| 药品名称 | LUPRON DEPOT | | 申请号 | 020011 | 产品号 | 001 | | 活性成分 | LEUPROLIDE ACETATE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1990/10/22 | 申请机构 | ABBVIE ENDOCRINE INC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 | | 020011 | 041 | AP | Letter | 2013/10/31 | 下载 | | 020011 | 041 | AP | Label | 2013/11/05 | 下载 | | 020011 | 040 | AP | Label | 2012/01/23 | 下载 | | 020011 | 040 | AP | Letter | 2012/01/25 | 下载 | | 020011 | 039 | AP | Label | 2011/06/16 | 下载 | | 020011 | 039 | AP | Letter | 2011/06/16 | 下载 | | 020011 | 038 | AP | Label | 2012/03/28 | 下载 | | 020011 | 038 | AP | Letter | 2012/04/02 | 下载 | | 020011 | 037 | AP | Label | 2010/10/29 | 下载 | | 020011 | 037 | AP | Letter | 2010/11/02 | 下载 | | 020011 | 036 | AP | Label | 2009/06/04 | 下载 | | 020011 | 036 | AP | Letter | 2009/06/08 | 下载 | | 020011 | 033 | AP | Letter | 2007/11/08 | 下载 | | 020011 | 031 | AP | Letter | 2005/10/20 | 下载 | | 020011 | 029 | AP | Letter | 2005/10/20 | 下载 | | 020011 | 028 | AP | Letter | 2004/01/14 | 下载 | | 020011 | 025 | AP | Letter | 2004/01/22 | 下载 | | 020011 | 021 | AP | Letter | 2001/09/21 | 下载 | | 020011 | 021 | AP | Label | 2001/09/21 | 下载 | | 020011 | 021 | AP | Review | 2001/11/14 | 下载 | | 020011 | 014 | AP | Letter | 1998/04/09 | 下载 | | 020011 | 014 | AP | Review | 2001/08/06 | 下载 | | 020011 | 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 | | 020011 | 041 | AP | 2013/10/30 | Labeling Revision | | 020011 | 040 | AP | 2012/01/23 | Labeling Revision | | 020011 | 039 | AP | 2011/06/14 | Labeling Revision | | 020011 | 038 | AP | 2012/03/28 | Labeling Revision | | 020011 | 037 | AP | 2010/10/29 | Labeling Revision | | 020011 | 036 | AP | 2009/06/02 | Labeling Revision | | 020011 | 033 | AP | 2007/10/31 | Labeling Revision | | 020011 | 031 | AP | 2005/09/15 | Labeling Revision | | 020011 | 029 | AP | 2005/09/15 | Control Supplement | | 020011 | 028 | AP | 2004/01/12 | Labeling Revision | | 020011 | 026 | AP | 2002/09/20 | Control Supplement | | 020011 | 025 | AP | 2004/01/15 | Labeling Revision | | 020011 | 024 | AP | 2002/05/23 | Control Supplement | | 020011 | 023 | AP | 2002/02/21 | Control Supplement | | 020011 | 022 | AP | 2001/11/14 | Labeling Revision | | 020011 | 021 | AP | 2001/09/21 | New or Modified Indication | | 020011 | 020 | AP | 2001/03/01 | Labeling Revision | | 020011 | 019 | AP | 2001/01/24 | Control Supplement | | 020011 | 018 | AP | 2000/05/12 | Control Supplement | | 020011 | 017 | AP | 2000/05/11 | Control Supplement | | 020011 | 016 | AP | 1999/08/13 | Manufacturing Change or Addition | | 020011 | 015 | AP | 1998/06/30 | Control Supplement | | 020011 | 014 | AP | 1998/04/09 | New or Modified Indication | | 020011 | 011 | AP | 1997/06/27 | Control Supplement | | 020011 | 010 | AP | 1996/09/12 | Labeling Revision | | 020011 | 008 | AP | 1995/08/11 | Control Supplement | | 020011 | 007 | AP | 1995/09/22 | Manufacturing Change or Addition | | 020011 | 006 | AP | 1995/10/26 | Package Change | | 020011 | 005 | AP | 1994/07/21 | Labeling Revision | | 020011 | 004 | AP | 1994/11/07 | Control Supplement | | 020011 | 003 | AP | 1994/02/14 | Expiration Date Change | | 020011 | 002 | AP | 1994/04/26 | Labeling Revision | | 020011 | 000 | AP | 1990/10/22 | Approval |
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