Product Details for: Dengvaxia
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50
Single-Dose Vial
351(a)
Dengvaxia
Rx
Proper Name
Dengue Tetravalent Vaccine, Live
Dengue Tetravalent Vaccine, Live
BLA Number
125682
125682
Applicant
Sanofi Vaccines US Inc.
Sanofi Vaccines US Inc.
Original Approval Date
May 1, 2019
May 1, 2019
Date of First Licensure
1-May-19
1-May-19