产品信息
产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|
001 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No | None | 1983/08/30 | 1983/08/30 | Discontinued |
产品号 | 商品名 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 参比药物(RLD) | 生物等效参考标准(RS) | 治疗等效代码 | 该申请号批准日期 | 该产品号批准日期 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|
001 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No | None | 1983/08/30 | 1983/08/30 | Discontinued |
批准日期 | 申请类型 | 申请提交号 | 审查批准结论 | 申请内容分类 | 审评分类(优先审评;罕用药状态) | 通知信、综述、标签、说明书 | 备注 |
---|---|---|---|---|---|---|---|
2017/02/23 | SUPPL | 46 | Approval | Labeling | STANDARD | ||
2016/04/19 | SUPPL | 45 | Approval | Labeling | |||
2002/12/16 | SUPPL | 41 | Approval | Manufacturing (CMC) | |||
2002/09/05 | SUPPL | 40 | Approval | Labeling | |||
2001/08/14 | SUPPL | 38 | Approval | Labeling | |||
2001/02/21 | SUPPL | 39 | Approval | Manufacturing (CMC) | |||
1999/05/05 | SUPPL | 36 | Approval | Manufacturing (CMC) | |||
1998/10/20 | SUPPL | 34 | Approval | Labeling | |||
1998/10/20 | SUPPL | 33 | Approval | Manufacturing (CMC) | |||
1998/09/18 | SUPPL | 35 | Approval | Manufacturing (CMC) | |||
1995/03/21 | SUPPL | 32 | Approval | Manufacturing (CMC) | |||
1990/01/02 | SUPPL | 31 | Approval | Labeling | |||
1989/09/28 | SUPPL | 30 | Approval | Labeling | |||
1988/11/10 | SUPPL | 29 | Approval | Manufacturing (CMC) | |||
1987/07/15 | SUPPL | 26 | Approval | Manufacturing (CMC) | |||
1987/07/15 | SUPPL | 25 | Approval | Manufacturing (CMC) | |||
1987/07/15 | SUPPL | 24 | Approval | Manufacturing (CMC) | |||
1986/09/03 | SUPPL | 19 | Approval | Manufacturing (CMC) | |||
1986/04/18 | SUPPL | 20 | Approval | Manufacturing (CMC) | |||
1986/04/18 | SUPPL | 16 | Approval | Manufacturing (CMC) | |||
1984/10/30 | SUPPL | 15 | Approval | Manufacturing (CMC) | |||
1984/10/30 | SUPPL | 7 | Approval | Manufacturing (CMC) | |||
1984/10/30 | SUPPL | 6 | Approval | Manufacturing (CMC) | |||
1984/10/30 | SUPPL | 5 | Approval | Manufacturing (CMC) | |||
1984/10/30 | SUPPL | 4 | Approval | Manufacturing (CMC) | |||
1984/06/28 | SUPPL | 1 | Approval | Manufacturing (CMC) | |||
1983/08/30 | ORIG | 1 | Approval |
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
---|---|---|---|---|---|---|---|---|---|
无 |
关联产品号 | 独占权代码 | 失效日期 | 备注 |
---|---|---|---|
无 |