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FDA Drug Application 203415 by ASTELLAS

Application Number203415
Application Type New Drug Application
Sponsor ApplicantASTELLAS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/31/2012N33607000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf 8/31/2012
AP08/31/2012N33641000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203415Orig1s000ltr.pdf 9/5/2012
AP08/31/2012N33737000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415_xtandi_toc.cfm 9/12/2012
AP08/31/2012N33738000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203415Orig1s000SumR.pdf 9/12/2012
AP03/19/2013SCM35540001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203415s001lbl.pdf 3/26/2013
AP05/23/2014SCM       
AP09/10/2014SE840472003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf 9/10/2014
AP09/10/2014SE840480003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203415Orig1s003ltr.pdf 9/16/2014
AP07/21/2015SE843431005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s005ltr.pdf 7/22/2015
AP07/21/2015SE843451005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s005lbl.pdf 7/22/2015
AP08/5/2015SLR43599006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s006ltr.pdf 8/10/2015
AP08/5/2015SLR43931006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s006lbl.pdf 9/21/2015
AP010/1/2015SLR44169007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203415s007lbl.pdf 10/8/2015
AP010/1/2015SLR44185007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203415Orig1s007ltr.pdf 10/9/2015
AP011/6/2015SCM       
AP010/20/2016SE847425009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203415Orig1s009ltr.pdf 10/21/2016
AP010/20/2016SE847429009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203415s009lbl.pdf 10/21/2016
AP07/14/2016SCM       




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