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Revcovi
elapegademase-lvlr
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Revcovi
Proper name
elapegademase-lvlr
Licence type
351(a)
BLA number
761092
Applicant
Chiesi USA, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2.4MG/1.5ML (1.6MG/ML) | Injection | Intramuscular | Single-Dose Vial | Rx | October 5, 2018 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 5, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |