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Letybo
letibotulinumtoxinA-wlbg
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Letybo
Proper name
letibotulinumtoxinA-wlbg
Licence type
351(a)
BLA number
761225
Applicant
Hugel, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | February 29, 2024 |
| 50UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | February 29, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |