药品名称 | STERILE WATER FOR INJECTION IN PLASTIC CONTAINER | 申请号 | 018233 | 产品号 | 001 | 活性成分 | STERILE WATER FOR INJECTION | 市场状态 | 处方药 | 剂型或给药途径 | LIQUID;N/A | 规格 | 100% | 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 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 | 018233 | 068 | AP | Letter | 2007/11/08 | 下载 | 018233 | 063 | AP | Letter | 2005/01/26 | 下载 | 018233 | 062 | AP | Letter | 2003/01/24 | 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 | 018233 | 080 | AP | 2013/09/05 | Manufacturing Change or Addition | 018233 | 068 | AP | 2007/11/02 | Package Change | 018233 | 063 | AP | 2005/01/19 | Labeling Revision | 018233 | 062 | AP | 2003/01/24 | Control Supplement | 018233 | 061 | AP | 2002/10/15 | Expiration Date Change | 018233 | 060 | AP | 1999/06/04 | Control Supplement | 018233 | 059 | AP | 1998/10/29 | Control Supplement | 018233 | 058 | AP | 1997/06/11 | Manufacturing Change or Addition | 018233 | 057 | AP | 2000/06/14 | Labeling Revision | 018233 | 056 | AP | 1996/08/06 | Control Supplement | 018233 | 055 | AP | 1996/03/04 | Control Supplement | 018233 | 054 | AP | 1996/08/29 | Control Supplement | 018233 | 053 | AP | 1996/08/27 | Control Supplement | 018233 | 052 | AP | 1995/08/14 | Control Supplement | 018233 | 049 | AP | 1991/08/30 | Package Change | 018233 | 048 | AP | 1992/01/28 | Package Change | 018233 | 047 | AP | 1991/09/10 | Control Supplement | 018233 | 045 | AP | 1990/01/11 | Manufacturing Change or Addition | 018233 | 044 | AP | 1990/02/22 | Manufacturing Change or Addition | 018233 | 041 | AP | 1987/07/30 | Control Supplement | 018233 | 040 | AP | 1986/11/26 | Control Supplement | 018233 | 039 | AP | 1986/08/08 | Control Supplement | 018233 | 038 | AP | 1985/06/10 | Control Supplement | 018233 | 036 | AP | 1986/01/31 | Control Supplement | 018233 | 034 | AP | 1985/10/26 | Labeling Revision | 018233 | 033 | AP | 1985/05/03 | Control Supplement | 018233 | 032 | AP | 1985/10/26 | Control Supplement | 018233 | 029 | AP | 1984/10/22 | Control Supplement | 018233 | 028 | AP | 1985/09/26 | Package Change | 018233 | 026 | AP | 1985/11/29 | Labeling Revision | 018233 | 025 | AP | 1985/11/29 | Control Supplement | 018233 | 024 | AP | 1985/10/29 | Package Change | 018233 | 023 | AP | 1984/04/09 | Control Supplement | 018233 | 022 | AP | 1983/11/07 | Expiration Date Change | 018233 | 021 | AP | 1984/10/17 | Control Supplement | 018233 | 020 | AP | 1984/03/21 | Control Supplement | 018233 | 019 | AP | 1983/12/08 | Control Supplement | 018233 | 018 | AP | 1984/10/10 | Labeling Revision | 018233 | 017 | AP | 1984/10/10 | Package Change | 018233 | 016 | AP | 1982/07/26 | Control Supplement | 018233 | 015 | AP | 1984/03/01 | Control Supplement | 018233 | 014 | AP | 1983/02/15 | Manufacturing Change or Addition | 018233 | 013 | AP | 1982/07/08 | Control Supplement | 018233 | 012 | AP | 1982/01/08 | Control Supplement | 018233 | 011 | AP | 1982/06/09 | Control Supplement | 018233 | 010 | AP | 1981/10/07 | Control Supplement | 018233 | 009 | AP | 1981/03/02 | Labeling Revision | 018233 | 008 | AP | 1982/03/12 | Practioner Draft Labeling | 018233 | 007 | AP | 1981/03/02 | Labeling Revision | 018233 | 006 | AP | 1981/03/02 | Control Supplement | 018233 | 005 | AP | 1981/01/07 | Control Supplement | 018233 | 004 | AP | 1980/09/15 | Control Supplement | 018233 | 003 | AP | 1980/05/28 | Control Supplement | 018233 | 002 | AP | 1980/05/23 | Control Supplement | 018233 | 001 | AP | 1980/05/14 | Control Supplement | 018233 | 000 | AP | 1980/02/18 | Approval |
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