| 药品名称 | ADALAT CC | | 申请号 | 020198 | 产品号 | 001 | | 活性成分 | NIFEDIPINE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 30MG | | 治疗等效代码 | AB1 | 参比药物 | 否 | | 批准日期 | 1993/04/21 | 申请机构 | ALVOGEN GROUP HOLDINGS LLC
| | 化学类型 | New formulation or new manufacturer | 审评分类 | Standard review drug |
|
|
|
| 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 | | 020198 | 023 | AP | Label | 2011/02/28 | 下载 | | 020198 | 023 | AP | Letter | 2011/03/02 | 下载 | | 020198 | 022 | AP | Label | 2010/03/05 | 下载 | | 020198 | 022 | AP | Letter | 2010/03/08 | 下载 | | 020198 | 017 | AP | Letter | 2005/04/06 | 下载 | | 020198 | 017 | AP | Label | 2005/04/06 | 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 | | 020198 | 026 | AP | 2016/08/29 | Manufacturing Change or Addition | | 020198 | 025 | AP | 2016/05/17 | Manufacturing Change or Addition | | 020198 | 024 | AP | 2015/03/09 | Manufacturing Change or Addition | | 020198 | 023 | AP | 2011/02/28 | Labeling Revision | | 020198 | 022 | AP | 2010/03/03 | Labeling Revision | | 020198 | 017 | AP | 2005/04/01 | Labeling Revision | | 020198 | 012 | AP | 1999/04/13 | Manufacturing Change or Addition | | 020198 | 010 | AP | 1998/12/18 | Manufacturing Change or Addition | | 020198 | 009 | AP | 1996/07/23 | Manufacturing Change or Addition | | 020198 | 008 | AP | 1996/03/14 | Manufacturing Change or Addition | | 020198 | 007 | AP | 1996/01/24 | Package Change | | 020198 | 006 | AP | 1995/06/14 | Manufacturing Change or Addition | | 020198 | 005 | AP | 1996/03/29 | Package Change | | 020198 | 004 | AP | 1994/07/28 | Package Change | | 020198 | 003 | AP | 1994/07/07 | Labeling Revision | | 020198 | 002 | AP | 1993/12/06 | Control Supplement | | 020198 | 001 | AP | 1993/07/23 | Labeling Revision | | 020198 | 000 | AP | 1993/04/21 | Approval |
|