Product Details for: Vaxelis

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
0.5ML
Single-Dose Vial
351(a)
Vaxelis
Rx
002
Injection
Intramuscular
0.5ML
Pre-Filled Syringe
351(a)
Vaxelis
Rx
Proper Name
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine
BLA Number
125563
Applicant
MSP Vaccine Company
Original Approval Date
December 21, 2018
Date of First Licensure
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