Promethazine Hydrochloride and Codeine Phosphate

Tris Pharma Inc🇺🇸 United States

FDA Page

Effective Date: Oct 5, 2023
Approval ID: 785c605e-1907-4fac-8b69-d504a2076f8e
Products: 1 registered
Version: 10

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

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

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.