On this page
Vaqta
Hepatitis A Vaccine Inactivated
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Vaqta
Proper name
Hepatitis A Vaccine Inactivated
Licence type
351(a)
BLA number
103606
Applicant
Merck Sharp & Dohme LLC
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 25U/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | March 29, 1996 |
| 25U/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | March 29, 1996 |
| 50U/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | March 29, 1996 |
| 50U/ML | Injection | Intramuscular | Single-Dose Vial | Rx | March 29, 1996 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |