FDA NDA · NDA218436

RHAPSIDO

Sponsor: NOVARTIS

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APPLICATION
NDA218436
TYPE
NDA
ORIGINAL APPROVAL
2025-09-30
LATEST ACTION
2026-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RHAPSIDO · ReferencePrescription
REMIBRUTINIB 25MG · TABLET · ORAL

Approval history

2026-10-06Efficacy · Supplement 1 · standard — Letter ↗AP
2025-09-30Type 1 - New Molecular Entity · Original · priority — Letter ↗AP