An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 201848
Company: DELCATH SYSTEMS INC

REMS

Products on NDA 201848

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEPZATO	MELPHALAN HYDROCHLORIDE	EQ 50MG BASE/VIAL	POWDER;INTRA-ARTERIAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201848

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2023	ORIG-1	Approval	Type 4 - New Combination	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201848Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/201848Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/04/2025	SUPPL-15	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/201848Orig1s015ltr.pdf
07/30/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/01/2024	SUPPL-7	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s007ltr.pdf
07/10/2024	SUPPL-5	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s005ltr.pdf
01/22/2024	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s004Correctedltr.pdf
05/22/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s003ltr.pdf

Labels for NDA 201848

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-5	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s005lbl.pdf
05/22/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s003lbl.pdf
08/14/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf

Top