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 · 2001/4/101 分で読めます
Parke-Davis Pharmaceutical Research et al.; Withdrawal of Approval of 14 New Drug Applications and 13 Abbreviated 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 of September 25, 1998 (63 FR 51359). The document announced the withdrawal of approval of 14 new drug applications and 13 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 80-025 for Sulf-10 (sulfacetamide sodium ophthalmic solution, USP) 10% held by Ciba Vision, 11460 Johns Creek Pkwy., Duluth, GA 30097-1556. FDA confirms that approval of ANDA 80-025 is still in effect.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →