HEPZATO KIT (MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION)
Summary
FDA approved HEPZATO KIT (MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) by DELCATH SYSTEMS INC. NDA (New Drug) approval (Labeling) on 2026-05-28. POWDER, INTRA-ARTERIAL.
Details
Source
Drug Approval
External ID
NDA201848-16
Action Date
2026-05-28
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
HEPZATO KIT (generic: MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION), POWDER, INTRA-ARTERIAL. Application: NDA201848
Company
Context & Analysis
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This is the only FDA action we have on record for DELCATH SYSTEMS INC in our database.
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