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Negócios · 11/06/20131 min de leitura
Determination That CORDRAN (Flurandrenolide) Ointment USP, 0.025% and 0.05%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Resumo
The Food and Drug Administration (FDA) has determined that CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for flurandrenolide ointment, 0.025% and 0.05%, if all other legal and regulatory requirements are met.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →