本文翻译正在准备中。在此之前，我们暂时显示英文原文。
商业 · 2020/8/31 分钟阅读
Watson Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets
本地自动翻译 · 来源原始语言
摘要
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen 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 →