Dexmedetomidine Hydrochloride

Fresenius Kabi USA, LLC🇺🇸 United States

FDA Page

Effective Date: May 5, 2022
Approval ID: 4d5d2294-89a0-4b6f-aa00-d39a0393b6a8
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively.See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION.DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% Sodium Chloride Injection, for intravenous useInitial U.S. Approval: 1999

Quick Stats

Total Products1

Labelers2

Label Sections22

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.