Determination That AUGMENTIN XR (Amoxicillin; Clavulanate Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA, Agency, or we) has determined that AUGMENTIN XR (amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gram (gm); equivalent to (EQ) 62.5 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for AUGMENTIN XR (amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gm; EQ 62.5 mg base, if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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