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商业 · 2019/7/101 分钟阅读
Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
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摘要
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →