← FDA DRUG APPROVALS

FDA NDA · NDA214410

XOFLUZA

baloxavir marboxil

Sponsor: GENENTECH INC

APPLICATION
NDA214410
TYPE
NDA
ORIGINAL APPROVAL
2020-11-23
LATEST ACTION
2025-05-30
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

XOFLUZA · ReferencePrescription
BALOXAVIR MARBOXIL 30MG/PACKET · FOR SUSPENSION · ORAL
XOFLUZA · ReferencePrescription
BALOXAVIR MARBOXIL 40MG/PACKET · FOR SUSPENSION · ORAL
XOFLUZA · ReferencePrescription
BALOXAVIR MARBOXIL 2MG/ML · FOR SUSPENSION · ORAL

Approval history

2025-05-30Efficacy · Supplement 8 · standard — Letter ↗AP
2024-12-19Efficacy · Supplement 7 · standard — Letter ↗AP
2024-03-01Efficacy · Supplement 6 · standard — Label ↗AP
2023-06-15Labeling · Supplement 5 · standard — Label ↗AP
2022-08-11Efficacy · Original · standard — Label ↗AP
2021-09-27Labeling · Supplement 1 · standard — Letter ↗AP
2020-11-23Type 3 - New Dosage Form · Original · standard — 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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