Ascomp with Codeine

LGM PHARMA SOLUTIONS, LLC🇺🇸 United States

FDA Page

Effective Date: Nov 1, 2025
Approval ID: 1cab3106-1064-4b42-892b-39f405d9e02f
Products: 1 registered
Version: 15

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990

Quick Stats

Total Products1

Labelers2

Label Sections20

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.