FDA — authorised 28 February 2013
- Application: NDA202971
- Marketing authorisation holder: OTSUKA PHARM CO LTD
- Local brand name: ABILIFY MAINTENA KIT
- Indication: FOR SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
🇺🇸 Aripiprazole (Fixed dose) in United States
FDA authorised Aripiprazole (Fixed dose) on 28 February 2013
Marketing authorisations
FDA — authorised 28 April 2015
- Application: ANDA078608
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2015
- Application: ANDA202101
- Marketing authorisation holder: ALEMBIC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2015
- Application: ANDA201519
- Marketing authorisation holder: TORRENT
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2015
- Application: ANDA202102
- Marketing authorisation holder: ALEMBIC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 28 April 2015
- Application: ANDA078607
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2015
- Application: ANDA205064
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2015
- Application: ANDA078708
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2015
- Application: ANDA078583
- Marketing authorisation holder: APOTEX
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 August 2015
- Application: ANDA204171
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 September 2015
- Application: ANDA204094
- Marketing authorisation holder: APOTEX
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 June 2016
- Application: ANDA204838
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 2016
- Application: ANDA206383
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 October 2016
- Application: ANDA204111
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2016
- Application: ANDA206251
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2017
- Application: ANDA091279
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 2017
- Application: ANDA202683
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2017
- Application: NDA207202
- Marketing authorisation holder: OTSUKA
- Local brand name: ABILIFY MYCITE KIT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2017
- Application: ANDA205363
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2017
- Application: ANDA202547
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 18 April 2018
- Application: ANDA207240
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 28 August 2018
- Application: ANDA090165
- Marketing authorisation holder: SQUARE PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 19 September 2018
- Application: ANDA206240
- Marketing authorisation holder: RISING
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2019
- Application: ANDA090472
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 2019
- Application: ANDA210479
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 February 2019
- Application: ANDA207105
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2019
- Application: ANDA212870
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 1 December 2021
- Application: ANDA203025
- Marketing authorisation holder: UNICHEM
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2022
- Application: ANDA215595
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 April 2023
- Application: NDA217006
- Marketing authorisation holder: OTSUKA
- Local brand name: ABILIFY ASIMTUFII
- Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
FDA — authorised 1 November 2023
- Application: ANDA216150
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 March 2024
- Application: ANDA205589
- Marketing authorisation holder: LUPIN
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2024
- Application: NDA216655
- Marketing authorisation holder: XIAMEN LP PHARM CO
- Local brand name: OPIPZA
- Indication: FILM — ORAL
- Status: approved
FDA — authorised 3 December 2024
- Application: ANDA216608
- Marketing authorisation holder: MYLAN
- Local brand name: ARIPIPRAZOLE
- Indication: FOR SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
FDA — authorised 15 April 2025
- Application: NDA211448
- Marketing authorisation holder: CMG PHARM CO LTD
- Local brand name: MEZOFY
- Indication: FILM — ORAL
- Status: approved
FDA — authorised 22 October 2025
- Application: ANDA215582
- Marketing authorisation holder: QUAGEN
- Local brand name: ARIPIPRAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 February 2026
- Application: ANDA216208
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA
- Application: ANDA208260
- Marketing authorisation holder: PHARMTAK INC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078614
- Marketing authorisation holder: SUN PHARMA GLOBAL
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078613
- Marketing authorisation holder: BARR LABS INC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA208438
- Marketing authorisation holder: PHARMTAK INC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA
- Application: ANDA078612
- Marketing authorisation holder: BARR LABS INC
- Local brand name: ARIPIPRAZOLE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
Other Psychiatry approved in United States
Frequently asked questions
Is Aripiprazole (Fixed dose) approved in United States?
Yes. FDA authorised it on 28 February 2013; FDA authorised it on 28 April 2015; FDA authorised it on 28 April 2015.
Who is the marketing authorisation holder for Aripiprazole (Fixed dose) in United States?
OTSUKA PHARM CO LTD holds the US marketing authorisation.