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Xeomin

incobotulinumtoxinA

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Xeomin
Proper name
incobotulinumtoxinA
Licence type
351(a)
BLA number
125360
Applicant
Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals LLC
Center
CDER
Presentations
3
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
100UNITS For Injection Intramuscular, Intraglandular Single-Dose Vial Rx July 30, 2010
200UNITS For Injection Intramuscular, Intraglandular Single-Dose Vial Rx November 20, 2015
50UNITS For Injection Intramuscular, Intraglandular Single-Dose Vial Rx July 30, 2010

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity