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Negócios · 14/09/20101 min de leitura
Determination That VESANOID (Tretinoin) Capsules, 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA) has determined that VESANOID (tretinoin) Capsules, 10 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug application (ANDA) that refers to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Idioma original da fonte: Federal Register — Health and Human ServicesAbrir o comunicado original →