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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202992 | SANOFI AVENTIS US | 2012-09-12 | 2 |
| ANDA 209700 | TEVA PHARMS USA | 2018-09-04 | 4 |
| ANDA 209638 | AUROBINDO PHARMA | 2018-10-26 | 2 |
| ANDA 209663 | GLENMARK SPECLT | 2018-11-15 | 2 |
| ANDA 209668 | ZYDUS PHARMS | 2018-11-30 | 4 |
| ANDA 209690 | ACCORD HLTHCARE | 2019-01-07 | 2 |
| ANDA 209572 | ALEMBIC | 2019-04-19 | 4 |
| ANDA 209623 | MSN | 2019-04-24 | 4 |
| ANDA 209702 | SOMERSET THERAPS LLC | 2020-02-28 | 2 |
| ANDA 209639 | BIOCON PHARMA | 2023-03-13 | 2 |
| ANDA 209598 | HETERO LABS LTD V | 2023-03-13 | 2 |
| ANDA 209555 | NATCO | 2023-05-15 | 2 |
| ANDA 218663 | NEOCUBES PHARMA | 2025-04-07 | 2 |
Official labeling on DailyMed
- TERIFLUNOMIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 5 · 2026-09-10
- TERIFLUNOMIDE TABLET, FILM COATED [CONCORD BIOTECH LIMITED] · version 3 · 2026-07-09
- TERIFLUNOMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] · version 18 · 2026-05-20
- TERIFLUNOMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 5 · 2026-04-22
- TERIFLUNOMIDE TABLET [AUROBINDO PHARMA LIMITED] · version 7 · 2026-04-09
- TERIFLUNOMIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 4 · 2026-03-18
- AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORPORATION] · version 28 · 2026-02-25
- TERIFLUNOMIDE TABLET, FILM COATED [AVKARE] · version 3 · 2026-01-16
- TERIFLUNOMIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] · version 5 · 2025-12-02
- TERIFLUNOMIDE (TERIFLUNOMIDE) TABLET, FILM COATED [BIOCON PHARMA INC.] · version 9 · 2025-09-19
- TERIFLUNOMIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] · version 3 · 2024-08-15
- TERIFLUNOMIDE TABLET [NATCO PHARMA USA LLC] · version 4 · 2024-01-09
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.