← FDA DRUG APPROVALS

FDA NDA · NDA202992

AUBAGIO

teriflunomide

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA202992
TYPE
NDA
ORIGINAL APPROVAL
2012-09-12
LATEST ACTION
2026-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AUBAGIO · ReferencePrescription
TERIFLUNOMIDE 7MG · TABLET · ORAL
AUBAGIO · ReferencePrescription
TERIFLUNOMIDE 14MG · TABLET · ORAL

Approval history

2026-02-11Labeling · Supplement 18 · standard — Letter ↗AP
2024-06-10Labeling · Supplement 17 · standard — Letter ↗AP
2021-04-30Labeling · Supplement 15 · standard — Letter ↗AP
2021-04-30Efficacy · Supplement 13 · standard — Letter ↗AP
2020-11-06Labeling · Supplement 14 · standard — Label ↗AP
2020-11-06Labeling · Supplement 12 · standard — Letter ↗AP
2020-02-28Labeling · Supplement 10 · standard — Letter ↗AP
2019-09-06Labeling · Supplement 8 · standard — Letter ↗AP
2019-07-24Efficacy · Supplement 6 · standard — Letter ↗AP
2017-12-19Labeling · Supplement 4 · standard — Letter ↗AP
2016-11-29Labeling · Supplement 2 · standard — Letter ↗AP
2016-06-02Labeling · Supplement 3 · standard — Label ↗AP
2014-10-17Efficacy · Supplement 1 · standard — Label ↗AP
2012-09-12Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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