Application 761379
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OTULFI | USTEKINUMAB-AAUZ | INJECTABLE;INJECTION | 45MG/0.5ML | No | No |
| 002 | OTULFI | USTEKINUMAB-AAUZ | INJECTABLE;INJECTION | 90MG/1ML | No | No |
| 003 | OTULFI | USTEKINUMAB-AAUZ | INJECTABLE;INJECTION | 130MG/26ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84811 | SUPPL | 2026-01-21 |
| 84810 | SUPPL | 2026-01-21 |
| 84778 | SUPPL | 2026-01-20 |
| 83114 | SUPPL | 2025-08-18 |
| 83113 | SUPPL | 2025-08-18 |
| 83112 | SUPPL | 2025-08-18 |
| 83104 | SUPPL | 2025-08-18 |
| 82482 | ORIG | 2025-06-09 |
| 82167 | ORIG | 2025-05-08 |
| 82157 | ORIG | 2025-05-05 |
| 82139 | SUPPL | 2025-05-05 |
| 82271 | SUPPL | 2025-04-30 |
| 82269 | ORIG | 2025-04-30 |
| 82006 | SUPPL | 2025-04-25 |
| 81949 | SUPPL | 2025-04-21 |
| 81776 | SUPPL | 2025-03-28 |
| 81722 | SUPPL | 2025-03-25 |
| 81306 | SUPPL | 2025-02-21 |
| 81297 | SUPPL | 2025-02-20 |
| 79775 | ORIG | 2024-09-30 |
| 79761 | ORIG | 2024-09-30 |