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Active ingredient

Teriflunomide

34 finished FDA listings contain Teriflunomide as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
TERIFLUNOMIDE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
16
Strengths listed
14 mg/1 · 14 mg/141 · 7 mg/1
Brand names in FDA listings
Aubagio

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1310520

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 202992SANOFI AVENTIS US2012-09-122
ANDA 209700TEVA PHARMS USA2018-09-044
ANDA 209638AUROBINDO PHARMA2018-10-262
ANDA 209663GLENMARK SPECLT2018-11-152
ANDA 209668ZYDUS PHARMS2018-11-304
ANDA 209690ACCORD HLTHCARE2019-01-072
ANDA 209572ALEMBIC2019-04-194
ANDA 209623MSN2019-04-244
ANDA 209702SOMERSET THERAPS LLC2020-02-282
ANDA 209639BIOCON PHARMA2023-03-132
ANDA 209598HETERO LABS LTD V2023-03-132
ANDA 209555NATCO2023-05-152
ANDA 218663NEOCUBES PHARMA2025-04-072

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.