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Dengvaxia

Dengue Tetravalent Vaccine, Live

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Dengvaxia

Proper name

Dengue Tetravalent Vaccine, Live

Licence type

351(a)

BLA number

125682

Applicant

Sanofi Vaccines US Inc.

Center

CBER

Presentations

First licensure

May 1, 2019

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50	For Injection	Subcutaneous	Single-Dose Vial	Rx	May 1, 2019

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