Active ingredient
Vigabatrin
24 finished FDA listings contain Vigabatrin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- VIGABATRIN
- Dosage forms
- For Solution, Powder, For Solution, Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 16
- Strengths listed
- 100 mg/ml · 50 mg/ml · 500 mg/1 · 500 mg/10ml · 500 mg/ml
- Brand names in FDA listings
- Sabril, Vigabatrin For Oral Solution, Vigadrone, Vigafyde
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 14851
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 020427 | LUNDBECK PHARMS LLC | 2009-08-21 | 1 |
| NDA 022006 | LUNDBECK PHARMS LLC | 2009-08-21 | 1 |
| ANDA 208218 | PH HEALTH | 2017-04-27 | 1 |
| ANDA 210155 | AMNEAL PHARMS | 2018-03-13 | 2 |
| ANDA 210196 | BORA | 2018-06-21 | 1 |
| ANDA 211481 | DR REDDYS | 2018-11-20 | 1 |
| ANDA 209822 | TEVA PHARMS USA | 2019-01-14 | 1 |
| ANDA 211592 | INVAGEN PHARMS | 2019-12-03 | 1 |
| ANDA 213375 | ALKEM LABS LTD | 2020-12-02 | 1 |
| ANDA 213519 | ANNORA PHARMA | 2021-01-26 | 1 |
| ANDA 211539 | DR REDDYS | 2021-01-29 | 1 |
| ANDA 215109 | DEXCEL | 2021-09-23 | 1 |
| ANDA 213899 | AUROBINDO PHARMA LTD | 2021-09-29 | 1 |
| ANDA 215707 | ZYDUS LIFESCIENCES | 2022-01-19 | 2 |
| ANDA 215601 | AUROBINDO PHARMA LTD | 2022-05-10 | 1 |
| ANDA 213104 | HIKMA | 2022-08-29 | 1 |
| ANDA 215363 | MSN | 2022-09-07 | 1 |
| ANDA 214671 | ZYDUS LIFESCIENCES | 2023-03-02 | 2 |
| ANDA 215519 | CARNEGIE | 2023-04-28 | 1 |
| ANDA 214749 | UPSHER SMITH LABS | 2023-06-29 | 1 |
| NDA 217684 | PYROS PHARMS | 2024-06-17 | 1 |
Official labeling on DailyMed
- VIGABATRIN TABLET [EDENBRIDGE PHARMACEUTICALS LLC.] · version 2 · 2026-08-14
- VIGABATRIN FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2026-06-17
- VIGADRONE (VIGABATRIN) POWDER, FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC] · version 9 · 2026-06-17
- VIGABATRIN POWDER, FOR SOLUTION [PAR HEALTH USA, LLC] · version 29 · 2026-04-23
- VIGAFYDE (VIGABATRIN) SOLUTION [UPSHER-SMITH LABORATORIES, LLC] · version 19 · 2026-03-02
- VIGABATRIN TABLET, FILM COATED [CARNEGIE PHARMACEUTICALS LLC] · version 1 · 2026-02-23
- SABRIL (VIGABATRIN) POWDER, FOR SOLUTION [LUNDBECK PHARMACEUTICALS LLC] · version 46 · 2025-12-17
- SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK PHARMACEUTICALS LLC] · version 40 · 2025-12-17
- VIGABATRIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] · version 3 · 2025-11-17
- VIGABATRIN POWDER, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED] · version 2 · 2025-11-17
- VIGABATRIN POWDER, FOR SOLUTION [AUROBINDO PHARMA LIMITED] · version 5 · 2025-07-22
- VIGABATRIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] · version 13 · 2025-05-07
Showing the 12 most recent of 24 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.