METHADOSE DISPERSIBLE

SpecGx LLC🇺🇸 United States

FDA Page

Effective Date: Aug 4, 2026
Approval ID: 544483e6-6f9d-4371-9e93-313e54e0ea05
Products: 2 registered
Version: 36

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use METHADOSE DISPERSIBLE TABLETS and METHADONE HYDROCHLORIDE TABLETS for oral suspension safely and effectively. See full prescribing information for METHADOSE DISPERSIBLE TABLETS and METHADONE HYDROCHLORIDE TABLETS for oral suspension. METHADOSE (methadone hydrochloride), dispersible tablets, for oral suspension, CII METHADONE HYDROCHLORIDE tablets for oral suspension, CII Initial U.S. Approval: 1947

Quick Stats

Total Products2

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.