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Acam2000

Smallpox (Vaccinia) Vaccine, Live

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Acam2000

Proper name

Smallpox (Vaccinia) Vaccine, Live

Licence type

351(a)

BLA number

125158

Applicant

Emergent Product Development Gaithersburg, Inc.

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1.0- 5.0 X 10^8 PFU/ML	Suspension	Percutaneous	Multi-Dose Vial	Rx	August 31, 2007

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