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FDA NDA · NDA202971

ABILIFY MAINTENA

aripiprazole

Sponsor: OTSUKA PHARM CO LTD

APPLICATION
NDA202971
TYPE
NDA
ORIGINAL APPROVAL
2013-02-28
LATEST ACTION
2026-01-28
ROUTE
INTRAMUSCULAR
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ABILIFY MAINTENA KIT · ReferencePrescription
ARIPIPRAZOLE 400MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ABILIFY MAINTENA KIT · ReferencePrescription
ARIPIPRAZOLE 400MG/VIAL · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ABILIFY MAINTENA KIT · ReferencePrescription
ARIPIPRAZOLE 300MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ABILIFY MAINTENA KIT · ReferencePrescription
ARIPIPRAZOLE 300MG/VIAL · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2026-01-28Labeling · Supplement 20 · standard — Letter ↗AP
2025-03-28Efficacy · Supplement 18 · standard — Label ↗AP
2025-03-12Manufacturing (CMC) · Supplement 17 · standard — Label ↗AP
2025-01-22Labeling · Supplement 19 · standard — Label ↗AP
2020-02-05Labeling · Supplement 13 · 901 required — Letter ↗AP
2017-07-27Efficacy · Supplement 10 · standard — Label ↗AP
2017-02-23Labeling · Supplement 11 · 901 required — Label ↗AP
2016-08-18Labeling · Supplement 9 · 901 required — Label ↗AP
2016-03-24Manufacturing (CMC) · Supplement 7 · standardAP
2016-01-15Labeling · Supplement 8 · standard — Letter ↗AP
2015-07-29Efficacy · Supplement 6 · standard — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 5 · standardAP
2014-12-05Efficacy · Supplement 3 · standard — Review ↗AP
2014-09-29Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2014-08-15Manufacturing (CMC) · Supplement 1 · standardAP
2014-05-30Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2013-02-28Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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