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 |
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|---|---|---|---|---|---|
| 2018/05/14 | SUPPL-60（补充） | Approval | Labeling | STANDARD | ||
| 2016/02/22 | SUPPL-57（补充） | Approval | Labeling | STANDARD | ||
| 2003/09/11 | SUPPL-43（补充） | Approval | Labeling | |||
| 2002/11/01 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/07/16 | SUPPL-40（补充） | Approval | Labeling | |||
| 1999/05/27 | SUPPL-38（补充） | Approval | Labeling | |||
| 1998/12/01 | SUPPL-37（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/08/20 | SUPPL-35（补充） | Approval | Labeling | |||
| 1997/06/11 | SUPPL-36（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/03/28 | SUPPL-34（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1996/08/27 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1996/08/06 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1996/03/04 | SUPPL-32（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1995/08/18 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1993/12/13 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1993/01/21 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1992/01/28 | SUPPL-25（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/09/10 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/02/22 | SUPPL-22（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/01/11 | SUPPL-23（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/02/06 | SUPPL-9（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/11/26 | SUPPL-19（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/08/08 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/06/25 | SUPPL-5（补充） | Approval | Labeling | |||
| 1986/06/25 | SUPPL-4（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/01/31 | SUPPL-17（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/10/29 | SUPPL-11（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/09/26 | SUPPL-13（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/03/11 | SUPPL-14（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/11/28 | SUPPL-10（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/10/22 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/10/17 | SUPPL-7（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/09/08 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/03/21 | SUPPL-6（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/03/01 | SUPPL-1（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/02/17 | SUPPL-3（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/01/17 | SUPPL-8（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/07/26 | SUPPL-2（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/03/23 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
