药品名称 | LUPRON DEPOT | 申请号 | 020708 | 产品号 | 001 | 活性成分 | LEUPROLIDE ACETATE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 11.25MG/VIAL | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1997/03/07 | 申请机构 | ABBVIE ENDOCRINE INC
| 化学类型 | New dosage form | 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 | 020708 | 034 | AP | Letter | 2013/10/31 | 下载 | 020708 | 034 | AP | Label | 2013/11/05 | 下载 | 020708 | 033 | AP | Label | 2012/01/23 | 下载 | 020708 | 033 | AP | Letter | 2012/01/25 | 下载 | 020708 | 032 | AP | Letter | 2011/06/16 | 下载 | 020708 | 032 | AP | Label | 2011/06/16 | 下载 | 020708 | 031 | AP | Label | 2012/03/28 | 下载 | 020708 | 031 | AP | Letter | 2012/04/02 | 下载 | 020708 | 030 | AP | Label | 2010/10/29 | 下载 | 020708 | 030 | AP | Letter | 2010/11/02 | 下载 | 020708 | 029 | AP | Label | 2009/06/04 | 下载 | 020708 | 029 | AP | Letter | 2009/06/08 | 下载 | 020708 | 026 | AP | Letter | 2007/11/08 | 下载 | 020708 | 021 | AP | Letter | 2005/10/20 | 下载 | 020708 | 021 | AP | Review | 2007/07/09 | 下载 | 020708 | 020 | AP | Review | 2007/07/09 | 下载 | 020708 | 020 | AP | Letter | 2005/10/20 | 下载 | 020708 | 018 | AP | Letter | 2004/01/14 | 下载 | 020708 | 015 | AP | Letter | 2004/01/22 | 下载 | 020708 | 011 | AP | Letter | 2001/09/21 | 下载 | 020708 | 011 | AP | Review | 2001/11/14 | 下载 | 020708 | 011 | AP | Label | 2001/09/21 | 下载 | 020708 | 006 | AP | Review | 2007/07/09 | 下载 | 020708 | 005 | AP | Review | 1999/06/22 | 下载 | 020708 | 005 | AP | Letter | 1999/02/11 | 下载 | 020708 | 003 | AP | Review | 2001/08/06 | 下载 | 020708 | 003 | AP | Letter | 1998/04/09 | 下载 | 020708 | 000 | AP | Review | 2003/08/08 | 下载 | 020708 | 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 | 020708 | 034 | AP | 2013/10/30 | Labeling Revision | 020708 | 033 | AP | 2012/01/23 | Labeling Revision | 020708 | 032 | AP | 2011/06/14 | Labeling Revision | 020708 | 031 | AP | 2012/03/28 | Labeling Revision | 020708 | 030 | AP | 2010/10/29 | Labeling Revision | 020708 | 029 | AP | 2009/06/02 | Labeling Revision | 020708 | 026 | AP | 2007/10/31 | Labeling Revision | 020708 | 021 | AP | 2005/09/15 | Labeling Revision | 020708 | 020 | AP | 2005/09/15 | Control Supplement | 020708 | 018 | AP | 2004/01/12 | Labeling Revision | 020708 | 016 | AP | 2002/09/20 | Control Supplement | 020708 | 015 | AP | 2004/01/15 | Labeling Revision | 020708 | 014 | AP | 2002/05/23 | Control Supplement | 020708 | 013 | AP | 2001/11/14 | Labeling Revision | 020708 | 012 | AP | 2001/07/23 | Control Supplement | 020708 | 011 | AP | 2001/09/21 | New or Modified Indication | 020708 | 010 | AP | 2001/03/01 | Labeling Revision | 020708 | 009 | AP | 2001/01/24 | Control Supplement | 020708 | 008 | AP | 2000/05/12 | Control Supplement | 020708 | 007 | AP | 2000/05/11 | Control Supplement | 020708 | 006 | AP | 1999/08/13 | Manufacturing Change or Addition | 020708 | 005 | AP | 1999/02/11 | Efficacy Supplement with Clinical Data to Support | 020708 | 004 | AP | 1998/07/29 | Control Supplement | 020708 | 003 | AP | 1998/04/09 | Labeling Revision | 020708 | 002 | AP | 1997/12/23 | Control Supplement | 020708 | 001 | AP | 1997/09/04 | Labeling Revision | 020708 | 000 | AP | 1997/03/07 | Approval |
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