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HEPZATO

NDA · New Drug Application · Sponsor: DELCATH SYSTEMS INC · Approved 2023-08-14

Drug application

FDA Application #

NDA201848

Application type

New Drug Application

Brand name

HEPZATO

Generic name

MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Active ingredients

MELPHALAN HYDROCHLORIDE

Dosage form

POWDER

Route

INTRA-ARTERIAL

Marketing status

Prescription

Sponsor

DELCATH SYSTEMS INC

Manufacturer

Delcath Systems, Inc.

First approval

2023-08-14

Source

Authoritative

Drugs@FDA application overview

Machine

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