Drug
Who makes dabrafenib?
2 companies list dabrafenib as a human prescription drug, including under the names Tafinlar. Forms: capsule; tablet, for suspension. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing dabrafenib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novartis Pharmaceuticals CorporationSwitzerland | capsule; tablet, for suspension | NDANDA202806, NDA217514 | 3 | 20 |
| Novartis Pharma Stein AG | tablet, for suspension | DRUG FOR FURTHER PROCESSING | 1 | 0 |
Bulk ingredient listings
- Novartis Pharmaceuticals CorporationSwitzerland · 1 NDC
Enquiry
Common questions
- Who makes dabrafenib?
- 2 companies list dabrafenib as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Novartis Pharma Stein AG. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Who supplies dabrafenib active ingredient?
- 1 company lists dabrafenib as a bulk ingredient, including Novartis Pharmaceuticals Corporation.