Product Details for: Myobloc
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular, Intraglandular
2,500UNITS/0.5ML
Single-Dose Vial
351(a)
Myobloc
Rx
002
Injection
Intramuscular, Intraglandular
5,000UNITS/ML
Single-Dose Vial
351(a)
Myobloc
Rx
003
Injection
Intramuscular, Intraglandular
10,000UNITS/2ML (5,000UNITS/ML)
Single-Dose Vial
351(a)
Myobloc
Rx
Proper Name
rimabotulinumtoxinB
rimabotulinumtoxinB
BLA Number
103846
103846
Applicant
Solstice NeuroSciences, LLC
Solstice NeuroSciences, LLC
Original Approval Date
December 8, 2000
December 8, 2000
Date of First Licensure