U.S. flag

An official website of the United States government

Purple Book
Database of Licensed Biological Products

Product Details for: Naglazyme
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Intravenous5MG/5ML (1MG/ML)Single-Dose Vial351(a)Naglazyme Rx

Proper Name
galsulfase

BLA Number
125117

Applicant
BioMarin Pharmaceutical Inc.

Original Approval Date
May 31, 2005

Date of First Licensure