Product Details for: Xenpozyme

RETURN TO SEARCH RESULTS
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
For Injection
Intravenous
20MG
Single-Dose Vial
351(a)
Xenpozyme
Rx
002
For Injection
Intravenous
4MG
Single-Dose Vial
351(a)
Xenpozyme
Rx
Proper Name
olipudase alfa-rpcp
BLA Number
761261
Applicant
Genzyme Corporation
Original Approval Date
August 31, 2022
Date of First Licensure
RETURN TO SEARCH RESULTS