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 |
批准历史，通知信，药品说明书，综述等审批信息
| 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 |
