General MedicationsORALStandard
TURALIO
PEXIDARTINIB HYDROCHLORIDE
Standard Dose
EQ 125MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary
Approval overview TURALIO is listed in Drugs@FDA under application 211810 (NDA).
Review priority: N/A Marketing status: Prescription Active ingredient PEXIDARTINIB HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 125MG BASE Sponsor DAIICHI SANKYO INC Submission history Latest submission status date: 2025-08-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview TURALIO is listed in Drugs@FDA under application 211810 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient PEXIDARTINIB HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 125MG BASE Sponsor DAIICHI SANKYO INC Submission history Latest submission status date: 2025-08-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: N/A
Interaction Notes
- No interaction notes stored yet.