budesonide

Oceanside Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Apr 2, 2020
Approval ID: a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BUDESONIDE Extended-Release Tablets safely and effectively. See full prescribing information for BUDESONIDE Extended-Release Tablets. BUDESONIDE extended-release tablets, for oral use Initial U.S. Approval: 1997

Quick Stats

Total Products1

Labelers2

Label Sections18

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.