← FDA Drug Approvals (Drugs@FDA)
OSENVELT
BLA · Biologics License Application · Sponsor: CELLTRION INC · Approved 2025-02-28
Drug application
- FDA Application #
BLA761404- Application type
- Biologics License Application
- Brand name
- OSENVELT
- Generic name
- DENOSUMAB-BMWO
- Active ingredients
- DENOSUMAB-BMWO
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- CELLTRION INC
- Manufacturer
- CELLTRION USA, Inc.
- First approval
- 2025-02-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown