Xopenex

Akorn🇺🇸 United States

FDA Page

Effective Date: Sep 14, 2022
Approval ID: 0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69
Products: 1 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XOPENEX Inhalation Solution Concentrate safely and effectively. See full prescribing information for XOPENEX Inhalation Solution Concentrate. XOPENEX (levalbuterol hydrochloride) Inhalation Solution ConcentrateInitial U.S. Approval: 1999

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.