Abilify Maintena Kit

Treats schizophrenia. NDA 202971, held by Otsuka Pharm Co Ltd. Aripiprazole.

As of Nov 14, 2026, NDA 202971 (Abilify Maintena Kit), held by Otsuka Pharm Co Ltd, was first approved by FDA on Feb 28, 2013, with 16 approved supplements and 1 published complete response letter.

First approved: Feb 28, 2013
Review: Standard
Supplements approved: 16
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

ABILIFY MAINTENA (aripiprazole) is indicated: for the treatment of schizophrenia in adults for maintenance monotherapy treatment of bipolar I disorder in adults ABILIFY MAINTENA is an atypical antipsychotic indicated: for treatment of schizophrenia in adults for maintenance monotherapy treatment of bipolar I disorder in adults

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Mar 28, 2025	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter Medication Guide
Jul 27, 2017	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 29, 2015	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 5, 2014	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 28, 2013	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jul 26, 2012	ABILIFY MAINTENA (aripiprazole)Facility Inspections, Labeling, Carton And Immediate Container Labels	Approved

Products

4 strengths and forms


Abilify Maintena Kit300MG/VIAL · for suspension, extended release;intramuscular	Aripiprazole	RxReference drug
Abilify Maintena Kit400MG/VIAL · for suspension, extended release;intramuscular	Aripiprazole	RxReference drug
Abilify Maintena Kit300MG · for suspension, extended release;intramuscular	Aripiprazole	RxReference drug
Abilify Maintena Kit400MG · for suspension, extended release;intramuscular	Aripiprazole	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jan 28, 2026	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 28, 2025	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter Medication Guide
Mar 12, 2025	Supplement 17Manufacturing · Standard review	Approved	Letter Label
Jan 22, 2025	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 5, 2020	Supplement 13Labeling	Approved	Letter Label
Jul 27, 2017	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 11Labeling	Approved	Letter Label
Aug 18, 2016	Supplement 9Labeling	Approved	Label Letter
Mar 24, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 15, 2016	Supplement 8Labeling · Standard review	Approved	Label Letter
Jul 29, 2015	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 5, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 5, 2014	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 29, 2014	Supplement 4Manufacturing · Standard review	Approved	Label
Aug 15, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
May 30, 2014	Supplement 2Manufacturing · Standard review	Approved	Label
Feb 28, 2013	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 202971
Drugs@FDA: Overview at FDA
Company: Otsuka Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters