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2026-10-27 · Notice · Federal Register document 2026-21897

Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Official abstract: The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for famotidine) orally disintegrating tablets, 20 mg and 40 mg, if all other legal and regulatory requirements are met.

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