General MedicationsINTRAVENOUSStandard
UNITUXIN
DINUTUXIMAB
Standard Dose
17.5MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview UNITUXIN is listed in Drugs@FDA under application 125516 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DINUTUXIMAB Form and strength INJECTABLE;INTRAVENOUS - 17.5MG/5ML Sponsor UNITED THERAP Submission history Latest submission status date: 2025-10-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview UNITUXIN is listed in Drugs@FDA under application 125516 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient DINUTUXIMAB Form and strength INJECTABLE;INTRAVENOUS - 17.5MG/5ML Sponsor UNITED THERAP 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.