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
Impax Laboratories, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Ursodiol Capsules USP, 300 Milligrams
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of abbreviated new drug application (ANDA) 077895 for Ursodiol Capsules USP, 300 milligrams (mg), held by Impax Laboratories, LLC (Impax). Impax requested withdrawal of this application and has waived its opportunity for a hearing.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →