药品名称 | CYTOTEC | 申请号 | 019268 | 产品号 | 003 | 活性成分 | MISOPROSTOL | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.1MG | 治疗等效代码 | AB | 参比药物 | 否 | 批准日期 | 1990/09/21 | 申请机构 | GD SEARLE LLC
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | 019268 | 047 | AP | Letter | 2012/11/21 | 下载 | 019268 | 047 | AP | Label | 2012/11/26 | 下载 | 019268 | 041 | AP | Label | 2009/10/06 | 下载 | 019268 | 041 | AP | Letter | 2009/11/12 | 下载 | 019268 | 040 | AP | Letter | 2003/08/14 | 下载 | 019268 | 039 | AP | Letter | 2003/08/14 | 下载 | 019268 | 037 | AP | Letter | 2002/04/17 | 下载 | 019268 | 037 | AP | Label | 2002/04/17 | 下载 | 019268 | 000 | AP | Other Important Information from FDA | 2005/07/29 | 下载 | 019268 | 000 | AP | Review | 2011/12/16 | 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 | 019268 | 048 | AP | 2013/02/08 | Manufacturing Change or Addition | 019268 | 047 | AP | 2012/11/19 | Labeling Revision | 019268 | 041 | AP | 2009/09/11 | Labeling Revision | 019268 | 040 | AP | 2003/08/13 | Labeling Revision | 019268 | 039 | AP | 2003/08/13 | Labeling Revision | 019268 | 038 | AP | 2002/07/01 | Control Supplement | 019268 | 037 | AP | 2002/04/17 | Labeling Revision | 019268 | 036 | AP | 2000/10/19 | Control Supplement | 019268 | 035 | AP | 2000/10/19 | Manufacturing Change or Addition | 019268 | 033 | AP | 2000/01/07 | Control Supplement | 019268 | 032 | AP | 1999/08/11 | Package Change | 019268 | 031 | AP | 2000/06/22 | Labeling Revision | 019268 | 030 | AP | 1998/12/03 | Expiration Date Change | 019268 | 029 | AP | 1998/10/15 | Control Supplement | 019268 | 028 | AP | 1998/10/15 | Control Supplement | 019268 | 027 | AP | 1998/07/14 | Control Supplement | 019268 | 026 | AP | 1997/07/30 | Package Change | 019268 | 025 | AP | 1997/04/10 | Control Supplement | 019268 | 024 | AP | 1996/06/10 | Manufacturing Change or Addition | 019268 | 023 | AP | 1997/08/13 | Labeling Revision | 019268 | 022 | AP | 1996/06/11 | Control Supplement | 019268 | 018 | AP | 1994/05/31 | Package Change | 019268 | 017 | AP | 1993/05/10 | Manufacturing Change or Addition | 019268 | 016 | AP | 1992/10/28 | Package Change | 019268 | 015 | AP | 1991/07/29 | Labeling Revision | 019268 | 014 | AP | 1991/04/23 | Labeling Revision | 019268 | 013 | AP | 1990/09/06 | Labeling Revision | 019268 | 012 | AP | 1990/09/21 | Formulation Revision | 019268 | 010 | AP | 1990/04/05 | Labeling Revision | 019268 | 009 | AP | 1991/06/21 | Manufacturing Change or Addition | 019268 | 008 | AP | 1990/04/05 | Labeling Revision | 019268 | 007 | AP | 1990/05/09 | Control Supplement | 019268 | 006 | AP | 1990/07/16 | Package Change | 019268 | 004 | AP | 1989/06/27 | Package Change | 019268 | 002 | AP | 1989/04/18 | Manufacturing Change or Addition | 019268 | 001 | AP | 1989/02/08 | Manufacturing Change or Addition | 019268 | 000 | AP | 1988/12/27 | Approval |
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