この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2014/6/161 分で読めます
Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 milliliter (mL), 10 mL total fill volume, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, 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 →