ABILIFY MAINTENA

Otsuka America Pharmaceutical, Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 24, 2026
Approval ID: ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6
Products: 4 registered
Version: 27

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ABILIFY MAINTENA safely and effectively. See full prescribing information for ABILIFY MAINTENA. ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension, for intramuscular use Initial U.S. Approval: 2002

Quick Stats

Total Products4

Labelers2

Label Sections47

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.