Fioricet with Codeine

Actavis Pharma, Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 1, 2021
Approval ID: df9801fc-03fe-41da-a6b3-0f76788217c9
Products: 1 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 FIORICET with CODEINE safely and effectively. See full prescribing information for FIORICET with CODEINE. FIORICET with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules, for oral use, CIII Initial U.S. Approval: 1992

Quick Stats

Total Products1

Labelers2

Label Sections19

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.