← FDA Drug Approvals (Drugs@FDA)
KOSELUGO
NDA · New Drug Application · Sponsor: ASTRAZENECA · Approved 2025-09-10
Drug application
- FDA Application #
NDA219943- Application type
- New Drug Application
- Brand name
- KOSELUGO
- Generic name
- SELUMETINIB
- Active ingredients
- SELUMETINIB
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ASTRAZENECA
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- First approval
- 2025-09-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown