Application 761058
- Type
- BLA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYLTEZO | ADALIMUMAB-ADBM | INJECTABLE;INJECTION | 40MG/0.8ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83872 | SUPPL | 2025-10-22 |
| 83871 | SUPPL | 2025-10-22 |
| 83808 | SUPPL | 2025-10-20 |
| 82220 | SUPPL | 2025-05-21 |
| 82233 | SUPPL | 2025-05-20 |
| 78394 | SUPPL | 2024-05-03 |
| 78393 | SUPPL | 2024-05-03 |
| 74865 | SUPPL | 2023-07-21 |
| 74804 | SUPPL | 2023-07-20 |
| 74683 | SUPPL | 2023-07-03 |
| 74337 | SUPPL | 2023-05-22 |
| 74317 | SUPPL | 2023-05-19 |
| 73828 | SUPPL | 2023-03-23 |
| 73825 | SUPPL | 2023-03-23 |
| 73393 | SUPPL | 2023-02-06 |
| 73392 | SUPPL | 2023-02-06 |
| 72255 | SUPPL | 2022-10-05 |
| 72240 | SUPPL | 2022-10-04 |
| 69037 | SUPPL | 2021-10-20 |
| 69017 | SUPPL | 2021-10-19 |
| 69016 | SUPPL | 2021-10-19 |
| 60017 | SUPPL | 2019-09-17 |
| 60006 | SUPPL | 2019-09-16 |
| 60005 | SUPPL | 2019-09-16 |
| 55638 | ORIG | 2018-09-27 |
| 49546 | ORIG | 2017-08-28 |
| 49544 | ORIG | 2017-08-25 |