Product Details for: Infanrix
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
25LF/10LF/25UG/.5ML
Pre-Filled Syringe
351(a)
Infanrix
Rx
002
Injection
Intramuscular
25LF/10LF/25UG/.5ML
Single-Dose Vial
351(a)
Infanrix
Rx
Proper Name
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
BLA Number
103647
103647
Applicant
GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals
Original Approval Date
January 29, 1997
January 29, 1997
Date of First Licensure