FDA NDA · NDA221276

HIBSAGO

Sponsor: GLAXOSMITHKLINE LLC

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APPLICATION
NDA221276
TYPE
NDA
ORIGINAL APPROVAL
2026-10-20
LATEST ACTION
2026-10-20
ROUTE
SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

HIBSAGOPrescription
BEPIROVIRSEN · INJECTION · SOLUTION

Approval history

2026-10-20Type 1 - New Molecular Entity · Original · priority — Letter ↗AP