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FDA Drug Application 207500 by ASTELLAS

Application Number207500
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/6/2015N42043000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s000ltr.pdf 3/6/2015
AP03/6/2015N42046000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500Orig1s000lbl.pdf 3/6/2015
AP03/6/2015N42423000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000TOC.cfm 4/3/2015
AP03/6/2015N42426000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000Lbl.pdf 4/3/2015
AP04/3/2015SLR42430001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501Orig1s001ltr.pdf 4/6/2015
AP04/3/2015SLR42686001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf 4/28/2015
AP01/5/2016SCM       
AP08/12/2016SCM       




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