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Engerix-B
Hepatitis B Vaccine (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Engerix-B
Proper name
Hepatitis B Vaccine (Recombinant)
Licence type
351(a)
BLA number
103239
Applicant
GlaxoSmithKline Biologicals
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | August 28, 1989 |
| 10UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | August 28, 1989 |
| 20UG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | August 28, 1989 |
| 20UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | August 28, 1989 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |