Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125104
Company: BIOGEN IDEC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYSABRI NATALIZUMAB 300MG VIAL; SINGLE-USE 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
11/23/2004 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125104_0000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125104s000_Natalizumab.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2019 SUPPL-965 Supplement

Label is not available on this site.

04/18/2018 SUPPL-963 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125104Orig1s960s963ltr.pdf
04/18/2018 SUPPL-960 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125104Orig1s960s963ltr.pdf
08/16/2017 SUPPL-959 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125104Orig1s959ltr.pdf
09/22/2016 SUPPL-958 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s958ltr.pdf
05/18/2016 SUPPL-955 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf
05/18/2016 SUPPL-953 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf
05/12/2015 SUPPL-950 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125104Orig1s950ltr.pdf
12/15/2013 SUPPL-889 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf
12/15/2013 SUPPL-847 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf
12/15/2013 SUPPL-840 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf
05/24/2013 SUPPL-813 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s813lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s813ltr.pdf
09/16/2011 SUPPL-658 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0658lbl.pdf
01/20/2012 SUPPL-576 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125104s576ltr.pdf
10/07/2011 SUPPL-570 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125104s570ltr.pdf
04/01/2011 SUPPL-475 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf
04/01/2011 SUPPL-438 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf
01/21/2010 SUPPL-283 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf
08/25/2008 SUPPL-106 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s106ltr.pdf
10/03/2008 SUPPL-98 Supplement

Label is not available on this site.

08/12/2008 SUPPL-89 Supplement

Label is not available on this site.

10/03/2008 SUPPL-67 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf
01/21/2010 SUPPL-48 Supplement

Label is not available on this site.

01/14/2008 SUPPL-33 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s0033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/125104Orig1s0033.pdf
06/05/2006 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104s015LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125104s015LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104Orig1s015SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/18/2018 SUPPL-963 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf
04/18/2018 SUPPL-963 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf
04/18/2018 SUPPL-960 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf
04/18/2018 SUPPL-960 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf
08/16/2017 SUPPL-959 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf
08/16/2017 SUPPL-959 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf
05/18/2016 SUPPL-955 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf
05/18/2016 SUPPL-953 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf
05/18/2016 SUPPL-953 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf
05/12/2015 SUPPL-950 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf
05/12/2015 SUPPL-950 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf
05/12/2015 SUPPL-950 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf
12/15/2013 SUPPL-889 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf
12/15/2013 SUPPL-847 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf
12/15/2013 SUPPL-840 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf
05/24/2013 SUPPL-813 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s813lbl.pdf
01/20/2012 SUPPL-576 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf
09/16/2011 SUPPL-658 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0658lbl.pdf
04/01/2011 SUPPL-475 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf
04/01/2011 SUPPL-438 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf
01/21/2010 SUPPL-283 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf
10/03/2008 SUPPL-67 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf
08/25/2008 SUPPL-106 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf
01/14/2008 SUPPL-33 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf
06/05/2006 SUPPL-15 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104s015LBL.pdf
11/23/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf

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