Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 07/04/20221 min di lettura
Determination That PEPCID (Famotidine) for Oral Suspension, 40 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Riepilogo
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or we) has determined that PEPCID (famotidine) for oral suspension, 40 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →