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 · 2022/7/111 分で読めます
Xellia Pharmaceuticals USA, LLC; Withdrawal of Approval of an Abbreviated New Drug Application for Bacitracin for Injection
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is withdrawing the approval of an abbreviated new drug application (ANDA) for bacitracin for injection, 50,000 units/vial (ANDA 203177), held by Xellia Pharmaceuticals USA, LLC (Xellia). Xellia has requested withdrawal of approval 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 →