General MedicationsORALStandard
XOFLUZA
BALOXAVIR MARBOXIL
Standard Dose
2MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview XOFLUZA is listed in Drugs@FDA under application 214410 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BALOXAVIR MARBOXIL Form and strength FOR SUSPENSION;ORAL - 2MG/ML Sponsor GENENTECH INC Submission history Latest submission status date: 2025-05-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview XOFLUZA is listed in Drugs@FDA under application 214410 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BALOXAVIR MARBOXIL Form and strength FOR SUSPENSION;ORAL - 2MG/ML Sponsor GENENTECH INC Submission history Latest submission status date: 2025-05-30 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.