Application 761248
- Type
- BLA
- Sponsor
- ELI LILLY CO
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761248 | Kisunla | donanemab-azbt | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KISUNLA | DONANEMAB-AZBT | INJECTABLE;INJECTION | 350MG/20ML(17.5MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Kisunla | DONANEMAB-AZBT | Eli Lilly and Company | 190352d4-ef62-4679-b4fa-e846e2766afa | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | BLA761248 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.