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 · 2020/12/231 分で読めます
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for OPANA (oxymorphone hydrochloride) extended-release (ER) tablets (NDA 201655), held by Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355 (Endo). Endo requested that the approval of this application be withdrawn and has waived its opportunity for a hearing.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 →