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FDA Drug Application 125104 by BIOGEN IDEC

Application Number125104
Application Type Biologic License Application
Sponsor ApplicantBIOGEN IDEC
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
AP011/23/2004N106490000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf 11/24/2004
AP011/23/2004N106500000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125104_0000_ltr.pdf 11/24/2004
AP011/23/2004N112160000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125104s000_Natalizumab.cfm 3/8/2005
AP011/23/2004N241980000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089809.pdf 12/4/2009
AP011/23/2004N314010000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=63 1/18/2012
AP06/5/2006S142270015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104s015LBL.pdf 6/6/2006
AP06/5/2006S142340015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125104s015LTR.pdf 6/6/2006
AP06/5/2006S383030015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104Orig1s015SumR.pdf 1/16/2014
AP01/14/2008S188730033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf 1/15/2008
AP01/14/2008S189370033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s0033ltr.pdf 1/23/2008
AP01/14/2008S375380033   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/125104Orig1s0033.pdf 10/23/2013
AP04/1/2011S284770438   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf 4/7/2011
AP04/1/2011S284780475   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf 4/7/2011
AP09/16/2011S300920658   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0658lbl.pdf 9/27/2011
AP010/3/2008S21135067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf 11/3/2008
AP010/3/2008S23367067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf 9/16/2009
AP010/3/2008S       
AP08/25/2008S21115106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf 10/31/2008
AP08/25/2008S21136106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s106ltr.pdf 11/3/2008
AP01/21/2010S27937283   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf 11/23/2004
AP010/7/2011S31603570   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125104s570ltr.pdf 1/31/2012
AP01/20/2012SE831566576   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf 1/27/2012
AP01/20/2012SE831596576   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125104s576ltr.pdf 1/31/2012
AP05/24/2013SLR36152813   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s813ltr.pdf 5/28/2013
AP05/24/2013SLR36225813   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s813lbl.pdf 6/4/2013
AP012/15/2013SE838068840   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf 12/17/2013
AP012/15/2013SE838086840   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf 12/17/2013
AP012/15/2013SLR38069847   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf 12/17/2013
AP012/15/2013SLR38087847   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf 12/17/2013
AP012/15/2013SLR38070889   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf 12/17/2013
AP012/15/2013SLR38088889   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf 12/17/2013
AP05/12/2015SLR42801950   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125104Orig1s950ltr.pdf 5/13/2015
AP05/12/2015SLR42815950   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf 5/13/2015
AP05/18/2016SLR46074953   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf 5/20/2016
AP05/18/2016SLR46095953   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf 5/20/2016
AP05/18/2016SLR46075955   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf 5/20/2016
AP05/18/2016SLR46096955   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf 5/20/2016
AP09/22/2016S47333958   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s958ltr.pdf 10/12/2016




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