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Varivax
Varicella Virus Vaccine Live
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Varivax
Proper name
Varicella Virus Vaccine Live
Licence type
351(a)
BLA number
103552
Applicant
Merck Sharp & Dohme LLC
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| NLT 1350PFU/.5ML | For Injection | Subcutaneous | Single-Dose Vial | Rx | March 17, 1995 |
| NLT 1350PFU/.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | February 27, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |