PHENYLEPHRINE HYDROCHLORIDE

Gland Pharma Limited🇺🇸 United States

FDA Page

Effective Date: Sep 18, 2025
Approval ID: 2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb
Products: 3 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP. PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%. Initial U.S. Approval: 1939

Quick Stats

Total Products3

Labelers1

Label Sections30

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.