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Bat
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bat
Proper name
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
Licence type
351(a)
BLA number
125462
Applicant
Emergent BioSolutions Canada Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| >4500U | Solution | Intravenous | Single-Dose Vial | Rx | March 22, 2013 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | March 22, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |