# OZILTUS
> **BLA761457** · Biologics License Application · Sponsor: AMNEAL PHARMS LLC · Approved 2025-12-19
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761457)
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