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Lumoxiti
moxetumomab pasudotox-tdfk
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lumoxiti
Proper name
moxetumomab pasudotox-tdfk
Licence type
351(a)
BLA number
761104
Applicant
AstraZeneca AB
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1MG | For Injection | Intravenous | Single-Dose Vial | Disc | September 13, 2018 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 13, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |