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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
90 MG/.5ML
Vial
351(a)
N/A
Disc
Proper Name
Influenza Virus Vaccine, H5N1
Influenza Virus Vaccine, H5N1
BLA Number
125244
125244
Applicant
Sanofi Vaccines US Inc.
Sanofi Vaccines US Inc.
Original Approval Date
April 17, 2007
April 17, 2007
Date of First Licensure