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Bexxar
tositumomab and iodine I-131 tositumomab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Bexxar
Proper name
tositumomab and iodine I-131 tositumomab
Licence type
351(a)
BLA number
125011
Applicant
GlaxoSmithKline LLC
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 225MG | Injection | Intravenous | Single-Dose Vial | Disc | June 27, 2003 |
| 35MG | Injection | Intravenous | Single-Dose Vial | Disc | June 27, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |