On this page
Kisunla
donanemab-azbt
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kisunla
Proper name
donanemab-azbt
Licence type
351(a)
BLA number
761248
Applicant
Eli Lilly and Company
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 350MG/20ML (17.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | July 2, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |