Product Details for: Havrix

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
720ELISA U/.5ML
Pre-Filled Syringe
351(a)
Havrix
Rx
002
Injection
Intramuscular
720ELISA U/.5ML
Single-Dose Vial
351(a)
Havrix
Rx
003
Injection
Intramuscular
1440ELISA U/ML
Pre-Filled Syringe
351(a)
Havrix
Rx
004
Injection
Intramuscular
1440ELISA U/ML
Single-Dose Vial
351(a)
Havrix
Rx
Proper Name
Hepatitis A Vaccine
BLA Number
103475
Applicant
GlaxoSmithKline Biologicals
Original Approval Date
February 22, 1995
Date of First Licensure
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