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Negocios · 9/3/20101 min de lectura

Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Resumen

The Food and Drug Administration (FDA) is announcing its determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcipotriene Ointment, 0.005%, if all other legal and regulatory requirements are met.

Idioma original de la fuente: Federal Register — Health and Human ServicesAbrir el comunicado original →