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Ebanga
ansuvimab-zykl
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ebanga
Proper name
ansuvimab-zykl
Licence type
351(a)
BLA number
761172
Applicant
Emergent BioDefense Operations Lansing LLC
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 400MG | For Injection | Intravenous | Single-Dose Vial | Rx | December 21, 2020 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 21, 2027 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |