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ビジネス · 2008/1/251 分で読めます

Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

ローカル自動翻訳 · 情報源の原言語

概要

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Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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