General MedicationsORALStandard
INREBIC
FEDRATINIB HYDROCHLORIDE
Standard Dose
EQ 100MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview INREBIC is listed in Drugs@FDA under application 212327 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FEDRATINIB HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 100MG BASE Sponsor BRISTOL-MYERS Submission history Latest submission status date: 2026-03-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview INREBIC is listed in Drugs@FDA under application 212327 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FEDRATINIB HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 100MG BASE Sponsor BRISTOL-MYERS Submission history Latest submission status date: 2026-03-18 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.