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FDA Drug Application 022275 by OTSUKA AMERICA PHARM

Application Number022275
Application Type New Drug Application
Sponsor ApplicantOTSUKA AMERICA PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/19/2009N22616000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022275lbl.pdf 5/25/2009
AP05/19/2009N22637000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022275s000ltr.pdf 5/27/2009
AP05/19/2009N23004000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000TOC.cfm 7/21/2009
AP05/19/2009N23005000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022275s000_SumR.pdf 7/21/2009
AP05/19/2009N27128000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235540.pdf 12/2/2010
AP05/19/2009N38188000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm350203.htm 12/27/2013
AP09/23/2011SLR30119003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022275s003ltr.pdf 9/28/2011
AP02/1/2012SLR31634005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s005lbl.pdf 2/2/2012
AP02/1/2012SLR31647005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275s005ltr.pdf 2/3/2012
AP011/16/2012SLR34426007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s007ltr.pdf 11/19/2012
AP011/16/2012SLR34430007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022275s007lbl.pdf 11/19/2012
AP09/14/2012SLR33772008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s008ltr.pdf 9/17/2012
AP04/9/2013SLR35724009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s009lbl.pdf 4/16/2013
AP04/9/2013SLR35747009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s009ltr.pdf 4/18/2013
AP09/27/2013SCM       
AP05/2/2013SLR35985011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s011ltr.pdf 5/8/2013
AP05/2/2013SLR36095011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022275s011lbl.pdf 5/21/2013
AP02/28/2014SLR38646014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022275s014lbl.pdf 3/4/2014
AP02/28/2014SLR38661014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022275Orig1s014ltr.pdf 3/5/2014




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