Promethazine HCl, Phenylephrine HCl, Codeine Phosphate

Amneal Pharmaceuticals LLC🇺🇸 United States

FDA Page

Effective Date: Jan 12, 2024
Approval ID: 5f23b254-872b-4e88-91be-710c3ea7687b
Products: 1 registered
Version: 30

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PROMETHAZINE HCL, PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL, PHENYLEPHRINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL, PHENYLEPHRINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952

Quick Stats

Total Products1

Labelers2

Label Sections35

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.