| 药品名称 | STADOL | | 申请号 | 017857 | 产品号 | 004 | | 活性成分 | BUTORPHANOL TARTRATE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 2MG/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 | APOTHECON INC DIV BRISTOL MYERS SQUIBB
| | 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 | | 无 |
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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 | | 017857 | 058 | AP | 2001/11/05 | Manufacturing Change or Addition | | 017857 | 054 | AP | 1999/05/25 | Labeling Revision | | 017857 | 053 | AP | 1998/03/13 | Labeling Revision | | 017857 | 051 | AP | 1998/03/13 | Labeling Revision | | 017857 | 050 | AP | 1993/04/16 | Labeling Revision | | 017857 | 049 | AP | 1993/04/16 | Labeling Revision | | 017857 | 048 | AP | 1992/05/01 | Labeling Revision | | 017857 | 047 | AP | 1990/09/19 | Manufacturing Change or Addition | | 017857 | 044 | AP | 1988/12/12 | Control Supplement | | 017857 | 043 | AP | 1987/08/04 | Labeling Revision | | 017857 | 042 | AP | 1987/01/14 | Control Supplement | | 017857 | 041 | AP | 1986/10/20 | Control Supplement | | 017857 | 039 | AP | 1987/03/05 | New Dosage Regimen | | 017857 | 037 | AP | 1985/01/10 | Package Change | | 017857 | 036 | AP | 1985/07/22 | Manufacturing Change or Addition | | 017857 | 035 | AP | 1984/10/19 | Labeling Revision | | 017857 | 034 | AP | 1984/06/07 | Labeling Revision | | 017857 | 033 | AP | 1984/06/07 | Labeling Revision | | 017857 | 032 | AP | 1984/05/09 | Labeling Revision | | 017857 | 031 | AP | 1984/04/16 | Labeling Revision | | 017857 | 030 | AP | 1984/04/04 | Labeling Revision | | 017857 | 029 | AP | 1984/10/24 | Control Supplement | | 017857 | 027 | AP | 1984/05/07 | Control Supplement | | 017857 | 026 | AP | 1984/01/17 | Labeling Revision | | 017857 | 025 | AP | 1983/09/07 | Labeling Revision | | 017857 | 024 | AP | 1983/04/20 | Control Supplement | | 017857 | 023 | AP | 1983/04/20 | Control Supplement | | 017857 | 022 | AP | 1982/02/26 | Patient Population Altered | | 017857 | 020 | AP | 1981/05/14 | Labeling Revision | | 017857 | 019 | AP | 1981/05/14 | Labeling Revision | | 017857 | 016 | AP | 1981/09/02 | Expiration Date Change | | 017857 | 015 | AP | 1980/06/03 | Control Supplement | | 017857 | 013 | AP | 1987/08/04 | Control Supplement | | 017857 | 012 | AP | 1987/08/04 | Control Supplement | | 017857 | 011 | AP | 1979/05/15 | Package Change | | 017857 | 010 | AP | 1982/09/07 | Manufacturing Change or Addition | | 017857 | 009 | AP | 1979/11/20 | Labeling Revision | | 017857 | 007 | AP | 1979/11/20 | Labeling Revision | | 017857 | 006 | AP | 1979/11/20 | Labeling Revision | | 017857 | 005 | AP | 1979/11/20 | Labeling Revision | | 017857 | 004 | AP | 1978/09/14 | Package Change | | 017857 | 003 | AP | 1978/09/14 | Formulation Revision | | 017857 | 002 | AP | 1978/09/14 | Formulation Revision | | 017857 | 001 | AP | 1978/09/14 | Labeling Revision | | 017857 | 000 | AP | 1978/08/22 | Approval |
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