Application 761059
- Type
- BLA
- Sponsor
- SAMSUNG BIOEPIS CO LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HADLIMA | ADALIMUMAB-BWWD | INJECTABLE;INJECTION | 40MG/0.8ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85792 | SUPPL | 2026-05-01 |
| 83859 | SUPPL | 2025-10-21 |
| 83824 | SUPPL | 2025-10-20 |
| 83823 | SUPPL | 2025-10-20 |
| 82654 | SUPPL | 2025-06-24 |
| 82647 | SUPPL | 2025-06-24 |
| 82225 | SUPPL | 2025-05-21 |
| 82224 | SUPPL | 2025-05-21 |
| 82219 | SUPPL | 2025-05-21 |
| 82218 | SUPPL | 2025-05-21 |
| 79865 | SUPPL | 2024-10-11 |
| 78961 | SUPPL | 2024-07-02 |
| 74725 | SUPPL | 2023-07-12 |
| 74722 | SUPPL | 2023-07-12 |
| 74640 | SUPPL | 2023-06-27 |
| 74630 | SUPPL | 2023-06-27 |
| 74097 | SUPPL | 2023-04-27 |
| 74096 | SUPPL | 2023-04-27 |
| 73068 | SUPPL | 2023-01-03 |
| 73055 | SUPPL | 2022-12-27 |
| 71825 | SUPPL | 2022-08-17 |
| 71810 | SUPPL | 2022-08-16 |
| 71413 | SUPPL | 2022-06-21 |
| 71412 | SUPPL | 2022-06-21 |
| 71383 | SUPPL | 2022-06-21 |
| 59913 | ORIG | 2019-09-05 |
| 59435 | ORIG | 2019-09-05 |
| 59433 | ORIG | 2019-07-23 |
| 59432 | ORIG | 2019-07-23 |