药品名称 | ALDORIL 25 | 申请号 | 013402 | 产品号 | 002 | 活性成分 | HYDROCHLOROTHIAZIDE; METHYLDOPA | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 25MG;250MG | 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 AND CO INC
| 化学类型 | New combination | 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 | 013402 | 085 | AP | Letter | 2004/12/30 | 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 | 013402 | 085 | AP | 2004/12/14 | Labeling Revision | 013402 | 084 | AP | 2002/04/05 | Manufacturing Change or Addition | 013402 | 082 | AP | 1998/07/02 | Control Supplement | 013402 | 081 | AP | 1999/07/23 | Labeling Revision | 013402 | 080 | AP | 1997/08/05 | Labeling Revision | 013402 | 079 | AP | 1995/11/29 | Manufacturing Change or Addition | 013402 | 078 | AP | 1994/09/26 | Manufacturing Change or Addition | 013402 | 077 | AP | 1994/12/16 | Labeling Revision | 013402 | 076 | AP | 1994/03/07 | Labeling Revision | 013402 | 075 | AP | 1993/03/24 | Labeling Revision | 013402 | 074 | AP | 1992/09/17 | Labeling Revision | 013402 | 073 | AP | 1990/09/13 | Labeling Revision | 013402 | 072 | AP | 1992/12/18 | Labeling Revision | 013402 | 071 | AP | 1988/04/21 | Labeling Revision | 013402 | 070 | AP | 1988/04/26 | Manufacturing Change or Addition | 013402 | 069 | AP | 1987/08/26 | Labeling Revision | 013402 | 068 | AP | 1986/06/02 | Labeling Revision | 013402 | 067 | AP | 1985/10/24 | Labeling Revision | 013402 | 066 | AP | 1985/01/17 | Control Supplement | 013402 | 065 | AP | 1984/11/15 | Labeling Revision | 013402 | 064 | AP | 1984/08/13 | Labeling Revision | 013402 | 063 | AP | 1984/04/03 | Labeling Revision | 013402 | 062 | AP | 1984/04/10 | Package Change | 013402 | 061 | AP | 1984/01/23 | Manufacturing Change or Addition | 013402 | 060 | AP | 1983/12/23 | Formulation Revision | 013402 | 059 | AP | 1983/03/01 | Package Change | 013402 | 058 | AP | 1982/04/19 | Manufacturing Change or Addition | 013402 | 057 | AP | 1982/09/08 | Labeling Revision | 013402 | 056 | AP | 1987/05/08 | Practioner Draft Labeling | 013402 | 055 | AP | 1981/10/14 | Labeling Revision | 013402 | 053 | AP | 1981/06/17 | Package Change | 013402 | 052 | AP | 1981/05/11 | Labeling Revision | 013402 | 051 | AP | 1981/04/09 | Control Supplement | 013402 | 050 | AP | 1981/03/04 | Control Supplement | 013402 | 049 | AP | 1981/01/23 | Control Supplement | 013402 | 048 | AP | 1980/11/14 | Package Change | 013402 | 047 | AP | 1980/01/11 | Labeling Revision | 013402 | 046 | AP | 1980/01/03 | Package Change | 013402 | 045 | AP | 1979/10/31 | Labeling Revision | 013402 | 044 | AP | 1979/10/31 | Labeling Revision | 013402 | 043 | AP | 1979/03/09 | Control Supplement | 013402 | 042 | AP | 1981/08/28 | Control Supplement | 013402 | 041 | AP | 1978/11/07 | Control Supplement | 013402 | 040 | AP | 1978/08/29 | Control Supplement | 013402 | 039 | AP | 1978/06/26 | Package Change | 013402 | 038 | AP | 1977/10/25 | Control Supplement | 013402 | 037 | AP | 1978/06/26 | Labeling Revision | 013402 | 036 | AP | 1977/09/13 | Formulation Revision | 013402 | 035 | AP | 1977/09/13 | Formulation Revision | 013402 | 034 | AP | 1977/09/13 | Labeling Revision | 013402 | 033 | AP | 1978/02/15 | Package Change | 013402 | 032 | AP | 1979/10/31 | Labeling Revision | 013402 | 031 | AP | 1976/11/09 | Control Supplement | 013402 | 030 | AP | 1976/08/31 | Labeling Revision | 013402 | 029 | AP | 1976/03/19 | Formulation Revision | 013402 | 028 | AP | 1975/06/12 | Control Supplement | 013402 | 000 | AP | 1962/12/20 | Approval |
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