药品名称 | ARALEN | 申请号 | 006002 | 产品号 | 001 | 活性成分 | CHLOROQUINE PHOSPHATE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 300MG BASE | 治疗等效代码 | AA | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | SANOFI AVENTIS US LLC
| 化学类型 | | 审评分类 | |
|
|
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 | 006002 | 043 | AP | Label | 2013/11/08 | 下载 | 006002 | 043 | AP | Letter | 2013/11/08 | 下载 | 006002 | 042 | AP | Letter | 2009/06/17 | 下载 | 006002 | 039 | AP | Letter | 2003/06/22 | 下载 | 006002 | 039 | AP | Label | 2003/06/22 | 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 | 006002 | 043 | AP | 2013/11/06 | Labeling Revision | 006002 | 042 | AP | 2009/06/12 | Labeling Revision | 006002 | 040 | AP | 2002/04/30 | Control Supplement | 006002 | 039 | AP | 2003/06/13 | Labeling Revision | 006002 | 038 | AP | 2001/05/09 | Control Supplement | 006002 | 037 | AP | 1995/10/11 | Control Supplement | 006002 | 035 | AP | 1992/06/23 | Formulation Revision | 006002 | 034 | AP | 1992/03/11 | Manufacturing Change or Addition | 006002 | 033 | AP | 1991/05/17 | Control Supplement | 006002 | 032 | AP | 1993/02/18 | Labeling Revision | 006002 | 031 | AP | 1990/07/13 | Manufacturing Change or Addition | 006002 | 030 | AP | 1989/06/09 | Labeling Revision | 006002 | 028 | AP | 1987/06/18 | Manufacturing Change or Addition | 006002 | 027 | AP | 1987/03/27 | Labeling Revision | 006002 | 026 | AP | 1982/05/14 | Control Supplement | 006002 | 025 | AP | 1986/11/14 | Practioner Draft Labeling | 006002 | 024 | AP | 1986/10/14 | Practioner Draft Labeling | 006002 | 023 | AP | 1981/05/15 | Package Change | 006002 | 022 | AP | 1981/05/15 | Package Change | 006002 | 021 | AP | 1980/08/08 | Manufacturing Change or Addition | 006002 | 020 | AP | 1980/01/08 | Package Change | 006002 | 018 | AP | 1978/05/22 | Manufacturing Change or Addition | 006002 | 017 | AP | 1976/04/12 | Control Supplement | 006002 | 016 | AP | 1976/03/31 | Labeling Revision | 006002 | 015 | AP | 1975/01/29 | Control Supplement | 006002 | 000 | AP | 1949/10/31 | Approval |
|