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FDA NDA · NDA219972

HYRNUO

sevabertinib

Sponsor: BAYER HEALTHCARE

APPLICATION
NDA219972
TYPE
NDA
ORIGINAL APPROVAL
2025-11-19
LATEST ACTION
2025-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYRNUO · ReferencePrescription
SEVABERTINIB 10MG · TABLET · ORAL

Approval history

2025-11-19Type 1 - New Molecular Entity · Original · priorityLabelAP
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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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