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 |
|---|
| 2019/08/22 |
SUPPL-103（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/08/22 |
SUPPL-102（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/10/31 |
SUPPL-101（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/09/10 |
SUPPL-100（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/06/02 |
SUPPL-94（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/08/14 |
SUPPL-92（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/11/29 |
SUPPL-90（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/11/24 |
SUPPL-91（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/04/29 |
SUPPL-89（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/10/11 |
SUPPL-88（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/09/30 |
SUPPL-86（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/02/18 |
SUPPL-87（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/04/29 |
SUPPL-83（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/03/26 |
SUPPL-82（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/02/15 |
SUPPL-81（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/26 |
SUPPL-80（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/01/12 |
SUPPL-79（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/07/25 |
SUPPL-78（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/05/28 |
SUPPL-77（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/28 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/08/28 |
SUPPL-66（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/07/03 |
SUPPL-73（补充） |
Approval |
Labeling |
|
|
|
| 1985/06/13 |
SUPPL-71（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/04/15 |
SUPPL-74（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/01/24 |
SUPPL-64（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/09/22 |
SUPPL-70（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/16 |
SUPPL-65（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/02/28 |
SUPPL-69（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/07/11 |
SUPPL-61（补充） |
Approval |
Labeling |
|
|
|
| 1982/06/03 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/04/16 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/02/16 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/12/21 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/20 |
SUPPL-60（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/09 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/10/23 |
SUPPL-53（补充） |
Approval |
Labeling |
|
|
|
| 1981/10/23 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/08/26 |
SUPPL-55（补充） |
Approval |
Labeling |
|
|
|
| 1981/06/29 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/04/16 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/21 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/07 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/08/06 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/07/31 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/28 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/06/18 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/05/30 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/02/25 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/08/02 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/10/20 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/10/12 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/08/07 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/08/02 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/06/20 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/04/25 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 1978/03/24 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/03/22 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/02/28 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/12/14 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/06/06 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/02/07 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/10/29 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1976/07/13 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1976/07/01 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/06/17 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/05/11 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1976/01/05 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/01/02 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1975/09/25 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/09/23 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/09/17 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/07/10 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1971/03/22 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 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 |
与本品治疗等效的药品
活性成分:DEXTROSE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;450MG/100ML 治疗等效代码:AP
| 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 |
|---|
| 016683 |
001 |
NDA |
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 017607 |
001 |
NDA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 019631 |
009 |
NDA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
No |
No |
AP |
1988/02/24
|
B BRAUN |
| 211276 |
001 |
ANDA |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% |
DEXTROSE; SODIUM CHLORIDE |
INJECTABLE;INJECTION |
5GM/100ML;450MG/100ML |
Prescription |
No |
No |
AP |
2020/09/15
|
FRESENIUS KABI USA |
