Product Details for: Botox Cosmetic

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intramuscular
50UNITS
Single-Dose Vial
351(a)
Botox Cosmetic
Rx
002
For Injection
Intramuscular
100UNITS
Single-Dose Vial
351(a)
Botox Cosmetic
Rx
003
For Injection
Injection, Intramuscular, Intradermal, Intradetrusor
50UNITS
Single-Dose Vial
351(a)
Botox
Disc
004
For Injection
Injection, Intramuscular, Intradermal, Intradetrusor
100UNITS
Single-Dose Vial
351(a)
Botox
Rx
005
For Injection
Injection, Intramuscular, Intradermal, Intradetrusor
200UNITS
Single-Dose Vial
351(a)
Botox
Rx
Proper Name
onabotulinumtoxinA
BLA Number
103000
Applicant
AbbVie Inc.
Original Approval Date
December 9, 1991
Date of First Licensure
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