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Gardasil

Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Gardasil
Proper name
Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant
Licence type
351(a)
BLA number
125126
Applicant
Merck Sharp & Dohme LLC
Center
CBER
Presentations
1
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
120MCG L1 PROTEIN FROM HPV 6, 11, 16 AND 18 UG/.5ML Injection Intramuscular Syringe Disc June 8, 2006

Sources for this page

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