Application 761299
- Type
- BLA
- Sponsor
- ALVOTECH USA INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIMLANDI | ADALIMUMAB-RYVK | INJECTABLE;INJECTION | 40MG/0.4ML | No | No |
Documents
| Document | Submission type | Date |
|---|---|---|
| 84129 | SUPPL | 2025-11-07 |
| 84125 | SUPPL | 2025-11-07 |
| 83837 | SUPPL | 2025-10-21 |
| 83836 | SUPPL | 2025-10-21 |
| 83805 | SUPPL | 2025-10-20 |
| 81916 | SUPPL | 2025-04-09 |
| 81915 | SUPPL | 2025-04-09 |
| 81843 | SUPPL | 2025-04-08 |
| 81842 | SUPPL | 2025-04-08 |
| 81299 | SUPPL | 2025-02-20 |
| 81266 | SUPPL | 2025-02-18 |
| 79499 | SUPPL | 2024-08-29 |
| 79498 | SUPPL | 2024-08-29 |
| 79490 | SUPPL | 2024-08-27 |
| 79489 | SUPPL | 2024-08-27 |
| 78976 | SUPPL | 2024-07-05 |
| 78763 | ORIG | 2024-06-11 |
| 78622 | SUPPL | 2024-06-04 |
| 78614 | SUPPL | 2024-06-03 |
| 77625 | ORIG | 2024-02-26 |
| 77620 | ORIG | 2024-02-23 |