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 · 2019/9/161 分で読めます
Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 5, 2019. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, effective March 7, 2019. The document erroneously included ANDA 077895 for Ursodiol Capsules USP, 300 milligrams, held by Impax Laboratories, LLC. This notice corrects that error.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →