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Gardasil 9

Human Papillomavirus 9-valent Vaccine, Recombinant

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Gardasil 9

Proper name

Human Papillomavirus 9-valent Vaccine, Recombinant

Licence type

351(a)

BLA number

125508

Applicant

Merck Sharp & Dohme LLC

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	Pre-Filled Syringe	Rx	December 10, 2014
0.5ML	Injection	Intramuscular	Single-dose vial	Rx	December 10, 2014

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