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 |
2019/10/09 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/12/06 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/30 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/04/26 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2011/10/19 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2005/08/26 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2005/06/07 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/03 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/14 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/11/24 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/04/29 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/09/30 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/02/18 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/12/11 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/04/29 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/03/26 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/02/15 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/07/26 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/07/25 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/05/28 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/04/05 |
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;179MG/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 |
019367 |
004 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
019685 |
002 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
Yes |
No |
AP |
1988/10/17
|
ICU MEDICAL INC |
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;328MG/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 |
019367 |
005 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
019367 |
008 |
NDA |
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
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;254MG/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 |
019367 |
006 |
NDA |
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
019367 |
007 |
NDA |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
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;254MG/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 |
019367 |
006 |
NDA |
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
019367 |
007 |
NDA |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
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;328MG/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 |
019367 |
005 |
NDA |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |
019367 |
008 |
NDA |
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
INJECTABLE;INJECTION |
20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML |
Prescription |
No |
No |
AP |
1985/04/05
|
BAXTER HLTHCARE |