药品名称 | MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | 申请号 | 016964 | 产品号 | 013 | 活性成分 | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 0.25%;0.0091MG/ML | 治疗等效代码 | AP | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | HOSPIRA INC
| 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 | 016964 | 070 | AP | Label | 2012/01/30 | 下载 | 016964 | 070 | AP | Letter | 2012/02/01 | 下载 | 016964 | 069 | AP | Letter | 2010/02/25 | 下载 | 016964 | 069 | AP | Label | 2010/02/25 | 下载 | 016964 | 061 | AP | Label | 2005/11/01 | 下载 | 016964 | 061 | AP | Letter | 2005/11/01 | 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 | 016964 | 073 | AP | 2014/12/15 | Manufacturing Change or Addition | 016964 | 072 | AP | 2014/09/19 | Manufacturing Change or Addition | 016964 | 071 | AP | 2013/07/30 | Manufacturing Change or Addition | 016964 | 070 | AP | 2012/01/30 | Labeling Revision | 016964 | 069 | AP | 2010/02/19 | Labeling Revision | 016964 | 061 | AP | 2005/10/30 | Labeling Revision | 016964 | 053 | AP | 2001/01/31 | Control Supplement | 016964 | 052 | AP | 1999/03/11 | Labeling Revision | 016964 | 051 | AP | 1999/03/11 | Labeling Revision | 016964 | 050 | AP | 1997/04/09 | Manufacturing Change or Addition | 016964 | 048 | AP | 1999/03/11 | Labeling Revision | 016964 | 047 | AP | 1993/01/25 | Control Supplement | 016964 | 046 | AP | 1999/03/11 | Labeling Revision | 016964 | 045 | AP | 1991/08/08 | Labeling Revision | 016964 | 044 | AP | 1991/02/06 | Package Change | 016964 | 043 | AP | 1991/02/06 | Control Supplement | 016964 | 042 | AP | 1988/04/27 | Package Change | 016964 | 041 | AP | 1987/07/13 | Labeling Revision | 016964 | 040 | AP | 1987/09/15 | Control Supplement | 016964 | 039 | AP | 1987/01/27 | Labeling Revision | 016964 | 038 | AP | 1987/01/27 | Package Change | 016964 | 037 | AP | 1985/08/24 | Labeling Revision | 016964 | 036 | AP | 1985/08/19 | Labeling Revision | 016964 | 035 | AP | 1985/09/11 | Labeling Revision | 016964 | 034 | AP | 1983/12/01 | Labeling Revision | 016964 | 031 | AP | 1985/05/20 | Package Change | 016964 | 030 | AP | 1983/01/21 | Control Supplement | 016964 | 029 | AP | 1983/07/13 | Labeling Revision | 016964 | 028 | AP | 1983/07/13 | Control Supplement | 016964 | 025 | AP | 1984/03/02 | Expiration Date Change | 016964 | 024 | AP | 1983/11/21 | Practioner Draft Labeling | 016964 | 023 | AP | 1981/12/28 | Labeling Revision | 016964 | 022 | AP | 1981/08/21 | Labeling Revision | 016964 | 021 | AP | 1981/08/21 | Control Supplement | 016964 | 020 | AP | 1982/01/27 | Control Supplement | 016964 | 019 | AP | 1980/11/03 | Labeling Revision | 016964 | 018 | AP | 1979/12/06 | Control Supplement | 016964 | 017 | AP | 1979/06/18 | Labeling Revision | 016964 | 016 | AP | 1979/04/04 | Control Supplement | 016964 | 015 | AP | 1980/08/21 | Labeling Revision | 016964 | 014 | AP | 1980/08/21 | Control Supplement | 016964 | 013 | AP | 1979/04/04 | Control Supplement | 016964 | 012 | AP | 1978/06/15 | Control Supplement | 016964 | 011 | AP | 1978/06/15 | Control Supplement | 016964 | 008 | AP | 1976/07/07 | Manufacturing Change or Addition | 016964 | 007 | AP | 1976/11/30 | Final Printed Labeling - MarkIV | 016964 | 006 | AP | 1976/06/10 | Control Supplement | 016964 | 005 | AP | 1976/06/07 | Control Supplement | 016964 | 004 | AP | 1976/06/10 | Labeling Revision | 016964 | 003 | AP | 1976/01/13 | Labeling Revision | 016964 | 000 | AP | 1972/10/03 | Approval |
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