Product Details for: Naglazyme
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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
galsulfase
BLA Number
125117
125117
Applicant
BioMarin Pharmaceutical Inc.
BioMarin Pharmaceutical Inc.
Original Approval Date
May 31, 2005
May 31, 2005
Date of First Licensure