药品名称 | HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 申请号 | 018609 | 产品号 | 003 | 活性成分 | HEPARIN SODIUM | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 500 UNITS/100ML | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1982/04/28 | 申请机构 | BAXTER HEALTHCARE CORP
| 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 | 018609 | 044 | AP | Letter | 2010/08/20 | 下载 | 018609 | 044 | AP | Label | 2010/08/28 | 下载 | 018609 | 042 | AP | Letter | 2012/02/29 | 下载 | 018609 | 035 | AP | Label | 2003/04/14 | 下载 | 018609 | 035 | AP | Review | 2008/04/02 | 下载 | 018609 | 033 | AP | Label | 2003/04/14 | 下载 | 018609 | 033 | AP | Review | 2008/04/02 | 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 | 018609 | 050 | AP | 2016/07/25 | Manufacturing Change or Addition | 018609 | 049 | AP | 2015/08/18 | Manufacturing Change or Addition | 018609 | 044 | AP | 2010/08/13 | Labeling Revision | 018609 | 042 | AP | 2012/02/27 | Labeling Revision | 018609 | 037 | AP | 2001/08/14 | Control Supplement | 018609 | 036 | AP | 1999/11/23 | Package Change | 018609 | 035 | AP | 2001/08/21 | Labeling Revision | 018609 | 034 | AP | 1999/06/01 | Manufacturing Change or Addition | 018609 | 033 | AP | 2001/08/21 | Labeling Revision | 018609 | 032 | AP | 1997/05/20 | Package Change | 018609 | 031 | AP | 1996/09/17 | Labeling Revision | 018609 | 030 | AP | 1994/03/10 | Control Supplement | 018609 | 029 | AP | 1994/09/14 | Manufacturing Change or Addition | 018609 | 027 | AP | 1993/04/15 | Manufacturing Change or Addition | 018609 | 025 | AP | 1991/03/04 | Control Supplement | 018609 | 024 | AP | 1990/07/26 | Control Supplement | 018609 | 023 | AP | 1991/02/01 | Package Change | 018609 | 022 | AP | 1989/08/24 | Control Supplement | 018609 | 021 | AP | 1989/11/08 | Labeling Revision | 018609 | 020 | AP | 1987/04/29 | Package Change | 018609 | 019 | AP | 1986/12/01 | Control Supplement | 018609 | 018 | AP | 1986/12/01 | Control Supplement | 018609 | 017 | AP | 1985/09/20 | Control Supplement | 018609 | 016 | AP | 1985/09/20 | Package Change | 018609 | 015 | AP | 1989/11/08 | Labeling Revision | 018609 | 014 | AP | 1984/10/16 | Control Supplement | 018609 | 013 | AP | 1984/08/03 | Manufacturing Change or Addition | 018609 | 012 | AP | 1984/02/28 | Control Supplement | 018609 | 011 | AP | 1984/03/06 | Labeling Revision | 018609 | 010 | AP | 1989/11/08 | Practioner Draft Labeling | 018609 | 009 | AP | 1984/03/06 | Control Supplement | 018609 | 008 | AP | 1984/03/06 | Package Change | 018609 | 004 | AP | 1984/03/06 | Package Change | 018609 | 003 | AP | 1982/08/09 | Package Change | 018609 | 002 | AP | 1982/08/09 | Control Supplement | 018609 | 001 | AP | 1982/06/29 | Expiration Date Change | 018609 | 000 | AP | 1982/04/28 | Approval |
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