Active ingredient
Dichlorphenamide
4 finished FDA listings contain Dichlorphenamide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DICHLORPHENAMIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 50 mg/1
- Brand names in FDA listings
- Keveyis, Ormalvi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3353
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 011366 | XERIS | 1958-07-22 | 1 |
| ANDA 215924 | TORRENT | 2022-12-29 | 2 |
| ANDA 218783 | RISING | 2025-11-18 | 1 |
Official labeling on DailyMed
- DICHLORPHENAMIDE TABLET [TORRENT PHARMACEUTICALS LIMITED] · version 6 · 2026-03-09
- KEVEYIS (DICHLORPHENAMIDE) TABLET [XERIS PHARMACEUTICALS, INC.] · version 9 · 2026-03-05
- DICHLORPHENAMIDE TABLET [RISING PHARMA HOLDINGS, INC.] · version 1 · 2025-11-26
- ORMALVI (DICHLORPHENAMIDE) TABLET [CYCLE PHARMACEUTICALS LTD.] · version 3 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.