General MedicationsORALStandard
RHAPSIDO
REMIBRUTINIB
Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview RHAPSIDO is listed in Drugs@FDA under application 218436 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient REMIBRUTINIB Form and strength TABLET;ORAL - 25MG Sponsor NOVARTIS Submission history Latest submission status date: 2025-09-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview RHAPSIDO is listed in Drugs@FDA under application 218436 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient REMIBRUTINIB Form and strength TABLET;ORAL - 25MG Sponsor NOVARTIS Submission history Latest submission status date: 2025-09-30 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.