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Imjudo
tremelimumab-actl
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Imjudo
Proper name
tremelimumab-actl
Licence type
351(a)
BLA number
761289
Applicant
AstraZeneca AB
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 25MG/1.25ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | October 21, 2022 |
| 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | October 21, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 21, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |