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Product safetyFDAUnited StatesImports

Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

27 October 2026

In plain English

FDA has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not withdrawn for safety or effectiveness reasons, allowing approval of ANDAs for this drug.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
27 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness.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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