药品注册申请号：019685
申请类型：NDA (新药申请)
申请人：OTSUKA ICU MEDCL
申请人全名：OTSUKA ICU MEDICAL LLC
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 POTASSIUM CHLORIDE 5MEQ 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;104MG/100ML;600MG/100ML;310MG/100ML Yes No None 1988/10/17 1988/10/17 Discontinued
002 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 Yes No AP 1988/10/17 Prescription
003 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 Yes No None 1988/10/17 Discontinued
004 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 Yes No None 1988/10/17 Discontinued
005 POTASSIUM CHLORIDE 10MEQ 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;104MG/100ML;600MG/100ML;310MG/100ML Yes No None 1988/10/17 Discontinued
006 POTASSIUM CHLORIDE 10MEQ 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 Yes No None 1988/10/17 Discontinued
007 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 Yes No None 1988/10/17 Discontinued
008 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 Yes No None 1988/10/17 Discontinued
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
1988/10/17 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
2014/09/08 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2014/08/15 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2001/07/27 SUPPL-13（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1999/05/19 SUPPL-12（补充） Approval Labeling
1996/08/29 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-2（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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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 OTSUKA ICU MEDCL
更多信息
药品NDC数据与药品包装、标签说明书
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