Application 761255
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IDACIO | ADALIMUMAB-AACF | INJECTABLE;SUBCUTANEOUS | 40MG/0.8ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84713 | SUPPL | 2026-01-06 |
| 84623 | SUPPL | 2025-12-31 |
| 80648 | SUPPL | 2024-12-19 |
| 80628 | SUPPL | 2024-12-19 |
| 80627 | SUPPL | 2024-12-19 |
| 78630 | SUPPL | 2024-07-02 |
| 77193 | ORIG | 2024-07-02 |
| 78653 | SUPPL | 2024-06-05 |
| 78552 | ORIG | 2024-05-24 |
| 77251 | ORIG | 2024-01-22 |
| 76629 | SUPPL | 2023-11-17 |
| 76599 | SUPPL | 2023-11-17 |
| 76032 | SUPPL | 2023-11-02 |
| 76024 | SUPPL | 2023-11-01 |
| 75723 | SUPPL | 2023-10-16 |
| 75709 | SUPPL | 2023-10-12 |
| 73419 | ORIG | 2023-02-09 |
| 72884 | ORIG | 2022-12-15 |
| 72882 | ORIG | 2022-12-14 |