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Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Boostrix
Proper name
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Licence type
351(a)
BLA number
125106
Applicant
GlaxoSmithKline Biologicals
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2.5LF, 5LF, 2.5UG, 8UG UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | May 3, 2005 |
| 2.5LF, 5LF, 2.5UG, 8UG UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | May 3, 2005 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |