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Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent

Influenza Virus Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Proper name
Influenza Virus Vaccine
Licence type
351(a)
BLA number
103914
Applicant
Sanofi Vaccines US Inc.
Center
CBER
Presentations
10
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
180 UG/.5ML Injection Intramuscular Pre-Filled Syringe Rx December 23, 2009
240UG/.7ML Injection Intramuscular Pre-Filled Syringe Rx November 4, 2019
27UG/0.1 Injection Intradermal Syringe Disc May 9, 2011
36UG/.5ML Injection Intradermal Pre-Filled Syringe Disc December 11, 2014
45UG/.5ML Injection Intramuscular Pre-Filled Syringe Rx December 9, 1999
45UG/.5ML Injection Intramuscular Single-Dose Vial Disc December 9, 1999
45UG/.5ML Injection Intramuscular Multi-Dose Vial Rx November 4, 2019
60UG/.5ML Injection Intramuscular Pre-Filled Syringe Rx June 7, 2013
60UG/.5ML Injection Intramuscular Single-Dose Vial Disc June 7, 2013
60UG/.5ML Injection Intramuscular Multi-Dose Vial Rx June 7, 2013

Sources for this page

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