| 药品名称 | MOBAN | | 申请号 | 017111 | 产品号 | 004 | | 活性成分 | MOLINDONE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ENDO PHARMACEUTICALS INC
| | 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 | | 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 | | 017111 | 067 | AP | Label | 2010/12/04 | 下载 | | 017111 | 067 | AP | Letter | 2010/12/06 | 下载 | | 017111 | 066 | AP | Label | 2009/07/23 | 下载 | | 017111 | 066 | AP | Letter | 2009/07/23 | 下载 | | 017111 | 063 | AP | Letter | 2008/08/19 | 下载 | | 017111 | 063 | AP | Label | 2008/08/29 | 下载 | | 017111 | 062 | AP | Letter | 2008/03/17 | 下载 | | 017111 | 062 | AP | Label | 2008/03/17 | 下载 | | 017111 | 055 | AP | Letter | 2003/04/09 | 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 | | 017111 | 067 | AP | 2010/12/01 | Labeling Revision | | 017111 | 066 | AP | 2009/07/19 | Labeling Revision | | 017111 | 063 | AP | 2008/08/14 | Labeling Revision | | 017111 | 062 | AP | 2008/03/12 | Labeling Revision | | 017111 | 055 | AP | 2001/05/22 | Labeling Revision | | 017111 | 054 | AP | 1998/08/21 | Control Supplement | | 017111 | 053 | AP | 1998/08/21 | Manufacturing Change or Addition | | 017111 | 051 | AP | 1996/04/25 | Control Supplement | | 017111 | 050 | AP | 1995/08/28 | Control Supplement | | 017111 | 049 | AP | 1995/08/28 | Control Supplement | | 017111 | 048 | AP | 1995/08/28 | Control Supplement | | 017111 | 047 | AP | 1994/08/12 | Manufacturing Change or Addition | | 017111 | 046 | AP | 1988/08/08 | Manufacturing Change or Addition | | 017111 | 045 | AP | 1988/06/28 | Labeling Revision | | 017111 | 044 | AP | 1988/06/28 | Package Change | | 017111 | 043 | AP | 1987/09/23 | Manufacturing Change or Addition | | 017111 | 039 | AP | 1986/06/11 | Package Change | | 017111 | 036 | AP | 1985/06/26 | Package Change | | 017111 | 033 | AP | 1982/11/19 | Labeling Revision | | 017111 | 030 | AP | 1981/03/24 | Labeling Revision | | 017111 | 029 | AP | 1981/01/06 | Formulation Revision | | 017111 | 028 | AP | 1979/08/16 | Labeling Revision | | 017111 | 027 | AP | 1979/09/27 | Package Change | | 017111 | 026 | AP | 1979/05/10 | Labeling Revision | | 017111 | 023 | AP | 1979/12/20 | Expiration Date Change | | 017111 | 021 | AP | 1981/01/05 | Formulation Revision | | 017111 | 017 | AP | 1977/06/07 | Control Supplement | | 017111 | 014 | AP | 1977/02/07 | Formulation Revision | | 017111 | 012 | AP | 1977/02/07 | Formulation Revision | | 017111 | 011 | AP | 1977/05/27 | Package Change | | 017111 | 010 | AP | 1977/03/14 | Control Supplement | | 017111 | 008 | AP | 1976/08/26 | Package Change | | 017111 | 007 | AP | 1976/09/20 | Labeling Revision | | 017111 | 004 | AP | 1974/09/23 | Control Supplement | | 017111 | 000 | AP | 1974/01/18 | Approval |
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