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Menactra
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Menactra
Proper name
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Licence type
351(a)
BLA number
125089
Applicant
Sanofi Vaccines US Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 48UG/.5ML | For Injection | Intramuscular | Single-Dose Vial | Rx | January 14, 2005 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |