药品名称 | LUPRON DEPOT | 申请号 | 019732 | 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 | 7.5MG/VIAL | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1989/01/26 | 申请机构 | ABBVIE ENDOCRINE INC
| 化学类型 | New dosage form | 审评分类 | Priority 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 | 019732 | 042 | AP | Letter | 2016/06/08 | 下载 | 019732 | 042 | AP | Label | 2016/06/13 | 下载 | 019732 | 041 | AP | Label | 2014/07/01 | 下载 | 019732 | 041 | AP | Letter | 2014/07/01 | 下载 | 019732 | 040 | AP | Label | 2013/07/11 | 下载 | 019732 | 040 | AP | Letter | 2013/07/12 | 下载 | 019732 | 038 | AP | Label | 2012/02/22 | 下载 | 019732 | 038 | AP | Letter | 2012/02/23 | 下载 | 019732 | 037 | AP | Letter | 2011/01/20 | 下载 | 019732 | 037 | AP | Label | 2011/01/20 | 下载 | 019732 | 036 | AP | Label | 2010/05/07 | 下载 | 019732 | 036 | AP | Letter | 2010/05/04 | 下载 | 019732 | 035 | AP | Letter | 2010/05/04 | 下载 | 019732 | 035 | AP | Label | 2010/05/07 | 下载 | 019732 | 031 | AP | Label | 2010/05/07 | 下载 | 019732 | 031 | AP | Letter | 2010/05/04 | 下载 | 019732 | 029 | AP | Review | 2006/10/26 | 下载 | 019732 | 029 | AP | Letter | 2005/10/20 | 下载 | 019732 | 027 | AP | Letter | 2005/10/20 | 下载 | 019732 | 027 | AP | Review | 2006/10/26 | 下载 | 019732 | 026 | AP | Letter | 2004/01/14 | 下载 | 019732 | 023 | AP | Letter | 2003/09/25 | 下载 | 019732 | 016 | AP | Review | 2006/10/26 | 下载 | 019732 | 012 | AP | Review | 2003/05/30 | 下载 | 019732 | 012 | AP | Letter | 2003/05/30 | 下载 | 019732 | 012 | AP | Label | 2003/05/30 | 下载 | 019732 | 009 | AP | Review | 2006/10/26 | 下载 | 019732 | 007 | AP | Review | 2006/10/26 | 下载 | 019732 | 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 | 019732 | 042 | AP | 2016/06/06 | Labeling Revision | 019732 | 041 | AP | 2014/06/27 | Labeling Revision | 019732 | 040 | AP | 2013/07/10 | Labeling Revision | 019732 | 038 | AP | 2012/02/17 | Labeling Revision | 019732 | 037 | AP | 2011/01/14 | Labeling Revision | 019732 | 036 | AP | 2010/04/28 | Labeling Revision | 019732 | 035 | AP | 2010/04/28 | Labeling Revision | 019732 | 031 | AP | 2010/04/28 | Labeling Revision | 019732 | 029 | AP | 2005/09/15 | Labeling Revision | 019732 | 027 | AP | 2005/09/15 | Control Supplement | 019732 | 026 | AP | 2004/01/12 | Labeling Revision | 019732 | 024 | AP | 2002/09/20 | Control Supplement | 019732 | 023 | AP | 2003/09/09 | Labeling Revision | 019732 | 022 | AP | 2002/05/23 | Control Supplement | 019732 | 021 | AP | 2002/02/21 | Control Supplement | 019732 | 020 | AP | 2001/03/01 | Labeling Revision | 019732 | 019 | AP | 2001/01/24 | Control Supplement | 019732 | 018 | AP | 2000/05/12 | Control Supplement | 019732 | 017 | AP | 2000/05/11 | Control Supplement | 019732 | 016 | AP | 1999/08/13 | Manufacturing Change or Addition | 019732 | 015 | AP | 1999/10/04 | Labeling Revision | 019732 | 014 | AP | 1998/06/30 | Control Supplement | 019732 | 013 | AP | 1997/06/27 | Control Supplement | 019732 | 012 | AP | 1998/01/09 | Labeling Revision | 019732 | 011 | AP | 1995/08/11 | Control Supplement | 019732 | 010 | AP | 1995/09/22 | Manufacturing Change or Addition | 019732 | 009 | AP | 1995/10/26 | Package Change | 019732 | 008 | AP | 1994/11/08 | Control Supplement | 019732 | 007 | AP | 1994/02/14 | Expiration Date Change | 019732 | 006 | AP | 1994/04/26 | Labeling Revision | 019732 | 003 | AP | 1992/03/26 | Manufacturing Change or Addition | 019732 | 002 | AP | 1990/12/14 | Control Supplement | 019732 | 000 | AP | 1989/01/26 | Approval |
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