Product Details for: Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
45UG/.5ML
Pre-Filled Syringe
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Rx
002
Injection
Intramuscular
45UG/.5ML
Single-Dose Vial
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Disc
003
Injection
Intramuscular
180 UG/.5ML
Pre-Filled Syringe
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Rx
004
Injection
Intradermal
27UG/0.1
Syringe
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Disc
005
Injection
Intramuscular
60UG/.5ML
Pre-Filled Syringe
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Rx
006
Injection
Intramuscular
60UG/.5ML
Single-Dose Vial
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Disc
007
Injection
Intramuscular
60UG/.5ML
Multi-Dose Vial
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Rx
008
Injection
Intradermal
36UG/.5ML
Pre-Filled Syringe
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Disc
009
Injection
Intramuscular
240UG/.7ML
Pre-Filled Syringe
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Rx
010
Injection
Intramuscular
45UG/.5ML
Multi-Dose Vial
351(a)
Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent
Rx
Proper Name
Influenza Virus Vaccine
BLA Number
103914
Applicant
Sanofi Vaccines US Inc.
Original Approval Date
December 9, 1999
Date of First Licensure
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