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Negocios · 21/10/20201 min de lectura
Determination That BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Resumen
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products if they meet relevant legal and regulatory requirements.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →