Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

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and Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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.