Budesonide and Formoterol Fumarate Dihydrate

RPK Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 30, 2022
Approval ID: bbd0a8f7-d855-41cc-b6b0-70fe2f20d079
Products: 1 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation useInitial U.S. Approval: 2006

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.