| 药品名称 | KADIAN | | 申请号 | 020616 | 产品号 | 006 | | 活性成分 | MORPHINE SULFATE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE, EXTENDED RELEASE;ORAL | 规格 | 80MG | | 治疗等效代码 | AB | 参比药物 | 否 | | 批准日期 | 2006/10/27 | 申请机构 | ALLERGAN SALES LLC
| | 化学类型 | New dosage form | 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 | | 020616 | 058 | AP | Letter | 2016/10/04 | 下载 | | 020616 | 055 | AP | Letter | 2016/04/22 | 下载 | | 020616 | 054 | AP | Letter | 2015/07/02 | 下载 | | 020616 | 053 | AP | Letter | 2014/08/20 | 下载 | | 020616 | 051 | AP | Label | 2014/04/16 | 下载 | | 020616 | 051 | AP | Letter | 2014/04/17 | 下载 | | 020616 | 048 | AP | Letter | 2013/03/29 | 下载 | | 020616 | 047 | AP | Letter | 2013/04/17 | 下载 | | 020616 | 044 | AP | Label | 2012/07/13 | 下载 | | 020616 | 041 | AP | Letter | 2012/07/11 | 下载 | | 020616 | 041 | AP | Label | 2012/07/12 | 下载 | | 020616 | 025 | AP | Label | 2007/04/25 | 下载 | | 020616 | 025 | AP | Letter | 2007/05/01 | 下载 | | 020616 | 022 | AP | Label | 2006/11/06 | 下载 | | 020616 | 022 | AP | Letter | 2006/11/06 | 下载 | | 020616 | 021 | AP | Review | 2007/11/19 | 下载 | | 020616 | 021 | AP | Letter | 2007/03/07 | 下载 | | 020616 | 021 | AP | Label | 2007/03/07 | 下载 | | 020616 | 017 | AP | Label | 2007/03/07 | 下载 | | 020616 | 017 | AP | Review | 2007/11/19 | 下载 | | 020616 | 017 | AP | Letter | 2007/03/07 | 下载 | | 020616 | 010 | AP | Label | 2005/09/30 | 下载 | | 020616 | 010 | AP | Letter | 2005/10/20 | 下载 | | 020616 | 001 | AP | Review | 2011/02/04 | 下载 | | 020616 | 000 | AP | Medication Guide | 2012/07/11 | 下载 | | 020616 | 000 | AP | Other | 2012/07/11 | 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 | | 020616 | 058 | AP | 2016/09/30 | Supplement | | 020616 | 055 | AP | 2016/04/20 | Supplement | | 020616 | 054 | AP | 2015/06/26 | Supplement | | 020616 | 053 | AP | 2014/08/19 | Supplement | | 020616 | 052 | AP | 2014/04/14 | Manufacturing Change or Addition | | 020616 | 051 | AP | 2014/04/16 | Labeling Revision | | 020616 | 048 | AP | 2013/03/27 | Labeling Revision | | 020616 | 047 | AP | 2013/04/15 | Labeling Revision | | 020616 | 046 | AP | 2013/01/14 | Manufacturing Change or Addition | | 020616 | 044 | AP | 2012/07/09 | Manufacturing Change or Addition | | 020616 | 041 | AP | 2012/07/09 | Labeling Revision | | 020616 | 036 | AP | 2012/07/09 | Labeling Revision | | 020616 | 025 | AP | 2007/04/20 | Formulation Revision | | 020616 | 022 | AP | 2006/10/27 | Formulation Revision | | 020616 | 021 | AP | 2007/02/27 | Labeling Revision | | 020616 | 017 | AP | 2007/02/27 | Formulation Revision | | 020616 | 010 | AP | 2005/09/28 | Package Change | | 020616 | 009 | AP | 2002/03/28 | Control Supplement | | 020616 | 008 | AP | 2001/12/18 | Control Supplement | | 020616 | 007 | AP | 2001/12/21 | Control Supplement | | 020616 | 006 | AP | 2001/02/08 | Manufacturing Change or Addition | | 020616 | 005 | AP | 2000/02/28 | Formulation Revision | | 020616 | 004 | AP | 2001/03/09 | Control Supplement | | 020616 | 003 | AP | 1999/07/16 | Labeling Revision | | 020616 | 002 | AP | 1998/04/08 | Package Change | | 020616 | 001 | AP | 1997/07/29 | Labeling Revision | | 020616 | 000 | AP | 1996/07/03 | Approval |
|