KOSELUGO

AstraZeneca Pharmaceuticals LP🇺🇸 United States

FDA Page

Effective Date: May 26, 2026
Approval ID: 7d042c61-f28f-4ab5-ab10-d7558c0d49ff
Products: 4 registered
Version: 17

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use KOSELUGO safely and effectively. See full prescribing information for KOSELUGO.KOSELUGO (selumetinib) capsules, for oral useKOSELUGO (selumetinib) oral granulesInitial U.S. Approval: 2020

Quick Stats

Total Products4

Labelers2

Label Sections39

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.