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 | Title | Submission type | Submission no. | Date | Storage |
|---|
| 84811 | 0 | SUPPL | 9 | 2026-01-21 | Cached in FDA.report object storage |
| 84810 | 0 | SUPPL | 9 | 2026-01-21 | Cached in FDA.report object storage |
| 84778 | 0 | SUPPL | 9 | 2026-01-20 | Cached in FDA.report object storage |
| 83114 | 0 | SUPPL | 7 | 2025-08-18 | Cached in FDA.report object storage |
| 83113 | 0 | SUPPL | 6 | 2025-08-18 | Cached in FDA.report object storage |
| 83112 | 0 | SUPPL | 6 | 2025-08-18 | Cached in FDA.report object storage |
| 83104 | 0 | SUPPL | 7 | 2025-08-18 | Cached in FDA.report object storage |
| 82482 | 0 | ORIG | 2 | 2025-06-09 | Cached in FDA.report object storage |
| 82167 | 0 | ORIG | 1 | 2025-05-08 | Cached in FDA.report object storage |
| 82157 | 0 | ORIG | 2 | 2025-05-05 | Cached in FDA.report object storage |
| 82139 | 0 | SUPPL | 4 | 2025-05-05 | Cached in FDA.report object storage |
| 82271 | 0 | SUPPL | 4 | 2025-04-30 | Cached in FDA.report object storage |
| 82269 | 0 | ORIG | 2 | 2025-04-30 | Cached in FDA.report object storage |
| 82006 | 0 | SUPPL | 1 | 2025-04-25 | Cached in FDA.report object storage |
| 81949 | 0 | SUPPL | 1 | 2025-04-21 | Cached in FDA.report object storage |
| 81776 | 0 | SUPPL | 2 | 2025-03-28 | Cached in FDA.report object storage |
| 81722 | 0 | SUPPL | 2 | 2025-03-25 | Cached in FDA.report object storage |
| 81306 | 0 | SUPPL | 3 | 2025-02-21 | Cached in FDA.report object storage |
| 81297 | 0 | SUPPL | 3 | 2025-02-20 | Cached in FDA.report object storage |
| 79775 | 0 | ORIG | 1 | 2024-09-30 | Cached in FDA.report object storage |
| 79761 | 0 | ORIG | 1 | 2024-09-30 | Cached in FDA.report object storage |