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FDA NDA · NDA219943

KOSELUGO

selumetinib

Sponsor: ASTRAZENECA

APPLICATION
NDA219943
TYPE
NDA
ORIGINAL APPROVAL
2025-09-10
LATEST ACTION
2026-05-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, GRANULE
MARKETING STATUS
Prescription

Products

KOSELUGOPrescription
SELUMETINIB 10MG · CAPSULE · ORAL
KOSELUGO · ReferencePrescription
SELUMETINIB SULFATE EQ 5MG BASE · GRANULE · ORAL
KOSELUGOPrescription
SELUMETINIB 25MG · CAPSULE · ORAL
KOSELUGO · ReferencePrescription
SELUMETINIB SULFATE EQ 7.5MG BASE · GRANULE · ORAL

Approval history

2026-05-26Labeling · Supplement 3 · standard — Letter ↗AP
2025-11-19Labeling · Supplement 2 · standard — Label ↗AP
2025-09-10Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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