onabotulinumtoxinA
onabotulinumtoxinA is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including BOTOX, BOTOX Cosmetic. Available dosage form: injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- onabotulinumtoxinA
- Brand Names
- BOTOX, BOTOX Cosmetic
- Application Number
- BLA103000
- Sponsor
- Allergan, Inc.
- NDC Codes
- 7
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRADERMAL, INTRAMUSCULAR
- 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