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Biothrax

Anthrax Vaccine Adsorbed

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Biothrax

Proper name

Anthrax Vaccine Adsorbed

Licence type

351(a)

BLA number

103821

Applicant

Emergent BioDefense Operations Lansing LLC

Center

CBER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.5ML	Injection	Intramuscular	Multi-Dose Vial	Rx	November 12, 1998
0.5ML	Injection	Subcutaneous	Multi-Dose Vial	Rx	November 12, 1998

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 23, 2022

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity