药品名称 | TRANSDERM SCOP | 申请号 | 017874 | 产品号 | 001 | 活性成分 | SCOPOLAMINE | 市场状态 | 处方药 | 剂型或给药途径 | FILM, EXTENDED RELEASE;TRANSDERMAL | 规格 | 1MG/72HR | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | GLAXOSMITHKLINE CONSUMER HEALTH
| 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 | 017874 | 038 | AP | Letter | 2013/05/02 | 下载 | 017874 | 038 | AP | Label | 2013/05/30 | 下载 | 017874 | 035 | AP | Letter | 2007/01/16 | 下载 | 017874 | 032 | AP | Letter | 2002/03/22 | 下载 | 017874 | 027 | AP | Letter | 2001/07/26 | 下载 | 017874 | 027 | AP | Label | 2003/04/11 | 下载 | 017874 | 027 | AP | Review | 2007/07/09 | 下载 | 017874 | 018 | AP | Review | 2007/07/09 | 下载 | 017874 | 018 | AP | Label | 2003/04/10 | 下载 | 017874 | 018 | AP | Letter | 2001/07/26 | 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 | 017874 | 040 | AP | 2013/05/15 | Manufacturing Change or Addition | 017874 | 038 | AP | 2013/04/30 | Labeling Revision | 017874 | 035 | AP | 2007/01/10 | Labeling Revision | 017874 | 032 | AP | 2002/03/22 | Labeling Revision | 017874 | 030 | AP | 2000/05/30 | Manufacturing Change or Addition | 017874 | 029 | AP | 1998/06/19 | Manufacturing Change or Addition | 017874 | 028 | AP | 1996/10/07 | Control Supplement | 017874 | 027 | AP | 2001/07/26 | Labeling Revision | 017874 | 026 | AP | 1994/05/31 | Control Supplement | 017874 | 025 | AP | 1993/02/10 | Manufacturing Change or Addition | 017874 | 024 | AP | 1993/06/28 | Manufacturing Change or Addition | 017874 | 023 | AP | 1992/03/05 | Manufacturing Change or Addition | 017874 | 022 | AP | 1990/07/10 | Package Change | 017874 | 018 | AP | 2001/07/26 | Labeling Revision | 017874 | 017 | AP | 1988/10/03 | Manufacturing Change or Addition | 017874 | 016 | AP | 1988/03/17 | Control Supplement | 017874 | 014 | AP | 1984/07/25 | Manufacturing Change or Addition | 017874 | 013 | AP | 1982/06/02 | Control Supplement | 017874 | 011 | AP | 1981/11/02 | Control Supplement | 017874 | 009 | AP | 1981/10/27 | Labeling Revision | 017874 | 006 | AP | 1981/02/09 | Expiration Date Change | 017874 | 005 | AP | 1981/04/10 | Manufacturing Change or Addition | 017874 | 001 | AP | 1980/01/28 | Expiration Date Change | 017874 | 000 | AP | 1979/12/31 | Approval |
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