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Ontak
denileukin diftitox
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ontak
Proper name
denileukin diftitox
Licence type
351(a)
BLA number
103767
Applicant
Eisai, Incorporated
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MCG/ML (300MCG/2ML) | Injection | Intravenous | Single-Dose Vial | Disc | February 5, 1999 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 5, 2006 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |