药品名称 | RENAMIN W/O ELECTROLYTES | 申请号 | 017493 | 产品号 | 007 | 活性成分 | AMINO ACIDS | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 6.5% (6.5GM/100ML) | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1982/10/15 | 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 | 017493 | 067 | AP | Letter | 2003/01/17 | 下载 | 017493 | 066 | AP | Letter | 2003/05/30 | 下载 | 017493 | 065 | AP | Letter | 2003/01/03 | 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 | 017493 | 067 | AP | 2003/01/17 | Control Supplement | 017493 | 066 | AP | 2003/04/30 | Labeling Revision | 017493 | 065 | AP | 2003/01/03 | Labeling Revision | 017493 | 064 | AP | 1999/03/31 | Control Supplement | 017493 | 063 | AP | 1999/04/05 | Control Supplement | 017493 | 062 | AP | 1994/02/18 | Control Supplement | 017493 | 061 | AP | 1994/05/19 | Manufacturing Change or Addition | 017493 | 060 | AP | 1994/09/30 | Control Supplement | 017493 | 059 | AP | 1992/08/24 | Manufacturing Change or Addition | 017493 | 058 | AP | 1991/04/03 | Control Supplement | 017493 | 057 | AP | 1992/09/14 | Control Supplement | 017493 | 056 | AP | 1993/03/12 | Labeling Revision | 017493 | 055 | AP | 1991/03/26 | Control Supplement | 017493 | 054 | AP | 1990/05/04 | Control Supplement | 017493 | 053 | AP | 1993/03/12 | Labeling Revision | 017493 | 052 | AP | 1997/04/30 | Package Change | 017493 | 051 | AP | 1989/07/26 | Control Supplement | 017493 | 049 | AP | 1987/12/30 | Package Change | 017493 | 048 | AP | 1987/11/18 | Labeling Revision | 017493 | 047 | AP | 1987/07/25 | Package Change | 017493 | 046 | AP | 1985/09/20 | Labeling Revision | 017493 | 045 | AP | 1984/02/28 | Control Supplement | 017493 | 043 | AP | 1983/01/19 | Labeling Revision | 017493 | 042 | AP | 1983/01/19 | Control Supplement | 017493 | 041 | AP | 1985/01/24 | Control Supplement | 017493 | 039 | AP | 1982/07/21 | Manufacturing Change or Addition | 017493 | 038 | AP | 1982/03/08 | Control Supplement | 017493 | 037 | AP | 1982/04/06 | Labeling Revision | 017493 | 036 | AP | 1982/04/06 | Control Supplement | 017493 | 035 | AP | 1982/02/16 | Control Supplement | 017493 | 034 | AP | 1981/12/16 | Control Supplement | 017493 | 033 | AP | 1982/10/15 | Labeling Revision | 017493 | 032 | AP | 1982/10/15 | Control Supplement | 017493 | 030 | AP | 1981/06/29 | Control Supplement | 017493 | 029 | AP | 1981/06/17 | Labeling Revision | 017493 | 028 | AP | 1981/06/17 | Formulation Revision | 017493 | 025 | AP | 1980/07/31 | Control Supplement | 017493 | 024 | AP | 1980/06/03 | Control Supplement | 017493 | 023 | AP | 1979/06/04 | Control Supplement | 017493 | 021 | AP | 1979/04/27 | Labeling Revision | 017493 | 020 | AP | 1979/11/28 | Labeling Revision | 017493 | 019 | AP | 1979/11/28 | Control Supplement | 017493 | 018 | AP | 1978/07/28 | Control Supplement | 017493 | 017 | AP | 1978/07/28 | Labeling Revision | 017493 | 016 | AP | 1978/08/29 | Control Supplement | 017493 | 015 | AP | 1977/12/13 | Labeling Revision | 017493 | 014 | AP | 1977/08/18 | Control Supplement | 017493 | 013 | AP | 1977/07/12 | Labeling Revision | 017493 | 012 | AP | 1977/07/12 | Control Supplement | 017493 | 011 | AP | 1977/07/22 | Manufacturing Change or Addition | 017493 | 010 | AP | 1979/05/10 | Control Supplement | 017493 | 009 | AP | 1977/02/07 | Control Supplement | 017493 | 008 | AP | 1977/04/01 | Control Supplement | 017493 | 007 | AP | 1977/04/01 | Labeling Revision | 017493 | 006 | AP | 1977/12/07 | Labeling Revision | 017493 | 005 | AP | 1976/08/24 | Control Supplement | 017493 | 004 | AP | 1976/06/28 | Control Supplement | 017493 | 003 | AP | 1976/09/08 | Labeling Revision | 017493 | 001 | AP | 1976/07/19 | Control Supplement | 017493 | 000 | AP | 1976/03/24 | Approval |
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