# HEPZATO
> **NDA201848** · New Drug Application · Sponsor: DELCATH SYSTEMS INC · Approved 2023-08-14
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201848)
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