Ascomp with Codeine

Breckenridge Pharmaceutical, Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 18, 2024
Approval ID: 243a6aea-0f48-42a9-a85e-ff247ab94336
Products: 1 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990

Quick Stats

Total Products1

Labelers2

Label Sections39

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.