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 |
|---|
| 2021/11/03 |
SUPPL-50（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/08/22 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/02/13 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/09/27 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/07/23 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/03/08 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/03/12 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/04/11 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/05/04 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/09/25 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/07/21 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/04/26 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/12/29 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/08/29 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/09/18 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/04/13 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/11/21 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/26 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/05/05 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/12/21 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/03/25 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1988/02/24 |
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:CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/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 |
|---|
| 016679 |
001 |
NDA |
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 017608 |
001 |
NDA |
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 019634 |
003 |
NDA |
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1988/02/24
|
B BRAUN |
| 210332 |
001 |
ANDA |
DEXTROSE 5% AND LACTATED RINGER'S |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Discontinued |
No |
No |
AP |
2022/03/28
|
FRESENIUS KABI USA |
