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FDA NDA · NDA204063

TECFIDERA

dimethyl fumarate

Sponsor: BIOGEN

APPLICATION
NDA204063
TYPE
NDA
ORIGINAL APPROVAL
2013-03-27
LATEST ACTION
2024-03-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

TECFIDERA · ReferencePrescription
DIMETHYL FUMARATE 120MG · CAPSULE, DELAYED RELEASE · ORAL
TECFIDERA · ReferencePrescription
DIMETHYL FUMARATE 240MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-03-12Labeling · Supplement 31 · standard — Label ↗AP
2023-12-13Labeling · Supplement 32 · standard — Letter ↗AP
2023-02-10Efficacy · Supplement 29 · standard — Letter ↗AP
2022-09-29Labeling · Supplement 28 · standard — Letter ↗AP
2022-09-29Labeling · Supplement 30 · standard — Letter ↗AP
2022-02-10Labeling · Supplement 27 · standard — Label ↗AP
2021-01-29Labeling · Supplement 26 · standard — Label ↗AP
2020-02-05Efficacy · Supplement 23 · standard — Letter ↗AP
2019-12-11Labeling · Supplement 25 · standard — Letter ↗AP
2019-07-10Labeling · Supplement 24 · standard — Letter ↗AP
2017-12-15Labeling · Supplement 20 · standard — Letter ↗AP
2017-01-19Labeling · Supplement 17 · standard — Label ↗AP
2016-02-29Labeling · Supplement 14 · standard — Label ↗AP
2015-12-24Manufacturing (CMC) · Supplement 15 · standardAP
2015-10-16Manufacturing (CMC) · Supplement 13 · standardAP
2015-07-14Manufacturing (CMC) · Supplement 12 · standardAP
2015-06-16Manufacturing (CMC) · Supplement 11 · standardAP
2015-03-06Manufacturing (CMC) · Supplement 6 · standardAP
2014-12-03Efficacy · Supplement 3 · standard — Label ↗AP
2014-12-03Labeling · Supplement 10 · standard — Label ↗AP
2014-12-03Labeling · Supplement 8 · standard — Label ↗AP
2014-11-14Labeling · Supplement 9 · standard — Letter ↗AP
2014-08-18Manufacturing (CMC) · Supplement 5 · standardAP
2013-08-20Manufacturing (CMC) · Supplement 2 · standardAP
2013-03-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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