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Shingrix

Zoster Vaccine Recombinant, Adjuvanted

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Shingrix

Proper name

Zoster Vaccine Recombinant, Adjuvanted

Licence type

351(a)

BLA number

125614

Applicant

GlaxoSmithKline Biologicals

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
0.5ML	Injection	Intramuscular	Single-Dose Vial	Rx	October 20, 2017
50UG	For Injection	Intramuscular	Vial	Rx	July 23, 2021
50UG	Injection	Intramuscular	Pre-Filled Syringe	Rx	July 16, 2025

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