Back to FDA Applications sponsored by ASTELLAS

FDA Drug Application 207501 by ASTELLAS

Application Number207501
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
AP03/6/2015N42044000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207501Orig1s000ltr.pdf 3/6/2015
AP03/6/2015N42045000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207501Orig1s000lbl.pdf 3/6/2015
AP03/6/2015N42424000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000TOC.cfm 4/3/2015
AP03/6/2015N42425000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000Lbl.pdf 4/3/2015
AP04/3/2015SLR42431001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501Orig1s001ltr.pdf 4/6/2015
AP04/3/2015SLR42685001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf 4/28/2015
AP09/30/2016SCM       




Back to FDA Applications sponsored by ASTELLAS

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.