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商业 · 2019/6/111 分钟阅读
Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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摘要
The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →