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 · 2016/10/181 分で読めます
Mallinckrodt Pharmaceuticals; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →