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 | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Yes | Yes | AP | 1982/03/23 | 1982/03/23 | Prescription |
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 | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Yes | Yes | AP | 1982/03/23 | 1982/03/23 | Prescription |
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 |
---|---|---|---|---|---|---|---|
2018/05/14 | SUPPL | 60 | Approval | Labeling | STANDARD | ||
2016/02/22 | SUPPL | 57 | Approval | Labeling | STANDARD | ||
2003/09/11 | SUPPL | 43 | Approval | Labeling | |||
2002/11/01 | SUPPL | 41 | Approval | Manufacturing (CMC) | STANDARD | ||
1999/07/16 | SUPPL | 40 | Approval | Labeling | |||
1999/05/27 | SUPPL | 38 | Approval | Labeling | |||
1998/12/01 | SUPPL | 37 | Approval | Manufacturing (CMC) | STANDARD | ||
1997/08/20 | SUPPL | 35 | Approval | Labeling | |||
1997/06/11 | SUPPL | 36 | Approval | Manufacturing (CMC) | STANDARD | ||
1997/03/28 | SUPPL | 34 | Approval | Manufacturing (CMC) | STANDARD | ||
1996/08/27 | SUPPL | 30 | Approval | Manufacturing (CMC) | STANDARD | ||
1996/08/06 | SUPPL | 33 | Approval | Manufacturing (CMC) | STANDARD | ||
1996/03/04 | SUPPL | 32 | Approval | Manufacturing (CMC) | STANDARD | ||
1995/08/18 | SUPPL | 31 | Approval | Manufacturing (CMC) | STANDARD | ||
1993/12/13 | SUPPL | 28 | Approval | Manufacturing (CMC) | STANDARD | ||
1993/01/21 | SUPPL | 26 | Approval | Manufacturing (CMC) | STANDARD | ||
1992/01/28 | SUPPL | 25 | Approval | Manufacturing (CMC) | STANDARD | ||
1991/09/10 | SUPPL | 24 | Approval | Manufacturing (CMC) | STANDARD | ||
1990/02/22 | SUPPL | 22 | Approval | Manufacturing (CMC) | STANDARD | ||
1990/01/11 | SUPPL | 23 | Approval | Manufacturing (CMC) | STANDARD | ||
1989/02/06 | SUPPL | 9 | Approval | Manufacturing (CMC) | STANDARD | ||
1986/11/26 | SUPPL | 19 | Approval | Manufacturing (CMC) | STANDARD | ||
1986/08/08 | SUPPL | 18 | Approval | Manufacturing (CMC) | STANDARD | ||
1986/06/25 | SUPPL | 5 | Approval | Labeling | |||
1986/06/25 | SUPPL | 4 | Approval | Manufacturing (CMC) | STANDARD | ||
1986/01/31 | SUPPL | 17 | Approval | Manufacturing (CMC) | STANDARD | ||
1985/10/29 | SUPPL | 11 | Approval | Manufacturing (CMC) | STANDARD | ||
1985/09/26 | SUPPL | 13 | Approval | Manufacturing (CMC) | STANDARD | ||
1985/03/11 | SUPPL | 14 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/11/28 | SUPPL | 10 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/10/22 | SUPPL | 15 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/10/17 | SUPPL | 7 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/09/08 | SUPPL | 16 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/03/21 | SUPPL | 6 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/03/01 | SUPPL | 1 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/02/17 | SUPPL | 3 | Approval | Manufacturing (CMC) | STANDARD | ||
1984/01/17 | SUPPL | 8 | Approval | Manufacturing (CMC) | STANDARD | ||
1982/07/26 | SUPPL | 2 | Approval | Manufacturing (CMC) | STANDARD | ||
1982/03/23 | ORIG | 1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
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 |
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
018561 | 001 | NDA | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Prescription | Yes | Yes | AP | 1982/03/23 | ICU MEDICAL INC |
019893 | 001 | NDA | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Prescription | Yes | Yes | AP | 1989/12/26 | ICU MEDICAL INC |
020047 | 003 | NDA | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Prescription | Yes | Yes | AP | 1991/07/02 | BAXTER HLTHCARE |
019626 | 005 | NDA | DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 70GM/100ML | Prescription | Yes | Yes | AP | 2015/02/18 | B BRAUN |