Determination That PEPCID (Famotidine) for Oral Suspension, 40 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID (famotidine) for oral suspension, 40 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PEPCID (famotidine) for oral suspension, 40 mg/5 mL, if all other legal and regulatory requirements are met.