药品名称 | DEMEROL | 申请号 | 005010 | 产品号 | 009 | 活性成分 | MEPERIDINE HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 75MG/ML | 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 | US PHARMACEUTICAL HOLDINGS II LLC
| 化学类型 | New molecular entity (NME) | 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 | 005010 | 051 | AP | Letter | 2011/11/02 | 下载![](pdf.jpg) | 005010 | 051 | AP | Label | 2011/10/31 | 下载![](pdf.jpg) | 005010 | 050 | AP | Label | 2011/04/11 | 下载![](pdf.jpg) | 005010 | 050 | AP | Letter | 2011/04/13 | 下载![](pdf.jpg) | 005010 | 049 | AP | Letter | 2009/03/10 | 下载![](pdf.jpg) | 005010 | 049 | AP | Label | 2009/03/17 | 下载![](pdf.jpg) | 005010 | 048 | AP | Letter | 2003/06/08 | 下载![](pdf.jpg) | 005010 | 047 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) |
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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 | 005010 | 051 | AP | 2011/10/31 | Labeling Revision | 005010 | 050 | AP | 2011/04/11 | Labeling Revision | 005010 | 049 | AP | 2009/03/05 | Labeling Revision | 005010 | 048 | AP | 2003/05/15 | Labeling Revision | 005010 | 047 | AP | 2003/02/26 | Labeling Revision | 005010 | 046 | AP | 2000/10/17 | Control Supplement | 005010 | 045 | AP | 1995/10/10 | Control Supplement | 005010 | 044 | AP | 1995/03/16 | Package Change | 005010 | 043 | AP | 1995/03/16 | Control Supplement | 005010 | 042 | AP | 1995/03/16 | Package Change | 005010 | 041 | AP | 1992/09/10 | Control Supplement | 005010 | 040 | AP | 1992/09/29 | Control Supplement | 005010 | 039 | AP | 1992/09/29 | Control Supplement | 005010 | 038 | AP | 1992/07/30 | Package Change | 005010 | 037 | AP | 1991/02/12 | Manufacturing Change or Addition | 005010 | 036 | AP | 1990/09/12 | Manufacturing Change or Addition | 005010 | 035 | AP | 1990/01/25 | Manufacturing Change or Addition | 005010 | 034 | AP | 1989/05/24 | Manufacturing Change or Addition | 005010 | 033 | AP | 1989/05/25 | Manufacturing Change or Addition | 005010 | 032 | AP | 1989/04/03 | Package Change | 005010 | 031 | AP | 1997/07/24 | Labeling Revision | 005010 | 030 | AP | 1988/01/06 | Labeling Revision | 005010 | 029 | AP | 1986/07/18 | Labeling Revision | 005010 | 028 | AP | 1986/05/12 | Control Supplement | 005010 | 027 | AP | 1985/06/04 | Control Supplement | 005010 | 026 | AP | 1985/05/20 | Manufacturing Change or Addition | 005010 | 025 | AP | 1985/05/20 | Control Supplement | 005010 | 024 | AP | 1984/01/17 | Control Supplement | 005010 | 023 | AP | 1983/03/28 | Control Supplement | 005010 | 022 | AP | 1983/03/28 | Labeling Revision | 005010 | 021 | AP | 1983/03/28 | Control Supplement | 005010 | 020 | AP | 1983/03/28 | Control Supplement | 005010 | 019 | AP | 1983/03/28 | Package Change | 005010 | 018 | AP | 1983/03/28 | Package Change | 005010 | 017 | AP | 1982/09/07 | Control Supplement | 005010 | 014 | AP | 1979/07/26 | Labeling Revision | 005010 | 013 | AP | 1978/07/21 | Labeling Revision | 005010 | 012 | AP | 1978/07/27 | Labeling Revision | 005010 | 011 | AP | 1977/12/02 | Control Supplement | 005010 | 010 | AP | 1978/01/04 | Manufacturing Change or Addition | 005010 | 009 | AP | 1976/08/10 | Formulation Revision | 005010 | 008 | AP | 1976/05/04 | Labeling Revision | 005010 | 004 | AP | 1974/01/18 | Labeling Revision | 005010 | 000 | AP | 1942/11/10 | Approval |
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