Application 761225
- Type
- BLA
- Sponsor
- HUGEL INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761225 | Letybo | letibotulinumtoxinA-wlbg | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LETYBO | LETIBOTULINUMTOXINA-WLBG | POWDER, FOR SOLUTION | 0.1ML(4UNITS) | 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 |
|---|---|---|---|---|---|---|
| LETYBO | LETIBOTULINUMTOXINA-WLBG | Hugel, Inc. | 910e5d0e-4d0b-4de8-8e2d-97879a044181 | 2024-11-18 | Boxed warning, Warnings, Adverse reactions | BLA761225 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.