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Elfabrio
pegunigalsidase alfa-iwxj
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Elfabrio
Proper name
pegunigalsidase alfa-iwxj
Licence type
351(a)
BLA number
761161
Applicant
Chiesi Farmaceutici S.p.A.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 20MG/10ML (2MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | May 9, 2023 |
| 5MG/2.5ML | Injection | Intravenous | Single-Dose Vial | Rx | May 17, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |