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FDA Drug Application 103628 by BIOGEN

Application Number103628
Application Type Biologic License Application
Sponsor ApplicantBIOGEN
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
AP05/17/1996N78870000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/ifnbbio051796l.pdf 3/11/2004
AP05/17/1996N78880000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/ifnbbio051796lb.pdf 3/11/2004
AP05/17/1996N238870000   http://wcms.fda.gov/downloads/Drugs/DrugSafety/ucm085930.pdf 11/16/2009
AP01/31/2003S78905001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio013103L.htm 3/11/2004
AP01/31/2003S78915001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio013103LB.htm 3/11/2004
AP01/31/2003S78925001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/Ifnbbio013103MG.htm 3/11/2004
AP011/12/2002S78975008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbbio111202L.htm 3/11/2004
AP011/12/2002S78985008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbbio111202LB.pdf 3/11/2004
AP05/28/2003S78935021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103628s5021TOC.cfm 3/11/2004
AP05/28/2003S78945021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio052803L.htm 3/11/2004
AP05/28/2003S78955021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio052803MG1.pdf 3/11/2004
AP02/2/2007S158155115   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103628s5115 ltr.pdf 2/12/2007
AP02/2/2007S159035115   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103628s5115lbl.pdf 2/23/2007
AP08/28/2014SLR403705129   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf 9/3/2014
AP08/28/2014SLR403795129   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf 9/3/2014
AP08/28/2014SLR403805177   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf 9/3/2014
AP08/28/2014SLR403715177   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf 9/3/2014
AP02/27/2012SE2319285189   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5189lbl.pdf 2/27/2012
AP02/27/2012SE2319635189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf 2/29/2012
AP02/27/2012SE3319645191   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf 2/29/2012
AP02/27/2012SE3319295191   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5191lbl.pdf 2/27/2012
AP08/28/2014SLR403815194   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf 9/3/2014
AP08/28/2014SLR403735194   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf 9/3/2014
AP03/13/2013SLR354535206   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103628Orig1s5206ltr.pdf 3/15/2013
AP03/13/2013SLR354655206   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103628s5206lbl.pdf 3/15/2013
AP08/28/2014SLR403825224   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf 9/3/2014
AP08/28/2014SLR403725224   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf 9/3/2014
AP012/22/2015S448745258   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103628Orig1s5258ltr.pdf 12/23/2015
AP012/22/2015S448895258   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf 12/28/2015




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