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Recombivax, Recombivax Hb
Hepatitis B Vaccine (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Recombivax, Recombivax Hb
Proper name
Hepatitis B Vaccine (Recombinant)
Licence type
351(a)
BLA number
101066
Applicant
Merck Sharp & Dohme LLC
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | July 23, 1986 |
| 10UG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | February 26, 1996 |
| 40UG/ML | Injection | Intramuscular | Single-Dose Vial | Rx | July 23, 1986 |
| 5UG/0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | July 23, 1986 |
| 5UG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | February 26, 1996 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |