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Nexviazyme
avalglucosidase alfa-ngpt
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Nexviazyme
Proper name
avalglucosidase alfa-ngpt
Licence type
351(a)
BLA number
761194
Applicant
Genzyme Corporation
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | August 6, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |