Skip to contentApplication 761333
- Type
- BLA
- Sponsor
- AMGEN INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BKEMV | ECULIZUMAB-AEEB | INJECTABLE;INJECTION | 300MG/30ML(10MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85593 | SUPPL | 2026-03-30 |
| 84317 | SUPPL | 2025-11-25 |
| 84316 | SUPPL | 2025-11-25 |
| 84305 | SUPPL | 2025-11-25 |
| 83386 | SUPPL | 2025-09-18 |
| 82031 | SUPPL | 2025-04-28 |
| 81108 | SUPPL | 2025-02-06 |
| 80961 | ORIG | 2025-02-05 |
| 78572 | ORIG | 2025-02-04 |
| 79984 | SUPPL | 2024-10-25 |
| 79974 | SUPPL | 2024-10-24 |
| 79112 | ORIG | 2024-07-18 |
| 78567 | ORIG | 2024-05-28 |