onabotulinumtoxinA

FDA Drug Profile — BOTOX Cosmetic, BOTOX

onabotulinumtoxinA is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including BOTOX Cosmetic, BOTOX. Available dosage form: injection, powder, lyophilized, for solution.

Drug Details

Generic Name
onabotulinumtoxinA
Brand Names
BOTOX Cosmetic, BOTOX
Application Number
BLA103000
Sponsor
Allergan, Inc.
NDC Codes
7
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR, INTRADERMAL
Active Ingredients
BOTULINUM TOXIN TYPE A

Indications and Usage

1 INDICATIONS AND USAGE BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: • moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity • moderate to severe lateral canthal lines associated with orbicularis oculi activity • moderate to severe forehead lines associated with frontalis muscle activity • moderate to severe platysma bands associated with platysma muscle activity BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of ( 1 ): Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity Moderate to severe lateral canthal lines associated with orbicularis oculi activity Moderate to severe forehead lines associated with frontalis muscle activity Moderate to severe platysma bands associated with platysma muscle activity