Active ingredient
Mirdametinib
3 finished FDA listings contain Mirdametinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MIRDAMETINIB
- Dosage forms
- Capsule, Tablet, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 1 mg/1 · 2 mg/1
- Brand names in FDA listings
- Gomekli
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2705551
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 219389 | SPRINGWORKS | 2025-02-11 | 2 |
| NDA 219379 | SPRINGWORKS | 2025-02-11 | 1 |
Official labeling on DailyMed
No DailyMed labels matched by set ID.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.