| 药品名称 | LUPRON DEPOT | | 申请号 | 020517 | 产品号 | 003 | | 活性成分 | LEUPROLIDE ACETATE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 45MG/VIAL | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2011/06/17 | 申请机构 | ABBVIE ENDOCRINE INC
| | 化学类型 | New dosage form | 审评分类 | Standard review drug |
|
|
|
| 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 | | D-132 | 2014/06/17 | | NS | 2014/06/17 |
|
| 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 | | 020517 | 038 | AP | Letter | 2016/06/08 | 下载 | | 020517 | 038 | AP | Label | 2016/06/13 | 下载 | | 020517 | 036 | AP | Label | 2014/07/01 | 下载 | | 020517 | 036 | AP | Letter | 2014/07/01 | 下载 | | 020517 | 035 | AP | Label | 2013/07/11 | 下载 | | 020517 | 035 | AP | Letter | 2013/07/12 | 下载 | | 020517 | 033 | AP | Label | 2012/07/19 | 下载 | | 020517 | 033 | AP | Letter | 2012/07/20 | 下载 | | 020517 | 032 | AP | Letter | 2011/06/29 | 下载 | | 020517 | 032 | AP | Label | 2011/06/28 | 下载 | | 020517 | 032 | AP | Review | 2015/01/20 | 下载 | | 020517 | 031 | AP | Letter | 2011/01/20 | 下载 | | 020517 | 031 | AP | Label | 2011/01/20 | 下载 | | 020517 | 030 | AP | Review | 2015/01/20 | 下载 | | 020517 | 030 | AP | Label | 2011/06/28 | 下载 | | 020517 | 030 | AP | Letter | 2011/06/29 | 下载 | | 020517 | 029 | AP | Label | 2010/05/07 | 下载 | | 020517 | 029 | AP | Letter | 2010/05/04 | 下载 | | 020517 | 028 | AP | Letter | 2010/05/04 | 下载 | | 020517 | 028 | AP | Label | 2010/05/07 | 下载 | | 020517 | 025 | AP | Label | 2011/06/28 | 下载 | | 020517 | 025 | AP | Letter | 2011/06/29 | 下载 | | 020517 | 025 | AP | Review | 2015/01/20 | 下载 | | 020517 | 024 | AP | Letter | 2010/05/04 | 下载 | | 020517 | 024 | AP | Label | 2010/05/07 | 下载 | | 020517 | 019 | AP | Letter | 2005/10/20 | 下载 | | 020517 | 019 | AP | Review | 2007/07/09 | 下载 | | 020517 | 018 | AP | Review | 2007/07/09 | 下载 | | 020517 | 018 | AP | Letter | 2005/10/20 | 下载 | | 020517 | 016 | AP | Letter | 2004/01/14 | 下载 | | 020517 | 013 | AP | Letter | 2003/09/25 | 下载 | | 020517 | 006 | AP | Review | 2007/07/09 | 下载 | | 020517 | 002 | AP | Review | 1997/05/30 | 下载 | | 020517 | 001 | AP | Review | 2006/03/30 | 下载 | | 020517 | 000 | AP | Review | 2006/04/06 | 下载 | | 020517 | 000 | AP | Other Important Information from FDA | 2011/12/20 | 下载 |
|
| 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 | | 020517 | 038 | AP | 2016/06/06 | Labeling Revision | | 020517 | 037 | AP | 2016/02/11 | Manufacturing Change or Addition | | 020517 | 036 | AP | 2014/06/27 | Labeling Revision | | 020517 | 035 | AP | 2013/07/10 | Labeling Revision | | 020517 | 034 | AP | 2013/11/08 | Manufacturing Change or Addition | | 020517 | 033 | AP | 2012/07/18 | Labeling Revision | | 020517 | 032 | AP | 2011/06/17 | Labeling Revision | | 020517 | 031 | AP | 2011/01/14 | Labeling Revision | | 020517 | 030 | AP | 2011/06/17 | New Dosage Regimen | | 020517 | 029 | AP | 2010/04/28 | Labeling Revision | | 020517 | 028 | AP | 2010/04/28 | Labeling Revision | | 020517 | 025 | AP | 2011/06/17 | Labeling Revision | | 020517 | 024 | AP | 2010/04/28 | Labeling Revision | | 020517 | 019 | AP | 2005/09/15 | Labeling Revision | | 020517 | 018 | AP | 2005/09/15 | Control Supplement | | 020517 | 016 | AP | 2004/01/12 | Labeling Revision | | 020517 | 014 | AP | 2002/09/20 | Control Supplement | | 020517 | 013 | AP | 2003/09/09 | Labeling Revision | | 020517 | 012 | AP | 2002/05/23 | Control Supplement | | 020517 | 011 | AP | 2001/07/23 | Control Supplement | | 020517 | 010 | AP | 2001/03/01 | Labeling Revision | | 020517 | 009 | AP | 2001/01/24 | Control Supplement | | 020517 | 008 | AP | 2000/05/12 | Control Supplement | | 020517 | 007 | AP | 2000/05/11 | Control Supplement | | 020517 | 006 | AP | 1999/08/13 | Manufacturing Change or Addition | | 020517 | 005 | AP | 1998/07/29 | Control Supplement | | 020517 | 004 | AP | 1997/12/23 | Control Supplement | | 020517 | 002 | AP | 1997/05/30 | New Dosage Regimen | | 020517 | 001 | AP | 1996/12/03 | Package Change | | 020517 | 000 | AP | 1995/12/22 | Approval |
|