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Application 761324
- Type
- BLA
- Sponsor
- GENMAB US, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPKINLY | EPCORITAMAB-BYSP | INJECTABLE;SUBCUTANEOUS | 4MG/0.8ML | No | No |
| 002 | EPKINLY | EPCORITAMAB-BYSP | INJECTABLE;SUBCUTANEOUS | 48MG/0.8ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85608 | SUPPL | 2026-03-31 |
| 85576 | SUPPL | 2026-03-30 |
| 85575 | SUPPL | 2026-03-30 |
| 84226 | SUPPL | 2025-11-19 |
| 84225 | SUPPL | 2025-11-19 |
| 84221 | SUPPL | 2025-11-19 |
| 83347 | SUPPL | 2025-09-12 |
| 83345 | SUPPL | 2025-09-12 |
| 78910 | SUPPL | 2024-06-27 |
| 78904 | SUPPL | 2024-06-27 |
| 74382 | ORIG | 2023-05-26 |
| 74341 | ORIG | 2023-05-22 |
| 74339 | ORIG | 2023-05-22 |