NAGLAZYME
These highlights do not include all the information needed to use NAGLAZYME safely and effectively. See full prescribing information for NAGLAZYME. NAGLAZYME (galsulfase) injection, for intravenous useInitial U.S. Approval: 2005
Approved
Approval ID
59341250-deac-ed71-3823-a4f5d64dbd77
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2020
Manufacturers
FDA
BioMarin Pharmaceutical Inc.
DUNS: 079722386
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
galsulfase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68135-020
Application NumberBLA125117
Product Classification
M
Marketing Category
C73585
G
Generic Name
galsulfase
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 14, 2020
FDA Product Classification
INGREDIENTS (1)
GALSULFASEActive
Quantity: 5 mg in 5 mL
Code: 59UA429E5G
Classification: ACTIB