FdaApplication
BLA 761379
Identifiers
- fda_app_no: BLA761379
Properties
| Property | Value |
|---|---|
| applicant_name | Fresenius Kabi USA, LLC |
| application_type | BLA |
| approval_date | 2024-09-27 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OTULFI | USTEKINUMAB-AAUZ | 90MG/ML | Injection |
| OTULFI | USTEKINUMAB-AAUZ | 130MG/26ML (5MG/ML) | Injection |
| OTULFI | USTEKINUMAB-AAUZ | 45MG/0.5ML | Injection |
| OTULFI | — | 45MG/0.5ML | Injection |
4 products