Application 761219
- Type
- BLA
- Sponsor
- CELLTRION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | YUFLYMA | ADALIMUMAB-AATY | INJECTABLE;INJECTION | 40MG/0.4ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83874 | SUPPL | 2025-10-22 |
| 83873 | SUPPL | 2025-10-22 |
| 83806 | SUPPL | 2025-10-20 |
| 82454 | SUPPL | 2025-06-03 |
| 82305 | SUPPL | 2025-05-23 |
| 82227 | SUPPL | 2025-05-21 |
| 82216 | SUPPL | 2025-05-21 |
| 81907 | SUPPL | 2025-04-09 |
| 81840 | SUPPL | 2025-04-08 |
| 80761 | SUPPL | 2024-12-27 |
| 80756 | SUPPL | 2024-12-27 |
| 79441 | SUPPL | 2024-08-20 |
| 79435 | SUPPL | 2024-08-19 |
| 77152 | SUPPL | 2023-12-27 |
| 77149 | SUPPL | 2023-12-27 |
| 77148 | SUPPL | 2023-12-27 |
| 77139 | SUPPL | 2023-12-27 |
| 77138 | SUPPL | 2023-12-27 |
| 77137 | SUPPL | 2023-12-27 |
| 76715 | SUPPL | 2023-12-01 |
| 76707 | SUPPL | 2023-12-01 |
| 74362 | ORIG | 2023-10-03 |
| 75640 | SUPPL | 2023-10-02 |
| 75568 | SUPPL | 2023-09-26 |
| 75549 | SUPPL | 2023-09-25 |
| 75371 | SUPPL | 2023-09-07 |
| 75363 | SUPPL | 2023-09-07 |
| 75042 | ORIG | 2023-08-11 |
| 74359 | ORIG | 2023-05-24 |