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Negócios · 02/03/20111 min de leitura
Determination That NILSTAT (Nystatin Powder (Oral, 100%)) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Resumo
The Food and Drug Administration (FDA) has determined that NILSTAT (nystatin powder (oral, 100%)) was not withdrawn from sale for reasons of safety or effectiveness.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.
Idioma original da fonte: Federal Register — Health and Human ServicesAbrir o comunicado original →