# PROLIA
> **BLA125320** · Biologics License Application · Sponsor: AMGEN · Approved 2010-06-01
## Drug
- **FDA Application Number:** BLA125320
- **Application type:** Biologics License Application
- **Brand name:** PROLIA
- **Generic name:** DENOSUMAB
- **Active ingredients:** DENOSUMAB
- **Dosage form:** INJECTABLE
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** AMGEN
- **Manufacturer:** Amgen, Inc
- **First approval:** 2010-06-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125320)
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