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FDA Drug Application 022198 by KYOWA KIRIN

Application Number022198
Application Type New Drug Application
Sponsor ApplicantKYOWA KIRIN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/12/2008N20778000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022198s000ltr.pdf 9/16/2008
AP09/12/2008N20867000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf 9/19/2008
AP09/12/2008N23468000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022198_sancuso_toc.cfm 9/30/2009
AP09/28/2015SLR44032003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf 9/29/2015
AP09/28/2015SLR44063003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022198Orig1s003ltr.pdf 10/1/2015
AP09/23/2011SLR30103005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022198s005ltr.pdf 9/28/2011
AP09/23/2011SLR30125005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf 9/29/2011
AP02/14/2013SCM       
AP011/19/2013SCM       
AP07/15/2014SCM       
AP09/18/2014SLR40532012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022198s012lbl.pdf 9/22/2014
AP09/18/2014SLR40561012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022198Orig1s012ltr.pdf 9/23/2014
AP09/21/2016SCM       




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