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Zevalin
ibritumomab tiuxetan
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zevalin
Proper name
ibritumomab tiuxetan
Licence type
351(a)
BLA number
125019
Applicant
Acrotech Biopharma Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 3.2MG/2ML | Injection | Intravenous | Single-Dose Vial | Rx | February 19, 2002 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 19, 2009 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |