Product Details for: Naglazyme Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | Injection | Intravenous | 5MG/5ML (1MG/ML) | Single-Dose Vial | 351(a) | Naglazyme | Rx |
Proper Name
galsulfase
BLA Number
125117
Applicant
BioMarin Pharmaceutical Inc.
Original Approval Date
May 31, 2005
Date of First Licensure