Product Details for: GENGLYCOS

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intravenous
3x10^13VG/ML
Single-Dose Vial
351(a)
GENGLYCOS
Rx
Proper Name
pariglasgene brecaparvovec-opnr
BLA Number
125858
Applicant
Ultragenyx Pharmaceutical, Inc.
Original Approval Date
August 19, 2026
Date of First Licensure
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