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Twinrix

Hepatitis A & Hepatitis B (Recombinant) Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Twinrix
Proper name
Hepatitis A & Hepatitis B (Recombinant) Vaccine
Licence type
351(a)
BLA number
103850
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
1ML Injection Intramuscular Single-Dose Vial Rx May 11, 2001

Sources for this page

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