Application 761154
- Type
- BLA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HULIO | ADALIMUMAB-FKJP | INJECTABLE;INJECTION | 20MG;0.4ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81119 | SUPPL | 2025-02-07 |
| 81118 | SUPPL | 2025-02-07 |
| 77117 | SUPPL | 2023-12-22 |
| 77043 | SUPPL | 2023-12-19 |
| 75308 | SUPPL | 2023-08-29 |
| 75303 | SUPPL | 2023-08-28 |
| 73934 | SUPPL | 2023-04-03 |
| 73927 | SUPPL | 2023-04-03 |
| 71568 | SUPPL | 2022-07-15 |
| 71561 | SUPPL | 2022-07-15 |
| 64790 | ORIG | 2020-10-02 |
| 63812 | ORIG | 2020-07-07 |
| 63811 | ORIG | 2020-07-07 |
| 63808 | ORIG | 2020-07-07 |