Application 201848
- Type
- NDA
- Sponsor
- DELCATH SYSTEMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HEPZATO | MELPHALAN HYDROCHLORIDE | POWDER;INTRA-ARTERIAL | EQ 50MG BASE/VIAL | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83290 | SUPPL | 2025-09-05 |
| 79809 | SUPPL | 2024-10-03 |
| 79361 | SUPPL | 2024-08-09 |
| 79360 | SUPPL | 2024-08-09 |
| 79324 | ORIG | 2024-08-07 |
| 78547 | SUPPL | 2024-05-23 |
| 78546 | SUPPL | 2024-05-23 |
| 77346 | SUPPL | 2024-01-29 |
| 76358 | ORIG | 2023-11-06 |
| 75071 | ORIG | 2023-08-15 |
| 75067 | ORIG | 2023-08-15 |