| 药品名称 | NESACAINE | | 申请号 | 009435 | 产品号 | 001 | | 活性成分 | CHLOROPROCAINE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 1% | | 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 | FRESENIUS KABI USA LLC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
|
|
| 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 |
|
| 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 |
|
| 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 | | 009435 | 036 | AP | Label | 2010/02/25 | 下载 | | 009435 | 036 | AP | Letter | 2010/03/18 | 下载 | | 009435 | 035 | AP | Label | 2010/02/25 | 下载 | | 009435 | 035 | AP | Letter | 2010/03/18 | 下载 | | 009435 | 034 | AP | Label | 2004/06/22 | 下载 | | 009435 | 034 | AP | Letter | 2004/06/23 | 下载 |
|
| 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 | | 009435 | 040 | AP | 2013/02/16 | Manufacturing Change or Addition | | 009435 | 036 | AP | 2010/02/19 | Labeling Revision | | 009435 | 035 | AP | 2010/02/19 | Labeling Revision | | 009435 | 034 | AP | 2004/06/21 | Labeling Revision | | 009435 | 033 | AP | 2002/02/15 | Control Supplement | | 009435 | 032 | AP | 2000/11/10 | Labeling Revision | | 009435 | 031 | AP | 1996/05/31 | Manufacturing Change or Addition | | 009435 | 030 | AP | 1996/05/02 | Formulation Revision | | 009435 | 029 | AP | 1995/04/05 | Control Supplement | | 009435 | 028 | AP | 1993/04/13 | Control Supplement | | 009435 | 027 | AP | 1990/08/27 | Control Supplement | | 009435 | 026 | AP | 1990/03/05 | Manufacturing Change or Addition | | 009435 | 025 | AP | 1988/08/26 | Labeling Revision | | 009435 | 024 | AP | 1987/07/30 | Labeling Revision | | 009435 | 023 | AP | 1987/07/30 | Labeling Revision | | 009435 | 022 | AP | 1987/07/30 | Control Supplement | | 009435 | 021 | AP | 1986/08/06 | Manufacturing Change or Addition | | 009435 | 020 | AP | 1986/11/14 | Labeling Revision | | 009435 | 018 | AP | 1982/02/12 | Control Supplement | | 009435 | 017 | AP | 1982/02/12 | Control Supplement | | 009435 | 016 | AP | 1985/07/16 | Practioner Draft Labeling | | 009435 | 015 | AP | 1985/07/16 | Formulation Revision | | 009435 | 014 | AP | 1985/07/16 | Formulation Revision | | 009435 | 013 | AP | 1981/02/23 | Labeling Revision | | 009435 | 012 | AP | 1981/02/23 | Package Change | | 009435 | 010 | AP | 1979/06/13 | Control Supplement | | 009435 | 009 | AP | 1979/02/27 | Control Supplement | | 009435 | 008 | AP | 1980/11/06 | Labeling Revision | | 009435 | 007 | AP | 1974/11/15 | Control Supplement | | 009435 | 005 | AP | 1976/03/16 | Labeling Revision | | 009435 | 004 | AP | 1976/03/16 | Labeling Revision | | 009435 | 000 | AP | 1955/03/11 | Approval |
|