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FDA Drug Application 021856 by TAKEDA PHARMS USA

Application Number021856
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
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
AP02/13/2009N21857000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021856s000ltr.pdf 2/18/2009
AP02/13/2009N21891000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021856lbl.pdf 2/20/2009
AP02/13/2009N22215000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000TOC.cfm 4/7/2009
AP02/13/2009N22216000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_SumR.pdf 4/7/2009
AP01/28/2011SLR27697003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021856s003ltr.pdf 2/3/2011
AP01/28/2011SLR27741003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021856s003lbl.pdf 2/4/2011
AP011/1/2012SLR34218006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021856s006lbl.pdf 11/2/2012
AP011/1/2012SLR34271006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021856Orig1s006ltr.pdf 11/6/2012
AP012/12/2013SCM       
AP010/23/2014SCM       
AP02/12/2016SCM       




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