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Genglycos
pariglasgene brecaparvovec-opnr
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Genglycos
Proper name
pariglasgene brecaparvovec-opnr
Licence type
351(a)
BLA number
125858
Applicant
Ultragenyx Pharmaceutical, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 3x10^13VG/ML | Suspension | Intravenous | Single-Dose Vial | Rx | August 19, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |