Application 761071
- Type
- BLA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYRIMOZ | ADALIMUMAB-ADAZ | INJECTABLE;INJECTION | 40MG/0.8ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83835 | SUPPL | 2025-10-21 |
| 83834 | SUPPL | 2025-10-21 |
| 83807 | SUPPL | 2025-10-20 |
| 82999 | SUPPL | 2025-07-31 |
| 82990 | SUPPL | 2025-07-30 |
| 82217 | SUPPL | 2025-05-21 |
| 82231 | SUPPL | 2025-05-20 |
| 78795 | SUPPL | 2024-06-13 |
| 78785 | SUPPL | 2024-06-13 |
| 78097 | SUPPL | 2024-04-09 |
| 78081 | SUPPL | 2024-04-08 |
| 75442 | SUPPL | 2023-09-13 |
| 75389 | SUPPL | 2023-09-11 |
| 74013 | SUPPL | 2023-04-17 |
| 74005 | SUPPL | 2023-04-17 |
| 73866 | SUPPL | 2023-03-27 |
| 73811 | SUPPL | 2023-03-23 |
| 71613 | SUPPL | 2022-07-20 |
| 71612 | SUPPL | 2022-07-20 |
| 71611 | SUPPL | 2022-07-20 |
| 71591 | SUPPL | 2022-07-19 |
| 71590 | SUPPL | 2022-07-19 |
| 70647 | SUPPL | 2022-03-29 |
| 70646 | SUPPL | 2022-03-29 |
| 70641 | SUPPL | 2022-03-29 |
| 66409 | SUPPL | 2021-02-26 |
| 66408 | SUPPL | 2021-02-26 |
| 66362 | SUPPL | 2021-02-25 |
| 58054 | ORIG | 2019-03-21 |
| 56217 | ORIG | 2019-02-28 |
| 56394 | ORIG | 2018-11-09 |
| 56201 | ORIG | 2018-10-31 |