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 · 1998/6/51 分で読めます
KV Pharmaceutical Co.; Withdrawal of Approval of Two Abbreviated New Drug Applications and One Abbreviated Antibiotic Application
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 two abbreviated new drug applications (ANDA's) and one abbreviated antibiotic drug application (AADA) held by KV Pharmaceutical Co. (KV), 2503 South Hanley Rd., St. Louis, MO 63144. This action is being taken because the applications contain untrue statements of material fact, and the drugs covered by these applications lack substantial evidence of effectiveness.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →