# DENOSUMAB-DSSB
> **BLA761392** · Biologics License Application · Sponsor: SAMSUNG BIOEPIS CO LTD · Approved 2025-10-29
## Drug
- **FDA Application Number:** BLA761392
- **Application type:** Biologics License Application
- **Brand name:** DENOSUMAB-DSSB
- **Generic name:** DENOSUMAB
- **Active ingredients:** DENOSUMAB-DSSB
- **Dosage form:** INJECTABLE
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** SAMSUNG BIOEPIS CO LTD
- **Manufacturer:** Cordavis Limited
- **First approval:** 2025-10-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761392)
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