药品名称 | VALIUM | 申请号 | 016087 | 产品号 | 001 | 活性成分 | DIAZEPAM | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | HOFFMANN LA ROCHE INC
| 化学类型 | New dosage form | 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 | 016087 | 081 | AP | Letter | 2002/02/07 | 下载 | 016087 | 079 | AP | Letter | 2002/02/07 | 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 | 016087 | 084 | AP | 1998/09/04 | Control Supplement | 016087 | 083 | AP | 1997/09/17 | Control Supplement | 016087 | 082 | AP | 1997/11/05 | Manufacturing Change or Addition | 016087 | 081 | AP | 2002/02/07 | Labeling Revision | 016087 | 080 | AP | 1993/05/25 | Control Supplement | 016087 | 079 | AP | 2002/02/07 | Labeling Revision | 016087 | 078 | AP | 1987/04/23 | Control Supplement | 016087 | 077 | AP | 1987/10/27 | Control Supplement | 016087 | 076 | AP | 1986/10/29 | Control Supplement | 016087 | 074 | AP | 1986/06/16 | Control Supplement | 016087 | 072 | AP | 1986/06/16 | Package Change | 016087 | 071 | AP | 1986/01/15 | Package Change | 016087 | 070 | AP | 1985/08/06 | Manufacturing Change or Addition | 016087 | 069 | AP | 1985/06/27 | Labeling Revision | 016087 | 068 | AP | 1985/05/31 | Manufacturing Change or Addition | 016087 | 067 | AP | 1985/06/26 | Control Supplement | 016087 | 066 | AP | 1985/06/26 | Control Supplement | 016087 | 063 | AP | 1983/04/18 | Package Change | 016087 | 062 | AP | 1983/03/29 | Control Supplement | 016087 | 061 | AP | 1983/03/14 | Labeling Revision | 016087 | 060 | AP | 1983/03/14 | Labeling Revision | 016087 | 059 | AP | 1983/03/14 | Labeling Revision | 016087 | 058 | AP | 1983/04/06 | Labeling Revision | 016087 | 057 | AP | 1983/03/01 | Manufacturing Change or Addition | 016087 | 056 | AP | 1982/10/29 | Control Supplement | 016087 | 054 | AP | 1982/08/20 | Control Supplement | 016087 | 053 | AP | 1982/10/27 | Manufacturing Change or Addition | 016087 | 052 | AP | 1982/05/18 | Control Supplement | 016087 | 051 | AP | 1982/08/05 | Labeling Revision | 016087 | 050 | AP | 1981/11/19 | Package Change | 016087 | 049 | AP | 1981/11/12 | Labeling Revision | 016087 | 048 | AP | 1981/11/13 | Labeling Revision | 016087 | 047 | AP | 1981/08/24 | Package Change | 016087 | 046 | AP | 1981/04/16 | Control Supplement | 016087 | 045 | AP | 1981/03/26 | Labeling Revision | 016087 | 044 | AP | 1981/04/16 | Manufacturing Change or Addition | 016087 | 043 | AP | 1981/04/20 | Manufacturing Change or Addition | 016087 | 042 | AP | 1980/05/19 | Labeling Revision | 016087 | 041 | AP | 1979/07/20 | Labeling Revision | 016087 | 040 | AP | 1979/11/02 | Labeling Revision | 016087 | 039 | AP | 1979/05/31 | Labeling Revision | 016087 | 038 | AP | 1979/04/09 | Manufacturing Change or Addition | 016087 | 037 | AP | 1979/03/23 | Labeling Revision | 016087 | 036 | AP | 1980/03/15 | Control Supplement | 016087 | 035 | AP | 1978/10/24 | Control Supplement | 016087 | 033 | AP | 1977/10/18 | Package Change | 016087 | 030 | AP | 1976/07/23 | Formulation Revision | 016087 | 029 | AP | 1976/04/23 | Package Change | 016087 | 028 | AP | 1975/11/13 | Control Supplement | 016087 | 027 | AP | 1975/05/01 | Control Supplement | 016087 | 026 | AP | 1974/12/02 | Control Supplement | 016087 | 025 | AP | 1974/11/15 | Control Supplement | 016087 | 023 | AP | 1974/06/05 | Labeling Revision | 016087 | 022 | AP | 1974/06/20 | Labeling Revision | 016087 | 000 | AP | 1966/08/24 | Approval |
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