Application 761024
- Type
- BLA
- Sponsor
- AMGEN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMJEVITA | ADALIMUMAB-ATTO | INJECTABLE;INJECTION | 20MG/0.4ML | No | No |
| 002 | AMJEVITA | ADALIMUMAB-ATTO | INJECTABLE;INJECTION | 40MG/0.8ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83809 | SUPPL | 2025-10-20 |
| 83801 | SUPPL | 2025-10-17 |
| 83800 | SUPPL | 2025-10-17 |
| 83387 | SUPPL | 2025-09-18 |
| 83385 | SUPPL | 2025-09-18 |
| 82221 | SUPPL | 2025-05-21 |
| 82229 | SUPPL | 2025-05-20 |
| 81914 | SUPPL | 2025-04-09 |
| 81841 | SUPPL | 2025-04-08 |
| 79457 | SUPPL | 2024-08-21 |
| 79453 | SUPPL | 2024-08-21 |
| 75088 | SUPPL | 2023-08-16 |
| 75072 | SUPPL | 2023-08-15 |
| 74762 | SUPPL | 2023-07-14 |
| 74748 | SUPPL | 2023-07-13 |
| 73963 | SUPPL | 2023-04-07 |
| 73962 | SUPPL | 2023-04-07 |
| 73830 | SUPPL | 2023-03-23 |
| 73824 | SUPPL | 2023-03-23 |
| 71668 | SUPPL | 2022-07-29 |
| 71667 | SUPPL | 2022-07-29 |
| 71665 | SUPPL | 2022-07-29 |
| 59094 | SUPPL | 2019-06-17 |
| 59068 | SUPPL | 2019-06-14 |
| 59067 | SUPPL | 2019-06-14 |
| 53059 | SUPPL | 2018-03-20 |
| 53040 | SUPPL | 2018-03-16 |
| 49717 | ORIG | 2017-09-12 |
| 45862 | ORIG | 2016-11-09 |
| 45479 | ORIG | 2016-09-26 |
| 62864 | ORIG | 1900-01-01 |
| 51439 | ORIG | 1900-01-01 |
| 51438 | ORIG | 1900-01-01 |
| 51437 | ORIG | 1900-01-01 |
| 51436 | ORIG | 1900-01-01 |
| 51435 | ORIG | 1900-01-01 |
| 51434 | ORIG | 1900-01-01 |
| 51433 | ORIG | 1900-01-01 |
| 51432 | ORIG | 1900-01-01 |
| 51431 | ORIG | 1900-01-01 |