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Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pentacel
Proper name
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Licence type
351(a)
BLA number
125145
Applicant
Sanofi Vaccines Canada Ltd.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | June 20, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |