Product Details for: Audenz
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
7.5HA UG/.5ML
Multi-Dose Vial
351(a)
Audenz
Disc
Proper Name
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
BLA Number
125692
125692
Applicant
Seqirus Inc.
Seqirus Inc.
Original Approval Date
January 31, 2020
January 31, 2020
Date of First Licensure