Product Details for: Engerix-B

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
20UG/ML
Pre-Filled Syringe
351(a)
Engerix-B
Rx
002
Injection
Intramuscular
20UG/ML
Single-Dose Vial
351(a)
Engerix-B
Rx
003
Injection
Intramuscular
10UG/.5ML
Pre-Filled Syringe
351(a)
Engerix-B
Rx
004
Injection
Intramuscular
10UG/.5ML
Single-Dose Vial
351(a)
Engerix-B
Rx
Proper Name
Hepatitis B Vaccine (Recombinant)
BLA Number
103239
Applicant
GlaxoSmithKline Biologicals
Original Approval Date
August 28, 1989
Date of First Licensure
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