补充批准 · 说明书变更
批准信：Prior Approval；更新 XEPI (ozenoxacin) Cream 1% 的处方信息（不良事件联系方式）、包装标签（美国分销商变更为 Cutanea Life Sciences, Inc.）及 HOW SUPPLIED/STORAGE AND HANDLING 章节。
展开审批详情
批准信原文要点
This Prior Approval supplemental new drug application proposes the following changes: Change in contact information for SUSPECTED ADVERSE REACTIONS in HIGHLIGHT OF PRESCRIBING INFORMATIION; Changes in package insert and container labeling to reflect the change in US distributor from Medimetriks Pharmaceuticals, Inc. to Cutanea Life Sciences, Inc.; Changes to HOW SUPPLIED/STORAGE AND HANDLING Section (16).
Labeling-Container/Carton Labels；Labeling-Package Insert（CONT/CARTON；PI）
申报事项：说明书/标签变更（Prior Approval）
变更信息：更新 XEPI (ozenoxacin) Cream 1% 的处方信息（不良事件联系方式）、包装标签（美国分销商变更为 Cutanea Life Sciences, Inc.）及 HOW SUPPLIED/STORAGE AND HANDLING 章节。
来源：官方文件