Codeine sulfate

Hikma Pharmaceuticals USA Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 15, 2023
Approval ID: 010905f9-3bcb-4b50-9fe8-a3ad0010f14c
Products: 3 registered
Version: 24

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use CODEINE SULFATE TABLETS safely and effectively. See full prescribing information for CODEINE SULFATE TABLETS. CODEINE SULFATE tablets, for oral use CIIInitial U.S. Approval: 1950

Quick Stats

Total Products3

Labelers2

Label Sections21

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.