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Negocios · 4/6/20101 min de lectura

Determination That Cysteine Hydrochloride Injection, USP, 7.25%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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(FDA) is announcing its determination that Cysteine Hydrochloride Injection, USP, 7.25% (Cysteine HCl), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cysteine HCl if all other legal and regulatory requirements are met.

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