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ビジネス · 2018/1/231 分で読めます

Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen

ローカル自動翻訳 · 情報源の原言語

概要

The Food and Drug Administration (FDA and Agency) is withdrawing approval of an abbreviated new drug application (ANDA), held by Watson Laboratories, Inc. (Watson), for prescription pain medications that contain more than 325 milligrams (mg) of acetaminophen. Watson has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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