药品名称 | LIORESAL | 申请号 | 017851 | 产品号 | 003 | 活性成分 | BACLOFEN | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 20MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1982/01/20 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 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 | 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 | 017851 | 041 | AP | 2000/04/11 | Manufacturing Change or Addition | 017851 | 040 | AP | 1999/04/21 | Package Change | 017851 | 039 | AP | 1995/08/18 | Package Change | 017851 | 038 | AP | 1995/08/18 | Control Supplement | 017851 | 036 | AP | 1990/04/05 | Package Change | 017851 | 034 | AP | 1989/11/17 | Labeling Revision | 017851 | 031 | AP | 1989/04/07 | Package Change | 017851 | 029 | AP | 1985/05/14 | Manufacturing Change or Addition | 017851 | 028 | AP | 1984/11/16 | Control Supplement | 017851 | 027 | AP | 1984/02/28 | Manufacturing Change or Addition | 017851 | 026 | AP | 1984/02/15 | Control Supplement | 017851 | 025 | AP | 1986/02/28 | Labeling Revision | 017851 | 024 | AP | 1984/03/21 | Labeling Revision | 017851 | 023 | AP | 1983/03/07 | Control Supplement | 017851 | 022 | AP | 1982/10/18 | Package Change | 017851 | 021 | AP | 1982/03/18 | Package Change | 017851 | 019 | AP | 1983/03/02 | Labeling Revision | 017851 | 017 | AP | 1985/01/24 | Control Supplement | 017851 | 016 | AP | 1981/09/24 | Formulation Revision | 017851 | 015 | AP | 1982/01/20 | Labeling Revision | 017851 | 014 | AP | 1981/05/14 | Formulation Revision | 017851 | 013 | AP | 1981/05/14 | Expiration Date Change | 017851 | 012 | AP | 1981/04/21 | Package Change | 017851 | 011 | AP | 1980/10/06 | Package Change | 017851 | 009 | AP | 1980/05/23 | Manufacturing Change or Addition | 017851 | 008 | AP | 1980/03/19 | Labeling Revision | 017851 | 007 | AP | 1981/02/03 | Package Change | 017851 | 006 | AP | 1979/04/13 | Package Change | 017851 | 005 | AP | 1979/12/31 | Control Supplement | 017851 | 004 | AP | 1979/12/31 | Control Supplement | 017851 | 003 | AP | 1979/03/21 | Package Change | 017851 | 002 | AP | 1978/05/16 | Expiration Date Change | 017851 | 001 | AP | 1978/04/04 | Labeling Revision | 017851 | 000 | AP | 1977/11/22 | Approval |
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