Application 761340
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPYSQLI | ECULIZUMAB-AAGH | INJECTION;SOLUTION | 300 mg/30 mL (10 mg/mL) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85780 | SUPPL | 2026-04-30 |
| 84832 | SUPPL | 2026-01-26 |
| 84769 | ORIG | 2026-01-15 |
| 84342 | ORIG | 2025-12-01 |
| 84143 | SUPPL | 2025-11-13 |
| 83275 | SUPPL | 2025-09-03 |
| 82151 | SUPPL | 2025-05-05 |
| 82283 | SUPPL | 2025-04-30 |
| 82160 | SUPPL | 2025-04-30 |
| 81567 | SUPPL | 2025-03-14 |
| 81553 | ORIG | 2025-03-13 |
| 81126 | SUPPL | 2025-02-07 |
| 80913 | SUPPL | 2025-02-04 |
| 80912 | SUPPL | 2025-02-04 |
| 80242 | SUPPL | 2024-11-19 |
| 80231 | SUPPL | 2024-11-18 |
| 80230 | SUPPL | 2024-11-18 |
| 79133 | ORIG | 2024-07-22 |
| 79132 | ORIG | 2024-07-22 |