药品名称 | FASLODEX | 申请号 | 021344 | 产品号 | 001 | 活性成分 | FULVESTRANT | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INTRAMUSCULAR | 规格 | 50MG/ML | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2002/04/25 | 申请机构 | ASTRAZENECA PHARMACEUTICALS LP
| 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
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与药品注册相关的信息 | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | 021344 | 031 | AP | Letter | 2016/10/31 | 下载 | 021344 | 029 | AP | Letter | 2016/07/13 | 下载 | 021344 | 029 | AP | Label | 2016/07/13 | 下载 | 021344 | 027 | AP | Letter | 2016/05/20 | 下载 | 021344 | 027 | AP | Label | 2016/05/23 | 下载 | 021344 | 026 | AP | Letter | 2016/03/04 | 下载 | 021344 | 026 | AP | Label | 2016/03/04 | 下载 | 021344 | 025 | AP | Letter | 2016/03/03 | 下载 | 021344 | 025 | AP | Label | 2016/03/03 | 下载 | 021344 | 020 | AP | Letter | 2012/11/13 | 下载 | 021344 | 020 | AP | Label | 2012/11/08 | 下载 | 021344 | 019 | AP | Letter | 2012/11/13 | 下载 | 021344 | 019 | AP | Label | 2012/11/08 | 下载 | 021344 | 018 | AP | Letter | 2012/07/17 | 下载 | 021344 | 018 | AP | Label | 2012/07/25 | 下载 | 021344 | 015 | AP | Label | 2011/09/26 | 下载 | 021344 | 015 | AP | Letter | 2011/09/29 | 下载 | 021344 | 014 | AP | Label | 2011/09/26 | 下载 | 021344 | 014 | AP | Letter | 2011/09/29 | 下载 | 021344 | 013 | AP | Letter | 2011/05/19 | 下载 | 021344 | 013 | AP | Label | 2011/05/23 | 下载 | 021344 | 012 | AP | Letter | 2010/09/13 | 下载 | 021344 | 012 | AP | Label | 2010/09/10 | 下载 | 021344 | 007 | AP | Letter | 2010/09/13 | 下载 | 021344 | 007 | AP | Label | 2010/09/10 | 下载 | 021344 | 004 | AP | Letter | 2005/08/08 | 下载 | 021344 | 004 | AP | Label | 2005/08/08 | 下载 | 021344 | 001 | AP | Letter | 2004/01/14 | 下载 | 021344 | 001 | AP | Label | 2004/01/15 | 下载 | 021344 | 000 | AP | Letter | 2002/04/25 | 下载 | 021344 | 000 | AP | Label | 2002/04/25 | 下载 | 021344 | 000 | AP | Review | 2002/04/25 | 下载 |
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药品注册审批历史信息 | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | 021344 | 031 | AP | 2016/10/26 | Labeling Revision | 021344 | 030 | AP | 2014/06/30 | Manufacturing Change or Addition | 021344 | 029 | AP | 2016/07/12 | Labeling Revision | 021344 | 027 | AP | 2016/05/19 | Labeling Revision | 021344 | 026 | AP | 2016/03/02 | Efficacy Supplement with Clinical Data to Support | 021344 | 025 | AP | 2016/03/01 | Labeling Revision | 021344 | 024 | AP | 2014/08/25 | Manufacturing Change or Addition | 021344 | 022 | AP | 2013/10/08 | Manufacturing Change or Addition | 021344 | 021 | AP | 2013/10/08 | Manufacturing Change or Addition | 021344 | 020 | AP | 2012/11/09 | Efficacy Supplement with Clinical Data to Support | 021344 | 019 | AP | 2012/11/09 | Labeling Revision | 021344 | 018 | AP | 2012/07/13 | Labeling Revision | 021344 | 015 | AP | 2011/09/26 | Labeling Revision | 021344 | 014 | AP | 2011/09/26 | Labeling Revision | 021344 | 013 | AP | 2011/05/17 | Patient Population Altered | 021344 | 012 | AP | 2010/09/09 | New Dosage Regimen | 021344 | 007 | AP | 2010/09/09 | Labeling Revision | 021344 | 004 | AP | 2005/08/02 | Labeling Revision | 021344 | 001 | AP | 2003/12/24 | Efficacy Supplement with Clinical Data to Support | 021344 | 000 | AP | 2002/04/25 | Approval |
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