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商业 · 2021/10/221 分钟阅读
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications
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摘要
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →