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Menhibrix
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Menhibrix
Proper name
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Licence type
351(a)
BLA number
125363
Applicant
GlaxoSmithKline Biologicals
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5ML | Injection | Intramuscular | Vial | Disc | June 14, 2012 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |