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 · 2025/10/31 分で読めます
Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction
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概要
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on August 4, 2025 (90 FR 36440). The document announced the withdrawal of approval of 39 new drug applications (NDA) from multiple applicants, withdrawn as of September 3, 2025. The document erroneously included NDA number 021290. The correct NDA number is 020212 for Zinecard (dexrazoxane hydrochloric acid (HCl)) Injectable, equivalent to (EQ) 250 milligrams (mg) base/ vial and EQ 500 mg base/vial. This document corrects that error.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →