Hydroxyurea

REMEDYREPACK INC.🇺🇸 United States

FDA Page

Effective Date: Feb 14, 2024
Approval ID: af9d68b3-c43e-44e5-bf7d-80dbc2edc53a
Products: 1 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HYDROXYUREA Capsules safely and effectively. See full prescribing information for HYDROXYUREA Capsules. HYDROXYUREA capsules, USP, for oral use Initial U.S. Approval: 1967 Warnings and Precautions, Pulmonary Toxicity (5.9) 7/2019

Quick Stats

Total Products1

Labelers2

Label Sections34

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.