药品名称 | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | 申请号 | 018461 | 产品号 | 004 | 活性成分 | LIDOCAINE HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 800MG/100ML | 治疗等效代码 | AP | 参比药物 | 否 | 批准日期 | 1982/02/22 | 申请机构 | BAXTER HEALTHCARE CORP
| 化学类型 | New dosage form | 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 | 018461 | 056 | AP | Label | 2012/03/05 | 下载![](pdf.jpg) | 018461 | 056 | AP | Letter | 2012/03/12 | 下载![](pdf.jpg) | 018461 | 055 | AP | Letter | 2012/02/29 | 下载![](pdf.jpg) | 018461 | 052 | AP | Letter | 2003/12/16 | 下载![](pdf.jpg) | 018461 | 050 | AP | Letter | 2002/01/23 | 下载![](pdf.jpg) | 018461 | 050 | AP | Label | 2002/01/23 | 下载![](pdf.jpg) | 018461 | 050 | AP | Review | 2002/09/10 | 下载![](pdf.jpg) |
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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 | 018461 | 057 | AP | 2015/04/07 | Manufacturing Change or Addition | 018461 | 056 | AP | 2012/03/05 | Labeling Revision | 018461 | 055 | AP | 2012/02/27 | Labeling Revision | 018461 | 052 | AP | 2003/12/11 | Labeling Revision | 018461 | 050 | AP | 2002/01/23 | Labeling Revision | 018461 | 048 | AP | 1999/11/23 | Package Change | 018461 | 047 | AP | 1999/06/03 | Manufacturing Change or Addition | 018461 | 046 | AP | 1998/09/18 | Labeling Revision | 018461 | 045 | AP | 1994/09/29 | Control Supplement | 018461 | 044 | AP | 1994/03/16 | Control Supplement | 018461 | 043 | AP | 1993/01/08 | Labeling Revision | 018461 | 041 | AP | 1991/04/03 | Control Supplement | 018461 | 040 | AP | 1991/04/29 | Control Supplement | 018461 | 039 | AP | 1990/05/24 | Control Supplement | 018461 | 038 | AP | 1991/03/26 | Control Supplement | 018461 | 037 | AP | 1991/02/15 | Control Supplement | 018461 | 036 | AP | 1989/07/26 | Control Supplement | 018461 | 035 | AP | 1989/01/12 | Control Supplement | 018461 | 033 | AP | 1987/07/25 | Package Change | 018461 | 032 | AP | 1987/05/28 | Control Supplement | 018461 | 028 | AP | 1986/02/27 | Package Change | 018461 | 027 | AP | 1985/04/15 | Control Supplement | 018461 | 026 | AP | 1985/09/13 | Labeling Revision | 018461 | 025 | AP | 1985/06/13 | Control Supplement | 018461 | 024 | AP | 1984/10/23 | Control Supplement | 018461 | 023 | AP | 1986/09/04 | Practioner Draft Labeling | 018461 | 022 | AP | 1984/02/28 | Control Supplement | 018461 | 021 | AP | 1984/04/30 | Labeling Revision | 018461 | 020 | AP | 1985/06/11 | Control Supplement | 018461 | 018 | AP | 1983/03/14 | Control Supplement | 018461 | 017 | AP | 1985/01/24 | Control Supplement | 018461 | 014 | AP | 1984/03/16 | Control Supplement | 018461 | 012 | AP | 1982/05/25 | Labeling Revision | 018461 | 011 | AP | 1981/11/20 | Control Supplement | 018461 | 009 | AP | 1982/02/22 | Labeling Revision | 018461 | 008 | AP | 1982/02/22 | Control Supplement | 018461 | 007 | AP | 1982/06/03 | Control Supplement | 018461 | 006 | AP | 1981/10/01 | Labeling Revision | 018461 | 005 | AP | 1981/10/01 | Control Supplement | 018461 | 004 | AP | 1982/04/16 | Control Supplement | 018461 | 003 | AP | 1981/12/21 | Control Supplement | 018461 | 002 | AP | 1981/07/27 | Labeling Revision | 018461 | 001 | AP | 1981/07/22 | Control Supplement | 018461 | 000 | AP | 1981/04/22 | Approval |
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