014
AP012/5/2014SE841179003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202971Orig1s003ltr.pdf 12/9/2014
AP012/5/2014SE841203003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s003lbl.pdf 12/10/2014
AP012/5/2014SE843493003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202971Orig1s003TOC.cfm 7/27/2015
AP09/29/2014SCM40675004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202971s004lbl.pdf 9/30/2014
AP01/5/2015SCM       
AP07/29/2015SE843528006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202971Orig1s006ltr.pdf 7/30/2015
AP07/29/2015SE843532006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202971s006lbl.pdf 7/30/2015
AP03/24/2016SCM       
AP01/15/2016SLR44986008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf 1/20/2016
AP01/15/2016SLR45006008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s008lbl.pdf 1/22/2016
AP08/18/2016SLR46818009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf 8/19/2016
AP08/18/2016SLR46846009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202971s009lbl.pdf 8/23/2016




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