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Lymphir
denileukin diftitox-cxdl
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lymphir
Proper name
denileukin diftitox-cxdl
Licence type
351(a)
BLA number
761312
Applicant
Citius Oncology, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300MCG | For Injection | Intravenous | Single-Dose Vial | Rx | August 7, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |