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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201848

HEPZATO (MELPHALAN HYDROCHLORIDE)
EQ 50MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: MELPHALAN HYDROCHLORIDE
Proprietary Name: HEPZATO
Dosage Form; Route of Administration: POWDER; INTRA-ARTERIAL
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201848
Product Number: 001
Approval Date: Aug 14, 2023
Applicant Holder Full Name: DELCATH SYSTEMS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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