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Entreprise · 25/01/20081 min de lecture
Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Résumé
The Food and Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for quetiapine fumarate tablets, 150 mg, if all other legal and regulatory requirements are met.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →