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Pediarix

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Pediarix
Proper name
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine
Licence type
351(a)
BLA number
103907
Applicant
GlaxoSmithKline Biologicals
Center
CBER
Presentations
1
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
0.5ML Injection Intramuscular Pre-Filled Syringe Rx December 13, 2002

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity