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商业 · 2020/7/131 分钟阅读
InvaGen Pharmaceuticals, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Trandolapril Tablets
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摘要
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for trandolapril tablets. The basis for the withdrawal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA. The holder of the ANDA 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 →