Lisdexamfetamine dimesylate

Solco Healthcare US,LLC🇺🇸 United States

FDA Page

Effective Date: May 21, 2026
Approval ID: 68b10d9f-ca3e-493d-a309-45f1d7e08061
Products: 7 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use LISDEXAMFETAMINE DIMESYLATE CAPSULES safely and effectively. See full prescribing information for LISDEXAMFETAMINE DIMESYLATE CAPSULES.LISDEXAMFETAMINE DIMESYLATE capsules, for oral use, CII Initial U.S. Approval: 2007

Quick Stats

Total Products7

Labelers2

Label Sections45

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.