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Tzield
teplizumab-mzwv
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tzield
Proper name
teplizumab-mzwv
Licence type
351(a)
BLA number
761183
Applicant
Provention Bio, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2MG/2ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | November 17, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 17, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |