Application 761379
- Type
- BLA
- Sponsor
- FRESENIUS KABI USA
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761379 | Otulfi | ustekinumab-aauz | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.