药品名称 | URECHOLINE | 申请号 | 006536 | 产品号 | 001 | 活性成分 | BETHANECHOL CHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ODYSSEY PHARMACEUTICALS INC
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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 | 无 |
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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 | 006536 | 043 | AP | 1998/01/20 | Control Supplement | 006536 | 042 | AP | 1998/03/31 | Control Supplement | 006536 | 041 | AP | 1997/08/14 | Control Supplement | 006536 | 040 | AP | 1996/09/03 | Manufacturing Change or Addition | 006536 | 039 | AP | 1996/03/11 | Control Supplement | 006536 | 038 | AP | 1998/04/02 | Labeling Revision | 006536 | 037 | AP | 1995/09/11 | Manufacturing Change or Addition | 006536 | 036 | AP | 1993/08/09 | Labeling Revision | 006536 | 035 | AP | 1992/08/28 | Control Supplement | 006536 | 034 | AP | 1987/03/09 | Labeling Revision | 006536 | 033 | AP | 1985/09/12 | Control Supplement | 006536 | 032 | AP | 1985/07/03 | Package Change | 006536 | 031 | AP | 1984/10/11 | Package Change | 006536 | 030 | AP | 1984/10/24 | Control Supplement | 006536 | 029 | AP | 1983/09/16 | Formulation Revision | 006536 | 028 | AP | 1986/01/14 | Practioner Draft Labeling | 006536 | 027 | AP | 1981/07/14 | Package Change | 006536 | 026 | AP | 1981/11/03 | Manufacturing Change or Addition | 006536 | 025 | AP | 1981/06/17 | Package Change | 006536 | 024 | AP | 1980/12/22 | Formulation Revision | 006536 | 023 | AP | 1980/05/01 | Labeling Revision | 006536 | 022 | AP | 1980/05/29 | Control Supplement | 006536 | 021 | AP | 1980/06/24 | Labeling Revision | 006536 | 020 | AP | 1979/08/13 | Labeling Revision | 006536 | 018 | AP | 1980/05/01 | Labeling Revision | 006536 | 017 | AP | 1980/05/01 | Labeling Revision | 006536 | 016 | AP | 1978/10/02 | Labeling Revision | 006536 | 015 | AP | 1977/12/12 | Control Supplement | 006536 | 014 | AP | 1977/09/19 | Labeling Revision | 006536 | 013 | AP | 1976/05/17 | Labeling Revision | 006536 | 012 | AP | 1976/05/17 | Control Supplement | 006536 | 000 | AP | 1948/10/12 | Approval |
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