Back to FDA Applications sponsored by BIOGEN IDEC INC

FDA Drug Application 125499 by BIOGEN IDEC INC

Application Number125499
Application Type Biologic License Application
Sponsor ApplicantBIOGEN IDEC INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/15/2014N40256000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125499s000ltredt.pdf 8/18/2014
AP08/15/2014N40257000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf 8/18/2014
AP08/15/2014N40503000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000TOC.cfm 9/17/2014
AP08/15/2014N40504000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000SumR.pdf 9/17/2014
AP08/15/2014N44663000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM475804.pdf 12/7/2015
AP012/22/2015S44871009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125499s009ltr.pdf 12/23/2015
AP012/22/2015S44890009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf 12/28/2015
AP07/14/2016SLR46534011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125499Orig1s011ltr.pdf 7/15/2016
AP07/14/2016SLR46545011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf 7/18/2016




Back to FDA Applications sponsored by BIOGEN IDEC INC