Product Details for: Recombivax, Recombivax Hb

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
5UG/0.5ML
Single-Dose Vial
351(a)
Recombivax, Recombivax Hb
Rx
002
Injection
Intramuscular
40UG/ML
Single-Dose Vial
351(a)
Recombivax, Recombivax Hb
Rx
003
Injection
Intramuscular
10UG/ML
Single-Dose Vial
351(a)
Recombivax, Recombivax Hb
Rx
004
Injection
Intramuscular
10UG/ML
Pre-Filled Syringe
351(a)
Recombivax, Recombivax Hb
Rx
005
Injection
Intramuscular
5UG/0.5ML
Pre-Filled Syringe
351(a)
Recombivax, Recombivax Hb
Rx
Proper Name
Hepatitis B Vaccine (Recombinant)
BLA Number
101066
Applicant
Merck Sharp & Dohme LLC
Original Approval Date
July 23, 1986
Date of First Licensure
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