Determination That Periactin Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

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(FDA) has determined that Periactin (cyproheptadine hydrochloride (HCl)) 4-milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness.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.