| 药品名称 | TALWIN | | 申请号 | 016194 | 产品号 | 001 | | 活性成分 | PENTAZOCINE LACTATE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 30MG BASE/ML | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | HOSPIRA 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 | | 016194 | 068 | AP | Letter | 2004/06/01 | 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 | | 016194 | 068 | AP | 2004/05/27 | Control Supplement | | 016194 | 065 | AP | 2001/09/26 | Control Supplement | | 016194 | 064 | AP | 2001/01/31 | Control Supplement | | 016194 | 063 | AP | 2000/06/27 | Control Supplement | | 016194 | 062 | AP | 2000/05/24 | Labeling Revision | | 016194 | 061 | AP | 1998/10/22 | Efficacy Supplement with Clinical Data to Support | | 016194 | 060 | AP | 1995/10/10 | Control Supplement | | 016194 | 059 | AP | 1993/04/21 | Control Supplement | | 016194 | 058 | AP | 1992/09/29 | Control Supplement | | 016194 | 057 | AP | 1990/01/25 | Manufacturing Change or Addition | | 016194 | 056 | AP | 1989/08/23 | Labeling Revision | | 016194 | 055 | AP | 1989/09/22 | Control Supplement | | 016194 | 053 | AP | 1988/05/04 | Control Supplement | | 016194 | 052 | AP | 1988/03/30 | Labeling Revision | | 016194 | 049 | AP | 1985/07/15 | Expiration Date Change | | 016194 | 048 | AP | 1983/08/24 | Package Change | | 016194 | 047 | AP | 1983/09/01 | Package Change | | 016194 | 045 | AP | 1983/05/18 | Labeling Revision | | 016194 | 044 | AP | 1981/03/18 | Manufacturing Change or Addition | | 016194 | 043 | AP | 1981/09/29 | Labeling Revision | | 016194 | 042 | AP | 1981/08/07 | Formulation Revision | | 016194 | 041 | AP | 1980/11/05 | Control Supplement | | 016194 | 040 | AP | 1981/10/09 | Labeling Revision | | 016194 | 039 | AP | 1979/04/09 | Labeling Revision | | 016194 | 038 | AP | 1978/07/18 | Control Supplement | | 016194 | 037 | AP | 1978/09/14 | Labeling Revision | | 016194 | 036 | AP | 1978/07/21 | Labeling Revision | | 016194 | 035 | AP | 1977/01/04 | Formulation Revision | | 016194 | 034 | AP | 1977/12/16 | Manufacturing Change or Addition | | 016194 | 033 | AP | 1977/12/02 | Manufacturing Change or Addition | | 016194 | 032 | AP | 1978/02/22 | Labeling Revision | | 016194 | 031 | AP | 1977/12/15 | Manufacturing Change or Addition | | 016194 | 030 | AP | 1976/06/07 | Manufacturing Change or Addition | | 016194 | 028 | AP | 1976/07/16 | Labeling Revision | | 016194 | 027 | AP | 1976/03/26 | Control Supplement | | 016194 | 025 | AP | 1975/10/23 | Labeling Revision | | 016194 | 024 | AP | 1974/10/25 | Labeling Revision | | 016194 | 021 | AP | 1974/02/06 | Labeling Revision | | 016194 | 018 | AP | 1976/03/26 | Control Supplement | | 016194 | 000 | AP | 1967/07/24 | Approval |
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