| 药品名称 | TRELSTAR | | 申请号 | 020715 | 产品号 | 001 | | 活性成分 | TRIPTORELIN PAMOATE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INTRAMUSCULAR | 规格 | EQ 3.75MG BASE/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2000/06/15 | 申请机构 | ALLERGAN SALES LLC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
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| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | 无 | | 历史市场独占权保护信息 | | 无 |
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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 | | 020715 | 032 | AP | Label | 2014/07/15 | 下载 | | 020715 | 032 | AP | Letter | 2014/07/15 | 下载 | | 020715 | 030 | AP | Letter | 2013/03/15 | 下载 | | 020715 | 030 | AP | Label | 2013/03/15 | 下载 | | 020715 | 025 | AP | Label | 2011/05/23 | 下载 | | 020715 | 025 | AP | Letter | 2011/05/24 | 下载 | | 020715 | 024 | AP | Letter | 2011/01/20 | 下载 | | 020715 | 024 | AP | Label | 2011/01/20 | 下载 | | 020715 | 016 | AP | Letter | 2008/04/16 | 下载 | | 020715 | 006 | AP | Letter | 2005/10/25 | 下载 | | 020715 | 004 | AP | Letter | 2002/01/15 | 下载 | | 020715 | 003 | AP | Letter | 2002/01/15 | 下载 | | 020715 | 000 | AP | Review | 2002/07/31 | 下载 | | 020715 | 000 | AP | Letter | 2000/06/15 | 下载 | | 020715 | 000 | AP | Label | 2000/06/15 | 下载 | | 020715 | 000 | AP | Other Important Information from FDA | 2011/12/20 | 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 | | 020715 | 035 | AP | 2016/08/15 | Manufacturing Change or Addition | | 020715 | 034 | AP | 2015/02/03 | Manufacturing Change or Addition | | 020715 | 033 | AP | 2014/07/15 | Manufacturing Change or Addition | | 020715 | 032 | AP | 2014/07/11 | Labeling Revision | | 020715 | 031 | AP | 2014/03/14 | Manufacturing Change or Addition | | 020715 | 030 | AP | 2013/03/12 | Labeling Revision | | 020715 | 029 | AP | 2013/06/19 | Manufacturing Change or Addition | | 020715 | 028 | AP | 2013/04/11 | Manufacturing Change or Addition | | 020715 | 027 | AP | 2013/04/25 | Manufacturing Change or Addition | | 020715 | 025 | AP | 2011/05/19 | Labeling Revision | | 020715 | 024 | AP | 2011/01/14 | Labeling Revision | | 020715 | 016 | AP | 2008/04/14 | Control Supplement | | 020715 | 006 | AP | 2005/10/20 | Labeling Revision | | 020715 | 004 | AP | 2002/01/15 | Labeling Revision | | 020715 | 003 | AP | 2002/01/15 | Labeling Revision | | 020715 | 002 | AP | 2001/06/20 | Control Supplement | | 020715 | 001 | AP | 2000/10/23 | Manufacturing Change or Addition | | 020715 | 000 | AP | 2000/06/15 | Approval |
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