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 · 2017/8/161 分で読めます
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for ZALEPLON
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for ZALEPLON Capsules, 5 milligrams (mg) and 10 mg, held by Upsher-Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.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 →