ARISTADA INITIO

Alkermes, Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 1, 2023
Approval ID: b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403
Products: 1 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ARISTADA INITIO safely and effectively. See full prescribing information for ARISTADA INITIO.ARISTADA INITIO (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular useInitial U.S. Approval: 2015

Quick Stats

Total Products1

Labelers2

Label Sections18

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.