FDA — authorised 15 November 2002
- Application: NDA021436
- Marketing authorisation holder: OTSUKA
- Local brand name: ABILIFY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Antidepressant + Aripiprazole in United States
FDA authorised Antidepressant + Aripiprazole on 15 November 2002
Marketing authorisations
FDA — authorised 10 December 2004
- Application: NDA021713
- Marketing authorisation holder: OTSUKA
- Local brand name: ABILIFY
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 June 2006
- Application: NDA021729
- Marketing authorisation holder: OTSUKA
- Local brand name: ABILIFY
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 20 September 2006
- Application: NDA021866
- Marketing authorisation holder: OTSUKA
- Local brand name: ABILIFY
- Indication: INJECTABLE — INTRAMUSCULAR
- Status: approved
Frequently asked questions
Is Antidepressant + Aripiprazole approved in United States?
Yes. FDA authorised it on 15 November 2002; FDA authorised it on 10 December 2004; FDA authorised it on 7 June 2006.
Who is the marketing authorisation holder for Antidepressant + Aripiprazole in United States?
OTSUKA holds the US marketing authorisation.