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Myobloc
rimabotulinumtoxinB
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Myobloc
Proper name
rimabotulinumtoxinB
Licence type
351(a)
BLA number
103846
Applicant
Solstice NeuroSciences, LLC
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10,000UNITS/2ML (5,000UNITS/ML) | Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | December 8, 2000 |
| 2,500UNITS/0.5ML | Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | December 8, 2000 |
| 5,000UNITS/ML | Injection | Intramuscular, Intraglandular | Single-Dose Vial | Rx | December 8, 2000 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 8, 2007 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |