Hepzato Kit

Delcath Systems, Inc.🇺🇸 United States

FDA Page

Effective Date: Jun 9, 2026
Approval ID: 4f83c8f7-4cc0-4219-88d5-7cfddce91198
Products: 1 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HEPZATO safely and effectively. See full prescribing information for HEPZATO KIT and HEPZATO KIT Hepatic Delivery System Instructions for Use. HEPZATO (melphalan) for injection is a component of the HEPZATO KIT Hepatic Delivery System (HDS) for intra-arterial use. Initial U.S. Approval: 1964

Quick Stats

Total Products1

Labelers2

Label Sections39

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.