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FDA Drug Application 204063 by BIOGEN IDEC INC

Application Number204063
Application Type New Drug Application
Sponsor ApplicantBIOGEN IDEC INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/27/2013N35565000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf 3/29/2013
AP03/27/2013N35577000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf 3/29/2013
AP03/27/2013N35850000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000TOC.cfm 4/25/2013
AP03/27/2013N35851000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000SumR.pdf 4/25/2013
AP03/27/2013N41379000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm424806.htm 12/23/2014
AP08/20/2013SCM       
AP012/3/2014SE841158003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf 12/4/2014
AP012/3/2014SE841191003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf 12/10/2014
AP08/18/2014SCM       
AP03/6/2015SCM       
AP012/3/2014SLR41157008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf 12/4/2014
AP012/3/2014SLR41192008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf 12/10/2014
AP011/14/2014SLR41013009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s009ltr.pdf 11/18/2014
AP012/3/2014SLR41156010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf 12/4/2014
AP012/3/2014SLR41193010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf 12/10/2014
AP012/3/2014SLR46656010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204063Orig1s010.pdf 7/28/2016
AP06/16/2015SCM       
AP07/14/2015SCM       
AP010/16/2015SCM       
AP02/29/2016SLR45301014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204063Orig1s014ltr.pdf 3/2/2016
AP02/29/2016SLR45361014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf 3/3/2016
AP012/24/2015SCM       
AP08/11/2016SCM       




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