Active ingredient
Dabrafenib
3 finished FDA listings contain Dabrafenib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DABRAFENIB MESYLATE
- Dosage forms
- Capsule, Tablet, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Tafinlar
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1424911
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 202806 | NOVARTIS | 2013-05-29 | 2 |
| NDA 217514 | NOVARTIS | 2023-03-16 | 1 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.