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FDA NDA · NDA213756

KOSELUGO

selumetinib

Sponsor: ASTRAZENECA

APPLICATION
NDA213756
TYPE
NDA
ORIGINAL APPROVAL
2020-04-10
LATEST ACTION
2026-05-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

KOSELUGO · ReferencePrescription
SELUMETINIB SULFATE EQ 25MG BASE · CAPSULE · ORAL
KOSELUGO · ReferencePrescription
SELUMETINIB SULFATE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2026-05-26Labeling · Supplement 7 · standard — Letter ↗AP
2025-11-19Efficacy · Supplement 6 · standard — Label ↗AP
2025-09-10Efficacy · Supplement 5 · priority — Label ↗AP
2024-01-24Efficacy · Supplement 4 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 3 · standard — Letter ↗AP
2020-04-10Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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