Active ingredient
Tafenoquine
3 finished FDA listings contain Tafenoquine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TAFENOQUINE, TAFENOQUINE SUCCINATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 100 mg/1 · 150 mg/1
- Brand names in FDA listings
- Arakoda, Kodatef, Krintafel
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2054023
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 210795 | GLAXOSMITHKLINE | 2018-07-20 | 1 |
| NDA 210607 | 60 DEGREES PHARMS | 2018-08-08 | 1 |
Official labeling on DailyMed
- KRINTAFEL (TAFENOQUINE SUCCINATE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] · version 13 · 2026-07-03
- KODATEF (TAFENOQUINE) TABLET, FILM COATED [60 DEGREES PHARMACEUTICALS, INC] · version 4 · 2025-02-21
- ARAKODA (TAFENOQUINE) TABLET, FILM COATED [60 DEGREES PHARMACEUTICALS, INC.] · version 6 · 2025-01-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.