药品名称 | ALDOMET | 申请号 | 013400 | 产品号 | 003 | 活性成分 | METHYLDOPA | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 125MG | 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 | MERCK RESEARCH LABORATORIES DIV MERCK CO 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 | 013400 | 086 | AP | Label | 2004/09/21 | 下载 | 013400 | 086 | AP | Letter | 2004/09/21 | 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 | 013400 | 086 | AP | 2004/09/17 | Labeling Revision | 013400 | 085 | AP | 1998/11/10 | Labeling Revision | 013400 | 084 | AP | 1997/08/05 | Labeling Revision | 013400 | 083 | AP | 1997/07/07 | Control Supplement | 013400 | 082 | AP | 1997/07/07 | Control Supplement | 013400 | 081 | AP | 1997/08/05 | Labeling Revision | 013400 | 080 | AP | 1995/11/30 | Manufacturing Change or Addition | 013400 | 079 | AP | 1994/09/26 | Manufacturing Change or Addition | 013400 | 078 | AP | 1994/12/16 | Labeling Revision | 013400 | 077 | AP | 1992/09/03 | Labeling Revision | 013400 | 076 | AP | 1990/09/13 | Labeling Revision | 013400 | 075 | AP | 1988/11/22 | Labeling Revision | 013400 | 074 | AP | 1988/04/26 | Manufacturing Change or Addition | 013400 | 073 | AP | 1987/05/11 | Labeling Revision | 013400 | 072 | AP | 1985/10/22 | Labeling Revision | 013400 | 071 | AP | 1985/02/22 | Labeling Revision | 013400 | 070 | AP | 1985/01/17 | Control Supplement | 013400 | 069 | AP | 1984/07/13 | Labeling Revision | 013400 | 068 | AP | 1984/04/10 | Package Change | 013400 | 067 | AP | 1984/03/01 | Labeling Revision | 013400 | 066 | AP | 1983/12/23 | Formulation Revision | 013400 | 065 | AP | 1983/03/01 | Package Change | 013400 | 064 | AP | 1982/04/19 | Manufacturing Change or Addition | 013400 | 063 | AP | 1982/09/08 | Labeling Revision | 013400 | 062 | AP | 1982/04/07 | Formulation Revision | 013400 | 061 | AP | 1987/05/11 | Practioner Draft Labeling | 013400 | 060 | AP | 1981/10/14 | Labeling Revision | 013400 | 058 | AP | 1981/08/28 | Formulation Revision | 013400 | 057 | AP | 1981/06/17 | Package Change | 013400 | 056 | AP | 1981/11/17 | Labeling Revision | 013400 | 055 | AP | 1981/08/28 | Control Supplement | 013400 | 054 | AP | 1981/04/09 | Control Supplement | 013400 | 053 | AP | 1981/01/23 | Control Supplement | 013400 | 052 | AP | 1980/11/14 | Package Change | 013400 | 051 | AP | 1982/04/07 | Formulation Revision | 013400 | 050 | AP | 1979/10/10 | Control Supplement | 013400 | 048 | AP | 1979/07/25 | Labeling Revision | 013400 | 047 | AP | 1979/03/09 | Control Supplement | 013400 | 046 | AP | 1978/11/07 | Control Supplement | 013400 | 045 | AP | 1978/10/30 | Control Supplement | 013400 | 044 | AP | 1978/08/29 | Control Supplement | 013400 | 043 | AP | 1977/10/21 | Manufacturing Change or Addition | 013400 | 042 | AP | 1979/07/25 | Labeling Revision | 013400 | 041 | AP | 1978/06/08 | Labeling Revision | 013400 | 040 | AP | 1978/08/24 | Control Supplement | 013400 | 039 | AP | 1977/05/06 | Package Change | 013400 | 038 | AP | 1977/05/06 | Labeling Revision | 013400 | 037 | AP | 1978/02/15 | Package Change | 013400 | 036 | AP | 1977/05/02 | Package Change | 013400 | 035 | AP | 1977/02/07 | Labeling Revision | 013400 | 034 | AP | 1976/11/09 | Control Supplement | 013400 | 033 | AP | 1976/08/31 | Labeling Revision | 013400 | 032 | AP | 1976/11/09 | Control Supplement | 013400 | 031 | AP | 1976/07/22 | Labeling Revision | 013400 | 030 | AP | 1975/12/12 | Control Supplement | 013400 | 029 | AP | 1976/01/06 | Labeling Revision | 013400 | 028 | AP | 1975/06/06 | Control Supplement | 013400 | 000 | AP | 1962/12/20 | Approval |
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