Active ingredient
Selumetinib
4 finished FDA listings contain Selumetinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SELUMETINIB, SELUMETINIB SULFATE
- Dosage forms
- Capsule, Granule
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1 · 7.5 mg/1
- Brand names in FDA listings
- Koselugo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2289380
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 213756 | ASTRAZENECA | 2020-04-10 | 2 |
| NDA 219943 | ASTRAZENECA | 2025-09-10 | 2 |
Official labeling on DailyMed
- KOSELUGO (SELUMETINIB) CAPSULE KOSELUGO (SELUMETINIB) GRANULE [ASTRAZENECA PHARMACEUTICALS LP] · version 17 · 2026-06-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.