Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103628
Company: BIOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVONEX INTERFERON BETA-1A 30UG/ML VIAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/1996 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/ifnbbio051796lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/ifnbbio051796l.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2015 SUPPL-5258 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103628Orig1s5258ltr.pdf
08/28/2014 SUPPL-5224 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf
03/13/2013 SUPPL-5206 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103628s5206lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103628Orig1s5206ltr.pdf
08/28/2014 SUPPL-5194 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf
02/27/2012 SUPPL-5191 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf
02/27/2012 SUPPL-5189 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103628s5189,s5191ltr.pdf
08/28/2014 SUPPL-5177 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf
06/20/2007 SUPPL-5132 Supplement

Label is not available on this site.

08/28/2014 SUPPL-5129 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103628Orig1s5129,s5177,s5224,s5194ltr.pdf
02/02/2007 SUPPL-5115 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103628s5115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103628s5115 ltr.pdf
02/23/2005 SUPPL-5074 Supplement

Label is not available on this site.

12/30/2004 SUPPL-5069 Supplement

Label is not available on this site.

03/26/2004 SUPPL-5053 Supplement

Label is not available on this site.

12/23/2003 SUPPL-5050 Supplement

Label is not available on this site.

05/28/2003 SUPPL-5021 Supplement Letter
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio052803L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103628s5021TOC.cfm
11/12/2002 SUPPL-5008 Supplement Label (PDF)
Letter
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbbio111202LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbbio111202L.htm
01/31/2003 SUPPL-5001 Supplement Label
Letter
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio013103LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbbio013103L.htm
06/30/2000 SUPPL-1025 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/22/2015 SUPPL-5258 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf
08/28/2014 SUPPL-5224 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf
08/28/2014 SUPPL-5194 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf
08/28/2014 SUPPL-5177 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf
08/28/2014 SUPPL-5129 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103628s5129s5177s5194s5224lbl.pdf
03/13/2013 SUPPL-5206 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103628s5206lbl.pdf
02/27/2012 SUPPL-5191 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5191lbl.pdf
02/27/2012 SUPPL-5189 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103628s5189lbl.pdf
02/02/2007 SUPPL-5115 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103628s5115lbl.pdf
01/31/2003 SUPPL-5001 Efficacy https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbbio013103LB.htm
11/12/2002 SUPPL-5008 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbbio111202LB.pdf
05/17/1996 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/ifnbbio051796lb.pdf

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