| 药品名称 | NITROLINGUAL PUMPSPRAY | | 申请号 | 018705 | 产品号 | 002 | | 活性成分 | NITROGLYCERIN | 市场状态 | 处方药 | | 剂型或给药途径 | SPRAY, METERED;SUBLINGUAL | 规格 | 0.4MG/SPRAY | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1997/01/10 | 申请机构 | POHL BOSKAMP
| | 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 | | 018705 | 019 | AP | Letter | 2015/01/26 | 下载 | | 018705 | 019 | AP | Label | 2015/01/30 | 下载 | | 018705 | 017 | AP | Letter | 2008/10/06 | 下载 | | 018705 | 017 | AP | Label | 2008/10/09 | 下载 | | 018705 | 016 | AP | Letter | 2006/10/02 | 下载 | | 018705 | 015 | AP | Letter | 2006/02/22 | 下载 | | 018705 | 013 | AP | Letter | 2004/09/03 | 下载 | | 018705 | 012 | AP | Letter | 2002/11/05 | 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 | | 018705 | 020 | AP | 2016/04/21 | Manufacturing Change or Addition | | 018705 | 019 | AP | 2015/01/23 | Labeling Revision | | 018705 | 017 | AP | 2008/10/01 | Package Change | | 018705 | 016 | AP | 2006/09/28 | Labeling Revision | | 018705 | 015 | AP | 2006/02/13 | Labeling Revision | | 018705 | 013 | AP | 2004/09/02 | Labeling Revision | | 018705 | 012 | AP | 2002/11/05 | Package Change | | 018705 | 010 | AP | 1999/11/04 | Manufacturing Change or Addition | | 018705 | 009 | AP | 1999/11/04 | Manufacturing Change or Addition | | 018705 | 008 | AP | 1999/01/13 | Labeling Revision | | 018705 | 007 | AP | 1998/04/24 | Labeling Revision | | 018705 | 006 | AP | 1997/01/10 | Comparative Efficacy Claim | | 018705 | 005 | AP | 1995/01/11 | Labeling Revision | | 018705 | 004 | AP | 1990/03/02 | Control Supplement | | 018705 | 003 | AP | 1989/11/13 | Formulation Revision | | 018705 | 002 | AP | 1988/12/02 | Labeling Revision | | 018705 | 001 | AP | 1986/04/23 | Labeling Revision | | 018705 | 000 | AP | 1985/10/31 | Approval |
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