Application 761118
- Type
- BLA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ABRILADA | ADALIMUMAB-AFZB | INJECTABLE;INJECTION | 40MG/0.8ML | No | No |
| 002 | ABRILADA | ADALIMUMAB-AFZB | INJECTABLE;INJECTION | 20MG/0.4ML | No | No |
| 003 | ABRILADA | ADALIMUMAB-AFZB | INJECTABLE;INJECTION | 10MG/0.2ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84486 | SUPPL | 2025-12-22 |
| 84464 | SUPPL | 2025-12-19 |
| 78897 | SUPPL | 2024-03-15 |
| 78896 | SUPPL | 2024-03-15 |
| 75679 | SUPPL | 2023-10-06 |
| 75678 | SUPPL | 2023-10-06 |
| 75677 | SUPPL | 2023-10-05 |
| 75132 | SUPPL | 2023-08-18 |
| 75098 | SUPPL | 2023-08-17 |
| 74496 | SUPPL | 2023-06-15 |
| 74491 | SUPPL | 2023-06-15 |
| 71689 | SUPPL | 2022-08-01 |
| 71688 | SUPPL | 2022-08-01 |
| 71674 | SUPPL | 2022-08-01 |
| 61712 | ORIG | 2020-01-28 |
| 60958 | ORIG | 2019-11-19 |
| 60860 | ORIG | 2019-11-18 |
| 60859 | ORIG | 2019-11-18 |