药品名称 | LOTENSIN | 申请号 | 019851 | 产品号 | 004 | 活性成分 | BENAZEPRIL HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 40MG | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1991/06/25 | 申请机构 | US PHARMACEUTICALS HOLDINGS I LLC
| 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
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与本品相关的专利信息(来自橙皮书Orange Book) | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | 无 | 历史专利信息 | 无 |
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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 | M-30 | 2007/03/02 | PED | 2007/09/02 |
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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 | 019851 | 049 | AP | Letter | 2015/07/23 | 下载 | 019851 | 049 | AP | Label | 2015/07/24 | 下载 | 019851 | 047 | AP | Letter | 2015/01/27 | 下载 | 019851 | 047 | AP | Label | 2015/01/30 | 下载 | 019851 | 046 | AP | Letter | 2014/12/15 | 下载 | 019851 | 046 | AP | Label | 2014/12/16 | 下载 | 019851 | 045 | AP | Letter | 2015/07/23 | 下载 | 019851 | 045 | AP | Label | 2015/07/24 | 下载 | 019851 | 044 | AP | Label | 2012/09/25 | 下载 | 019851 | 043 | AP | Label | 2012/01/23 | 下载 | 019851 | 043 | AP | Letter | 2012/02/06 | 下载 | 019851 | 042 | AP | Letter | 2012/05/21 | 下载 | 019851 | 042 | AP | Label | 2012/05/22 | 下载 | 019851 | 040 | AP | Letter | 2011/06/16 | 下载 | 019851 | 040 | AP | Label | 2011/06/16 | 下载 | 019851 | 038 | AP | Label | 2009/11/16 | 下载 | 019851 | 038 | AP | Letter | 2010/01/07 | 下载 | 019851 | 037 | AP | Letter | 2009/01/26 | 下载 | 019851 | 036 | AP | Letter | 2008/06/02 | 下载 | 019851 | 034 | AP | Letter | 2007/02/12 | 下载 | 019851 | 029 | AP | Letter | 2003/11/05 | 下载 | 019851 | 028 | AP | Letter | 2004/03/03 | 下载 | 019851 | 028 | AP | Label | 2004/04/05 | 下载 | 019851 | 000 | AP | Other Important Information from FDA | 2006/06/09 | 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 | 019851 | 050 | AP | 2015/12/17 | Manufacturing Change or Addition | 019851 | 049 | AP | 2015/07/22 | Labeling Revision | 019851 | 048 | AP | 2015/07/14 | Manufacturing Change or Addition | 019851 | 047 | AP | 2015/01/26 | Labeling Revision | 019851 | 046 | AP | 2014/12/12 | Labeling Revision | 019851 | 045 | AP | 2015/07/22 | Labeling Revision | 019851 | 044 | AP | 2012/09/21 | Labeling Revision | 019851 | 043 | AP | 2012/01/19 | Labeling Revision | 019851 | 042 | AP | 2012/05/17 | Labeling Revision | 019851 | 040 | AP | 2011/06/14 | Labeling Revision | 019851 | 038 | AP | 2009/11/10 | Labeling Revision | 019851 | 037 | AP | 2009/01/22 | Labeling Revision | 019851 | 036 | AP | 2008/05/29 | Labeling Revision | 019851 | 034 | AP | 2007/02/02 | Labeling Revision | 019851 | 029 | AP | 2003/10/29 | Labeling Revision | 019851 | 028 | AP | 2004/03/02 | Patient Population Altered | 019851 | 026 | AP | 2002/10/25 | Control Supplement | 019851 | 025 | AP | 2002/09/20 | Manufacturing Change or Addition | 019851 | 024 | AP | 2002/04/29 | Manufacturing Change or Addition | 019851 | 023 | AP | 2001/11/30 | Control Supplement | 019851 | 022 | AP | 2001/08/13 | Package Change | 019851 | 021 | AP | 2001/12/14 | Labeling Revision | 019851 | 020 | AP | 2000/11/02 | Manufacturing Change or Addition | 019851 | 019 | AP | 2000/05/10 | Manufacturing Change or Addition | 019851 | 018 | AP | 1999/04/28 | Package Change | 019851 | 017 | AP | 1998/07/20 | Control Supplement | 019851 | 016 | AP | 1998/07/29 | Labeling Revision | 019851 | 015 | AP | 1997/08/13 | Package Change | 019851 | 014 | AP | 1997/04/18 | Package Change | 019851 | 013 | AP | 1997/01/13 | Expiration Date Change | 019851 | 012 | AP | 1996/06/25 | Package Change | 019851 | 011 | AP | 1995/11/02 | Manufacturing Change or Addition | 019851 | 010 | AP | 1995/07/07 | Control Supplement | 019851 | 009 | AP | 1995/11/22 | Labeling Revision | 019851 | 008 | AP | 1995/02/08 | Control Supplement | 019851 | 007 | AP | 1995/05/05 | Labeling Revision | 019851 | 006 | AP | 1994/03/15 | Control Supplement | 019851 | 005 | AP | 1993/10/21 | Labeling Revision | 019851 | 004 | AP | 1992/11/20 | Labeling Revision | 019851 | 003 | AP | 1992/06/25 | Labeling Revision | 019851 | 002 | AP | 1992/03/13 | Package Change | 019851 | 001 | AP | 1992/01/09 | Labeling Revision | 019851 | 000 | AP | 1991/06/25 | Approval |
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