← FDA Drug Approvals (Drugs@FDA)
OTULFI
BLA · Biologics License Application · Sponsor: FRESENIUS KABI USA · Approved 2025-04-30
Drug application
- FDA Application #
BLA761379- Application type
- Biologics License Application
- Brand name
- OTULFI
- Generic name
- USTEKINUMAB-AAUZ
- Active ingredients
- USTEKINUMAB-AAUZ
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- FRESENIUS KABI USA
- Manufacturer
- Fresenius Kabi USA, LLC
- First approval
- 2025-04-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown