Determination That NILSTAT (Nystatin Powder (Oral, 100%)) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) has determined that NILSTAT (nystatin powder (oral, 100%)) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nystatin powder (oral, 100%) if all other legal and regulatory requirements are met.