| 药品名称 | ROBINUL | | 申请号 | 017558 | 产品号 | 001 | | 活性成分 | GLYCOPYRROLATE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
| | 化学类型 | New dosage form | 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 | | 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 | | 017558 | 053 | AP | Letter | 2005/05/27 | 下载 | | 017558 | 053 | AP | Label | 2005/05/27 | 下载 | | 017558 | 050 | AP | Letter | 2004/11/08 | 下载 | | 017558 | 049 | AP | Letter | 2004/11/08 | 下载 | | 017558 | 048 | AP | Letter | 2003/07/06 | 下载 | | 017558 | 047 | AP | Letter | 2003/07/06 | 下载 | | 017558 | 046 | AP | Letter | 2004/11/08 | 下载 | | 017558 | 045 | AP | Letter | 2004/11/08 | 下载 | | 017558 | 000 | AP | Review | 2007/02/20 | 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 | | 017558 | 060 | AP | 2014/03/18 | Manufacturing Change or Addition | | 017558 | 053 | AP | 2005/05/26 | Labeling Revision | | 017558 | 050 | AP | 2004/11/05 | Labeling Revision | | 017558 | 049 | AP | 2004/11/05 | Labeling Revision | | 017558 | 048 | AP | 2003/06/30 | Labeling Revision | | 017558 | 047 | AP | 2003/06/30 | Labeling Revision | | 017558 | 046 | AP | 2004/11/05 | Labeling Revision | | 017558 | 045 | AP | 2004/11/05 | Labeling Revision | | 017558 | 043 | AP | 2001/04/26 | Manufacturing Change or Addition | | 017558 | 042 | AP | 1998/02/13 | Manufacturing Change or Addition | | 017558 | 041 | AP | 1988/09/06 | Formulation Revision | | 017558 | 040 | AP | 1988/06/06 | Control Supplement | | 017558 | 039 | AP | 1988/04/18 | Control Supplement | | 017558 | 038 | AP | 1987/03/16 | Control Supplement | | 017558 | 037 | AP | 1986/06/12 | Control Supplement | | 017558 | 036 | AP | 1986/06/12 | Control Supplement | | 017558 | 035 | AP | 1986/07/24 | Control Supplement | | 017558 | 030 | AP | 1983/03/02 | Control Supplement | | 017558 | 029 | AP | 1983/03/02 | Control Supplement | | 017558 | 028 | AP | 1982/03/04 | Manufacturing Change or Addition | | 017558 | 027 | AP | 1982/01/19 | Control Supplement | | 017558 | 026 | AP | 1981/11/06 | Expiration Date Change | | 017558 | 025 | AP | 1981/09/24 | Control Supplement | | 017558 | 024 | AP | 1981/10/22 | Labeling Revision | | 017558 | 023 | AP | 1981/10/22 | Labeling Revision | | 017558 | 022 | AP | 1981/10/22 | Control Supplement | | 017558 | 019 | AP | 1980/09/26 | Control Supplement | | 017558 | 018 | AP | 1980/12/04 | Labeling Revision | | 017558 | 017 | AP | 1980/04/01 | Labeling Revision | | 017558 | 016 | AP | 1980/04/01 | Control Supplement | | 017558 | 015 | AP | 1980/04/01 | Labeling Revision | | 017558 | 014 | AP | 1980/04/01 | Control Supplement | | 017558 | 011 | AP | 1978/11/30 | Control Supplement | | 017558 | 010 | AP | 1978/08/17 | Labeling Revision | | 017558 | 009 | AP | 1978/08/17 | Labeling Revision | | 017558 | 008 | AP | 1978/04/25 | Labeling Revision | | 017558 | 004 | AP | 1976/11/02 | Labeling Revision | | 017558 | 003 | AP | 1976/09/22 | Control Supplement | | 017558 | 001 | AP | 1975/11/05 | Labeling Revision | | 017558 | 000 | AP | 1975/02/06 | Approval |
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