FdaApplication
NDA 201848
Identifiers
- fda_app_no: NDA201848
Properties
| Property | Value |
|---|---|
| applicant_name | DELCATH SYSTEMS INC |
| application_type | NDA |
| approval_date | 2023-08-14 |
Revenue by product
HEPZATO
| Period | Revenue |
|---|---|
| Q2 2026 | $27.2M |
| Q1 2026 | $23.2M |
| Q4 2025 | $19.1M |
| Q3 2025 | $19.3M |
| Q2 2024 | $6.6M |
| Q1 2024 | $2.0M |
| Q2 2023 | $0.0M |
| Q1 2023 | $0.0M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| HEPZATO | MELPHALAN HYDROCHLORIDE | EQ 50MG BASE/VIAL | POWDER;INTRA-ARTERIAL |
1 product