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Botox

onabotulinumtoxinA

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Botox
Proper name
onabotulinumtoxinA
Licence type
351(a)
BLA number
103000
Applicant
AbbVie Inc.
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 Injection, Intramuscular, Intradermal, Intradetrusor Single-Dose Vial Rx December 9, 1991
200UNITS For Injection Injection, Intramuscular, Intradermal, Intradetrusor Single-Dose Vial Rx December 9, 1991
50UNITS For Injection Injection, Intramuscular, Intradermal, Intradetrusor Single-Dose Vial Disc December 9, 1991

Exclusivity

Source: Purple Book
Kind Expires
Orphan exclusivityJune 20, 2026

Sources for this page

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