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 · 2025/9/241 分で読めます
Approval of Previously Withdrawn New Drug Application for WELLCOVORIN (Leucovorin Calcium) Tablets
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The Food and Drug Administration (FDA or Agency) is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base. FDA is initiating this action on the basis of new data and is required to publish notice of approval of an NDA for which the Agency had previously withdrawn approval.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →