Active ingredient
Tiagabine
10 finished FDA listings contain Tiagabine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TIAGABINE HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 12 mg/1 · 16 mg/1 · 2 mg/1 · 4 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 31914
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 020646 | CEPHALON | 1997-09-30 | 4 |
| ANDA 077555 | SUN PHARM INDS | 2011-11-04 | 2 |
| ANDA 214816 | MSN | 2021-11-16 | 4 |
Official labeling on DailyMed
- TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 18 · 2026-04-15
- TIAGABINE HYDROCHLORIDE TABLET [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2021-11-24
- TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 9 · 2018-11-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.