| 药品名称 | ELIGARD | | 申请号 | 021343 | 产品号 | 001 | | 活性成分 | LEUPROLIDE ACETATE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;SUBCUTANEOUS | 规格 | 7.5MG/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2002/01/23 | 申请机构 | TOLMAR THERAPEUTICS INC
| | 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 | | 021343 | 033 | AP | Letter | 2016/03/02 | 下载 | | 021343 | 033 | AP | Label | 2016/03/03 | 下载 | | 021343 | 033 | AP | Review | 2016/08/05 | 下载 | | 021343 | 030 | AP | Letter | 2014/10/14 | 下载 | | 021343 | 030 | AP | Label | 2014/10/15 | 下载 | | 021343 | 027 | AP | Letter | 2013/03/01 | 下载 | | 021343 | 027 | AP | Label | 2013/03/01 | 下载 | | 021343 | 020 | AP | Label | 2011/04/11 | 下载 | | 021343 | 020 | AP | Letter | 2011/04/11 | 下载 | | 021343 | 019 | AP | Letter | 2011/01/20 | 下载 | | 021343 | 019 | AP | Label | 2011/01/20 | 下载 | | 021343 | 018 | AP | Label | 2010/10/12 | 下载 | | 021343 | 018 | AP | Letter | 2010/10/13 | 下载 | | 021343 | 015 | AP | Label | 2007/11/13 | 下载 | | 021343 | 015 | AP | Letter | 2007/11/19 | 下载 | | 021343 | 004 | AP | Letter | 2004/01/14 | 下载 | | 021343 | 002 | AP | Letter | 2003/07/08 | 下载 | | 021343 | 001 | AP | Letter | 2002/04/01 | 下载 | | 021343 | 000 | AP | Letter | 2002/01/23 | 下载 | | 021343 | 000 | AP | Label | 2002/01/23 | 下载 | | 021343 | 000 | AP | Review | 2002/01/23 | 下载 | | 021343 | 000 | AP | Other Important Information from FDA | 2011/12/20 | 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 | | 021343 | 033 | AP | 2016/02/29 | Labeling Revision | | 021343 | 032 | AP | 2015/10/26 | Manufacturing Change or Addition | | 021343 | 031 | AP | 2014/10/10 | Manufacturing Change or Addition | | 021343 | 030 | AP | 2014/10/10 | Labeling Revision | | 021343 | 029 | AP | 2014/05/30 | Manufacturing Change or Addition | | 021343 | 028 | AP | 2014/07/18 | Manufacturing Change or Addition | | 021343 | 027 | AP | 2013/02/27 | Labeling Revision | | 021343 | 026 | AP | 2013/04/09 | Manufacturing Change or Addition | | 021343 | 020 | AP | 2011/04/08 | Labeling Revision | | 021343 | 019 | AP | 2011/01/14 | Labeling Revision | | 021343 | 018 | AP | 2010/10/05 | Labeling Revision | | 021343 | 015 | AP | 2007/11/08 | Labeling Revision | | 021343 | 004 | AP | 2004/01/12 | Labeling Revision | | 021343 | 002 | AP | 2003/07/03 | Labeling Revision | | 021343 | 001 | AP | 2002/04/01 | Labeling Revision | | 021343 | 000 | AP | 2002/01/23 | Approval |
|