药品名称 | ETHRANE | 申请号 | 017087 | 产品号 | 001 | 活性成分 | ENFLURANE | 市场状态 | 停止上市 | 剂型或给药途径 | LIQUID;INHALATION | 规格 | 99.9% | 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 | BAXTER HEALTHCARE CORP
| 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 | 017087 | 048 | AP | Label | 2010/01/24 | 下载 | 017087 | 048 | AP | Letter | 2010/01/28 | 下载 | 017087 | 047 | AP | Label | 2006/09/21 | 下载 | 017087 | 047 | AP | Letter | 2006/09/25 | 下载 | 017087 | 045 | AP | Letter | 2002/10/08 | 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 | 017087 | 048 | AP | 2010/01/21 | Labeling Revision | 017087 | 047 | AP | 2006/09/20 | Labeling Revision | 017087 | 045 | AP | 2002/10/08 | Labeling Revision | 017087 | 044 | AP | 2000/09/22 | Manufacturing Change or Addition | 017087 | 043 | AP | 1998/12/09 | Control Supplement | 017087 | 042 | AP | 1996/07/01 | Control Supplement | 017087 | 041 | AP | 1995/07/05 | Labeling Revision | 017087 | 040 | AP | 1990/03/21 | Manufacturing Change or Addition | 017087 | 039 | AP | 1987/02/25 | Package Change | 017087 | 038 | AP | 1986/04/16 | Package Change | 017087 | 037 | AP | 1986/04/16 | Labeling Revision | 017087 | 036 | AP | 1986/04/16 | Labeling Revision | 017087 | 035 | AP | 1985/03/24 | Labeling Revision | 017087 | 034 | AP | 1984/05/16 | Control Supplement | 017087 | 033 | AP | 1985/04/17 | Practioner Draft Labeling | 017087 | 032 | AP | 1984/06/06 | Labeling Revision | 017087 | 031 | AP | 1985/04/17 | Labeling Revision | 017087 | 030 | AP | 1981/09/24 | Control Supplement | 017087 | 029 | AP | 1981/10/28 | Control Supplement | 017087 | 028 | AP | 1982/02/22 | Labeling Revision | 017087 | 027 | AP | 1980/07/24 | Control Supplement | 017087 | 026 | AP | 1979/12/04 | Control Supplement | 017087 | 025 | AP | 1980/07/10 | Labeling Revision | 017087 | 024 | AP | 1979/12/04 | Control Supplement | 017087 | 023 | AP | 1979/09/06 | Control Supplement | 017087 | 022 | AP | 1979/04/16 | Control Supplement | 017087 | 020 | AP | 1977/09/10 | Control Supplement | 017087 | 019 | AP | 1977/10/06 | Labeling Revision | 017087 | 018 | AP | 1978/05/30 | Package Change | 017087 | 017 | AP | 1977/05/03 | Labeling Revision | 017087 | 016 | AP | 1976/11/04 | Control Supplement | 017087 | 015 | AP | 1976/11/04 | Control Supplement | 017087 | 014 | AP | 1976/09/03 | Manufacturing Change or Addition | 017087 | 013 | AP | 1975/10/07 | Control Supplement | 017087 | 012 | AP | 1975/08/04 | Control Supplement | 017087 | 011 | AP | 1976/03/26 | Labeling Revision | 017087 | 010 | AP | 1975/06/18 | Control Supplement | 017087 | 009 | AP | 1975/07/16 | Control Supplement | 017087 | 008 | AP | 1974/11/11 | Control Supplement | 017087 | 004 | AP | 1974/07/17 | Supplement | 017087 | 000 | AP | 1972/08/28 | Approval |
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