Amoxicillin and Clavulanate Potassium

Denton Pharma, Inc. DBA Northwind Pharmaceuticals🇺🇸 United States

FDA Page

Effective Date: Nov 29, 2021
Approval ID: 6441558e-2d6c-b37d-e053-2991aa0adf50
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN and CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Quick Stats

Total Products1

Labelers2

Label Sections17

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.