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Quadracel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Quadracel
Proper name
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Licence type
351(a)
BLA number
125525
Applicant
Sanofi Vaccines Canada Ltd.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5ML | Injection | Intramuscular | Single-Dose Vial | Disc | March 24, 2015 |
| 0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | January 25, 2022 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |