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 · 2014/4/21 分钟阅读
Determination That PREZISTA (Darunavir) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
本地自动翻译 · 来源原始语言
摘要
The Food and Drug Administration (FDA or the Agency) has determined that PREZISTA (darunavir) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for darunavir tablets, 400 mg, if all other legal and regulatory requirements are met.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →