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 10% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 10GM/100ML | Yes | Yes | AP | 1971/01/25 | Approved Prior to Jan 1, 1982 | 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 |
|---|---|---|---|---|---|---|
| 2020/08/12 | SUPPL-127（补充） | Approval | Manufacturing (CMC) | N/A | ||
| 2019/08/05 | SUPPL-121（补充） | Approval | Labeling | STANDARD | ||
| 2016/01/15 | SUPPL-123（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2014/12/22 | SUPPL-119（补充） | Approval | Labeling | STANDARD | ||
| 2014/05/23 | SUPPL-120（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2006/07/10 | SUPPL-113（补充） | Approval | Labeling | |||
| 2005/02/04 | SUPPL-108（补充） | Approval | Labeling | |||
| 2003/05/15 | SUPPL-107（补充） | Approval | Labeling | |||
| 2001/08/29 | SUPPL-105（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/08/14 | SUPPL-104（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 2001/08/14 | SUPPL-103（补充） | Approval | Labeling | |||
| 2000/01/28 | SUPPL-102（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1999/09/15 | SUPPL-98（补充） | Approval | Labeling | |||
| 1999/07/30 | SUPPL-101（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1998/05/27 | SUPPL-100（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1997/04/29 | SUPPL-99（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1994/09/30 | SUPPL-96（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1994/03/17 | SUPPL-95（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1994/02/18 | SUPPL-97（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/04/29 | SUPPL-93（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/03/26 | SUPPL-92（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1991/02/15 | SUPPL-90（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1990/07/30 | SUPPL-91（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/07/26 | SUPPL-89（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1989/01/12 | SUPPL-88（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/07/25 | SUPPL-87（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1987/05/28 | SUPPL-86（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1986/02/27 | SUPPL-83（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/08/28 | SUPPL-74（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/08/28 | SUPPL-73（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/06/13 | SUPPL-81（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/04/10 | SUPPL-82（补充） | Approval | Labeling | |||
| 1985/01/24 | SUPPL-71（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1985/01/24 | SUPPL-56（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/09/22 | SUPPL-80（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/06/07 | SUPPL-77（补充） | Approval | Labeling | |||
| 1984/06/07 | SUPPL-76（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/04/13 | SUPPL-79（补充） | Approval | Labeling | |||
| 1984/03/16 | SUPPL-72（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1984/02/28 | SUPPL-78（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1983/07/11 | SUPPL-68（补充） | Approval | Labeling | |||
| 1982/06/03 | SUPPL-65（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/04/16 | SUPPL-61（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/03/23 | SUPPL-58（补充） | Approval | Labeling | |||
| 1982/03/23 | SUPPL-57（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1982/02/16 | SUPPL-69（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/12/21 | SUPPL-59（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/11/20 | SUPPL-67（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/11/09 | SUPPL-64（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/08/26 | SUPPL-60（补充） | Approval | Labeling | |||
| 1981/06/29 | SUPPL-55（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/04/16 | SUPPL-49（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1981/01/21 | SUPPL-54（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/12/15 | SUPPL-53（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/12/15 | SUPPL-52（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/08/07 | SUPPL-45（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/08/06 | SUPPL-50（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/07/31 | SUPPL-51（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/06/28 | SUPPL-41（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/06/18 | SUPPL-47（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/05/30 | SUPPL-46（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/03/18 | SUPPL-43（补充） | Approval | Labeling | |||
| 1980/03/18 | SUPPL-42（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1980/02/25 | SUPPL-32（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1979/08/02 | SUPPL-40（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/10/20 | SUPPL-37（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/10/12 | SUPPL-38（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/08/07 | SUPPL-36（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/08/02 | SUPPL-35（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/06/20 | SUPPL-31（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/04/25 | SUPPL-34（补充） | Approval | Labeling | |||
| 1978/03/24 | SUPPL-30（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/03/22 | SUPPL-33（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1978/02/28 | SUPPL-29（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/12/14 | SUPPL-28（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/06/06 | SUPPL-27（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1977/02/07 | SUPPL-26（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/10/18 | SUPPL-19（补充） | Approval | Labeling | |||
| 1976/07/13 | SUPPL-25（补充） | Approval | Labeling | |||
| 1976/07/01 | SUPPL-21（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/06/17 | SUPPL-24（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/05/11 | SUPPL-17（补充） | Approval | Labeling | |||
| 1976/01/05 | SUPPL-20（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1976/01/02 | SUPPL-22（补充） | Approval | Labeling | |||
| 1975/09/23 | SUPPL-18（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1975/09/17 | SUPPL-16（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1975/07/10 | SUPPL-13（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1975/06/16 | SUPPL-15（补充） | Approval | Manufacturing (CMC) | STANDARD | ||
| 1971/01/25 | ORIG-1（原始申请） | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
