Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204063
Company: BIOGEN IDEC INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECFIDERA DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes No
TECFIDERA DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/27/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204063Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204063Orig1s020ltr.pdf
01/19/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204063Orig1s017ltr.pdf
12/24/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/29/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204063Orig1s014ltr.pdf
10/16/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/14/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/16/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/03/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204063Orig1s010.pdf
11/14/2014 SUPPL-9 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s009ltr.pdf
12/03/2014 SUPPL-8 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf
03/06/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/18/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/03/2014 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204063Orig1s003,s008,s010ltr.pdf
08/20/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/15/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s020lbl.pdf
01/19/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204063s017lbl.pdf
02/29/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204063s014lbl.pdf
12/03/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf
12/03/2014 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf
12/03/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf
12/03/2014 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204063s003s008s010lbl.pdf
03/27/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf

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