药品名称 | CHRONULAC | 申请号 | 017884 | 产品号 | 001 | 活性成分 | LACTULOSE | 市场状态 | 停止上市 | 剂型或给药途径 | SOLUTION;ORAL | 规格 | 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | SANOFI AVENTIS US LLC
| 化学类型 | New formulation or new manufacturer | 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 | 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 | 017884 | 022 | AP | 1993/02/02 | Control Supplement | 017884 | 021 | AP | 1992/04/13 | Manufacturing Change or Addition | 017884 | 019 | AP | 1990/02/22 | Manufacturing Change or Addition | 017884 | 018 | AP | 1988/12/09 | Package Change | 017884 | 017 | AP | 1989/05/16 | Manufacturing Change or Addition | 017884 | 016 | AP | 1988/05/27 | Control Supplement | 017884 | 015 | AP | 1988/12/07 | Package Change | 017884 | 014 | AP | 1987/03/09 | Manufacturing Change or Addition | 017884 | 013 | AP | 1984/02/28 | Control Supplement | 017884 | 011 | AP | 1983/01/21 | Control Supplement | 017884 | 010 | AP | 1981/10/22 | Labeling Revision | 017884 | 009 | AP | 1981/10/22 | Expiration Date Change | 017884 | 008 | AP | 1980/10/03 | Labeling Revision | 017884 | 007 | AP | 1980/07/07 | Package Change | 017884 | 006 | AP | 1979/12/28 | Labeling Revision | 017884 | 005 | AP | 1980/03/04 | Control Supplement | 017884 | 004 | AP | 1979/12/28 | Package Change | 017884 | 003 | AP | 1980/07/29 | Control Supplement | 017884 | 002 | AP | 1979/12/28 | Control Supplement | 017884 | 001 | AP | 1979/12/28 | Package Change | 017884 | 000 | AP | 1979/06/20 | Approval |
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