← FDA Drug Approvals (Drugs@FDA)
OZILTUS
BLA · Biologics License Application · Sponsor: AMNEAL PHARMS LLC · Approved 2025-12-19
Drug application
- FDA Application #
BLA761457- Application type
- Biologics License Application
- Brand name
- OZILTUS
- Generic name
- DENOSUMAB-MOBZ
- Active ingredients
- DENOSUMAB-MOBZ
- Dosage form
- INJECTABLE
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Sponsor
- AMNEAL PHARMS LLC
- Manufacturer
- Amneal Pharmaceuticals LLC
- First approval
- 2025-12-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown