ALDURAZYME
These highlights do not include all the information needed to use ALDURAZYME safely and effectively. See full prescribing information for ALDURAZYME. ALDURAZYME (laronidase) injection, for intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
a80ac249-cae4-41f3-88bb-344088b20e60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
laronidase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0070
Application NumberBLA125058
Product Classification
M
Marketing Category
C73585
G
Generic Name
laronidase
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (1)
LARONIDASEActive
Quantity: 2.9 mg in 5 mL
Code: WP58SVM6R4
Classification: ACTIB