Active ingredient
Perampanel
34 finished FDA listings contain Perampanel as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PERAMPANEL
- Dosage forms
- Suspension, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- .5 mg/ml · 10 mg/1 · 12 mg/1 · 2 mg/1 · 4 mg/1 · 6 mg/1 · 8 mg/1
- Brand names in FDA listings
- Fycompa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1356552
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 202834 | CATALYST PHARMS | 2012-10-22 | 12 |
| NDA 208277 | CATALYST PHARMS | 2016-04-29 | 2 |
| ANDA 209801 | TEVA PHARMS USA INC | 2025-05-23 | 6 |
| ANDA 218152 | MSN | 2025-07-11 | 1 |
| ANDA 218178 | MSN | 2025-11-25 | 6 |
| ANDA 209538 | TARO | 2025-11-25 | 6 |
| ANDA 219052 | TARO | 2026-06-15 | 1 |
Official labeling on DailyMed
- PERAMPANEL TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 4 · 2026-08-20
- PERAMPANEL SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-06-17
- FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [EISAI INC.] · version 60 · 2026-01-28
- PERAMPANEL SUSPENSION [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2025-12-22
- PERAMPANEL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2025-12-22
- PERAMPANEL TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2025-11-27
- FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [CATALYST PHARMACEUTICALS, INC.] · version 4 · 2024-01-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.