# NAGLAZYME
> **BLA125117** · Biologics License Application · Sponsor: BIOMARIN · Approved 2005-05-31
## Drug
- **FDA Application Number:** BLA125117
- **Application type:** Biologics License Application
- **Brand name:** NAGLAZYME
- **Generic name:** GALSULFASE
- **Active ingredients:** GALSULFASE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** BIOMARIN
- **Manufacturer:** BioMarin Pharmaceutical Inc.
- **First approval:** 2005-05-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125117)
---
*AI Analytics · CC0 1.0*