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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1986/01/17 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2014/08/15 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/12/13 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1997/08/21 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/06/11 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/27 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/01/28 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/09/10 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/02/22 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/01/11 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/06/22 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/06/14 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/11/26 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/08/08 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/05/13 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
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; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE; 剂型/给药途径:SOLUTION;IRRIGATION; 规格:20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML; 治疗等效代码:AT<<<
| 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 |
|---|
| 018494 |
001 |
NDA |
LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
SOLUTION;IRRIGATION |
20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AT |
1982/02/19
|
BAXTER HLTHCARE |
| 018681 |
001 |
NDA |
LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
SOLUTION;IRRIGATION |
20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
Yes |
Yes |
AT |
1982/12/27
|
B BRAUN |
| 018921 |
001 |
NDA |
LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
SOLUTION;IRRIGATION |
20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
Yes |
Yes |
AT |
1984/04/03
|
BAXTER HLTHCARE |
| 019416 |
001 |
NDA |
LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
SOLUTION;IRRIGATION |
20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
Yes |
Yes |
AT |
1986/01/17
|
OTSUKA ICU MEDCL |