General MedicationsINTRA-ARTERIALStandard
HEPZATO
MELPHALAN HYDROCHLORIDE
Standard Dose
EQ 50MG BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary
Approval overview HEPZATO is listed in Drugs@FDA under application 201848 (NDA).
Review priority: N/A Marketing status: Prescription Active ingredient MELPHALAN HYDROCHLORIDE Form and strength POWDER;INTRA-ARTERIAL - EQ 50MG BASE/VIAL Sponsor DELCATH SYSTEMS INC Submission history Latest submission status date: 2025-09-04 00:00:00.
Structured Monograph
Clinical summary
Approval overview HEPZATO is listed in Drugs@FDA under application 201848 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient MELPHALAN HYDROCHLORIDE Form and strength POWDER;INTRA-ARTERIAL - EQ 50MG BASE/VIAL Sponsor DELCATH SYSTEMS INC Submission history Latest submission status date: 2025-09-04 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: N/A
Interaction Notes
- No interaction notes stored yet.