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# Augmentin Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/augmentin-not-withdrawn-due-to-safety-efficacy/
- Published: 2024-10-02T12:00:00.000Z
- Updated: 2026-09-14T14:42:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157902

*Federal Register* notice: FDA has determined that U.S. Antibiotics’ Augmentin XR (amoxicillin; clavulanate potassium) extended-release tablet, 1g; equivalent to 62.5mg base, was not withdrawn from sale for safety or effectiveness reasons. The determination will permit the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-10-02/pdf/2024-22572.pdf?ref=fdaweb.com).