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Botox Cosmetic
onabotulinumtoxinA
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Botox Cosmetic
Proper name
onabotulinumtoxinA
Licence type
351(a)
BLA number
103000
Applicant
AbbVie 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 | December 9, 1991 |
| 50UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | December 9, 1991 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 20, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |