Product Details for: Xeomin
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intramuscular, Intraglandular
50UNITS
Single-Dose Vial
351(a)
Xeomin
Rx
002
For Injection
Intramuscular, Intraglandular
100UNITS
Single-Dose Vial
351(a)
Xeomin
Rx
003
For Injection
Intramuscular, Intraglandular
200UNITS
Single-Dose Vial
351(a)
Xeomin
Rx
Proper Name
incobotulinumtoxinA
incobotulinumtoxinA
BLA Number
125360
125360
Applicant
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC
Original Approval Date
July 30, 2010
July 30, 2010
Date of First Licensure