Naloxone Hydrochloride Injection, USP, Auto-Injector

Kaleo, Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 11, 2022
Approval ID: b5463553-b775-47a3-8d10-31e01ca1ec72
Products: 1 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use NALOXONE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for NALOXONE HYDROCHLORIDE INJECTION. NALOXONE HYDROCHLORIDE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1971

Quick Stats

Total Products1

Labelers2

Label Sections15

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.