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Determination That Periactin Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Zusammenfassung
The Food and Drug Administration (FDA) has determined that Periactin (cyproheptadine hydrochloride (HCl)) 4-milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cyproheptadine HCl 4-mg tablets.