General MedicationsORALStandard
ICLUSIG
PONATINIB HYDROCHLORIDE
Standard Dose
EQ 30MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ICLUSIG is listed in Drugs@FDA under application 203469 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PONATINIB HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 30MG BASE Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2025-10-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview ICLUSIG is listed in Drugs@FDA under application 203469 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PONATINIB HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 30MG BASE Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2025-10-10 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.