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FDA NDA · NDA201848

HEPZATO KIT

melphalan hydrochloride injection, powder, lyophilized, for solution

Sponsor: DELCATH SYSTEMS INC

APPLICATION
NDA201848
TYPE
NDA
ORIGINAL APPROVAL
2023-08-14
LATEST ACTION
2026-06-29
ROUTE
INTRA-ARTERIAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

HEPZATO · ReferencePrescription
MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL · POWDER · INTRA-ARTERIAL

Approval history

2026-06-29Labeling · Supplement 19 · standard — Letter ↗AP
2026-05-28Labeling · Supplement 16 · standard — Letter ↗AP
2025-09-04REMS · Supplement 15 — Letter ↗AP
2025-07-30Labeling · Supplement 10 · standardAP
2024-10-01REMS · Supplement 7 — Letter ↗AP
2024-07-10Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2024-05-22Labeling · Supplement 3 · standard — Label ↗AP
2024-01-22REMS · Supplement 4 — Letter ↗AP
2023-08-14Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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