General MedicationsORALStandard
IDHIFA
ENASIDENIB MESYLATE
Standard Dose
EQ 100MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview IDHIFA is listed in Drugs@FDA under application 209606 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ENASIDENIB MESYLATE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2025-01-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview IDHIFA is listed in Drugs@FDA under application 209606 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ENASIDENIB MESYLATE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2025-01-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.