Active ingredient
Miglustat
7 finished FDA listings contain Miglustat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MIGLUSTAT
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 100 mg/1 · 65 mg/1
- Brand names in FDA listings
- Opfolda, Yargesa, Zavesca
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 402316
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 021348 | ACTELION | 2003-07-31 | 2 |
| ANDA 208342 | ANI PHARMS | 2018-04-17 | 1 |
| ANDA 209821 | EDENBRIDGE PHARMS | 2020-08-06 | 1 |
| NDA 215211 | AMICUS THERAP US | 2023-09-28 | 1 |
| ANDA 219111 | NAVINTA LLC | 2025-03-14 | 2 |
Official labeling on DailyMed
- MIGLUSTAT CAPSULE [NAVINTA LLC] · version 3 · 2026-01-01
- YARGESA (MIGLUSTAT) CAPSULE [EDENBRIDGE PHARMACEUTICALS LLC.] · version 5 · 2025-12-19
- MIGLUSTAT CAPSULE [ANI PHARMACEUTICALS, INC.] · version 7 · 2025-11-27
- MIGLUSTAT CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2025-04-02
- OPFOLDA (MIGLUSTAT) CAPSULE [AMICUS THERAPEUTICS US, LLC] · version 5 · 2024-12-09
- MIGLUSTAT CAPSULE [COTHERIX, INC.] · version 16 · 2023-04-26
- ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] · version 19 · 2023-04-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.