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Dysport
abobotulinumtoxinA
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Dysport
Proper name
abobotulinumtoxinA
Licence type
351(a)
BLA number
125274
Applicant
Ipsen Biopharm Limited
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | April 29, 2009 |
| 500UNITS | For Injection | Intramuscular | Single-Dose Vial | Rx | April 29, 2009 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 29, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |