药品名称 | INDERIDE-40/25 | 申请号 | 018031 | 产品号 | 001 | 活性成分 | HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | WYETH PHARMACEUTICALS INC
| 化学类型 | New combination | 审评分类 | Standard 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 | 018031 | 038 | AP | Label | 2011/03/21 | 下载 | 018031 | 038 | AP | Letter | 2011/03/23 | 下载 | 018031 | 037 | AP | Letter | 2011/03/23 | 下载 | 018031 | 037 | AP | Label | 2011/03/21 | 下载 | 018031 | 036 | AP | Label | 2010/03/05 | 下载 | 018031 | 036 | AP | Letter | 2010/03/08 | 下载 | 018031 | 035 | AP | Label | 2008/01/08 | 下载 | 018031 | 035 | AP | Letter | 2008/01/09 | 下载 | 018031 | 034 | AP | Letter | 2007/03/06 | 下载 | 018031 | 033 | AP | Letter | 2007/01/08 | 下载 | 018031 | 032 | AP | Letter | 2004/06/10 | 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 | 018031 | 038 | AP | 2011/03/17 | Labeling Revision | 018031 | 037 | AP | 2011/03/17 | Labeling Revision | 018031 | 036 | AP | 2010/03/04 | Labeling Revision | 018031 | 035 | AP | 2008/01/02 | Labeling Revision | 018031 | 034 | AP | 2007/02/21 | Labeling Revision | 018031 | 033 | AP | 2006/12/29 | Labeling Revision | 018031 | 032 | AP | 2004/06/09 | Labeling Revision | 018031 | 031 | AP | 2001/05/03 | Labeling Revision | 018031 | 030 | AP | 2001/11/01 | Labeling Revision | 018031 | 029 | AP | 1997/11/07 | Labeling Revision | 018031 | 028 | AP | 1994/06/14 | Manufacturing Change or Addition | 018031 | 027 | AP | 1989/08/09 | Package Change | 018031 | 026 | AP | 1989/04/12 | Package Change | 018031 | 025 | AP | 1989/07/10 | Control Supplement | 018031 | 024 | AP | 1988/11/07 | Labeling Revision | 018031 | 023 | AP | 1988/05/25 | Package Change | 018031 | 022 | AP | 1986/12/30 | Expiration Date Change | 018031 | 021 | AP | 1986/10/08 | Formulation Revision | 018031 | 021 | AP | 1987/01/20 | Package Change | 018031 | 019 | AP | 1986/07/24 | Control Supplement | 018031 | 018 | AP | 1990/02/08 | New Dosage Regimen | 018031 | 017 | AP | 1990/02/08 | Practioner Draft Labeling | 018031 | 016 | AP | 1985/02/22 | Manufacturing Change or Addition | 018031 | 015 | AP | 1983/08/11 | Control Supplement | 018031 | 013 | AP | 1982/08/23 | Formulation Revision | 018031 | 012 | AP | 1982/06/09 | Control Supplement | 018031 | 011 | AP | 1982/04/28 | Labeling Revision | 018031 | 010 | AP | 1982/01/26 | Manufacturing Change or Addition | 018031 | 009 | AP | 1982/03/03 | Manufacturing Change or Addition | 018031 | 008 | AP | 1980/09/19 | Formulation Revision | 018031 | 007 | AP | 1982/04/12 | Control Supplement | 018031 | 006 | AP | 1981/01/27 | Control Supplement | 018031 | 005 | AP | 1980/10/03 | Control Supplement | 018031 | 004 | AP | 1980/03/27 | Expiration Date Change | 018031 | 003 | AP | 1980/05/28 | Control Supplement | 018031 | 002 | AP | 1981/12/10 | Control Supplement | 018031 | 001 | AP | 1979/07/31 | Package Change | 018031 | 000 | AP | 1979/06/15 | Approval |
|