ARTICAINE

NDC, Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 6, 2024
Approval ID: 0b0cbbec-8216-434f-892e-226c89d7239c
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use Articaine HCl and Epinephrine safely and effectively. See full prescribing information for Articaine HCl and Epinephrine. Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use Initial U.S. Approval: 2000

Quick Stats

Total Products1

Labelers2

Label Sections38

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.