药品注册申请号：018365
申请类型：NDA (新药申请)
申请人：ICU MEDICAL INC
申请人全名：ICU MEDICAL INC
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 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;225MG/100ML Yes Yes AP 1980/05/29 Approved Prior to Jan 1, 1982 Prescription
002 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1983/07/05 Discontinued
003 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1983/07/05 Discontinued
004 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1983/07/05 Discontinued
005 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1988/03/28 Discontinued
006 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/03/28 Discontinued
007 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1988/03/28 Discontinued
008 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1988/03/28 Discontinued
009 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/03/28 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
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
2013/09/05 SUPPL-91（补充） Approval Manufacturing (CMC) STANDARD
2001/08/24 SUPPL-70（补充） Approval Labeling STANDARD
1999/01/22 SUPPL-69（补充） Approval Manufacturing (CMC) STANDARD
1998/10/29 SUPPL-68（补充） Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL-65（补充） Approval Labeling STANDARD
1997/06/11 SUPPL-66（补充） Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-61（补充） Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-60（补充） Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-63（补充） Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL-62（补充） Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-56（补充） Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-51（补充） Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-52（补充） Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1988/03/28 SUPPL-49（补充） Approval Labeling
1988/03/28 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL-46（补充） Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL-31（补充） Approval Labeling
1985/11/29 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL-40（补充） Approval Labeling
1985/10/26 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1984/11/09 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL-19（补充） Approval Labeling
1984/10/10 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1983/07/05 SUPPL-23（补充） Approval Labeling
1983/07/05 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1982/06/18 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1982/06/09 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1981/07/27 SUPPL-8（补充） Approval Labeling
1981/06/20 SUPPL-6（补充） Approval Labeling
1981/04/08 SUPPL-5（补充） Approval Labeling
1981/04/08 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1980/08/13 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1980/05/29 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:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;149MG/100ML;225MG/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
018365 001 NDA POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;225MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
212348 001 ANDA POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;225MG/100ML Prescription No No AP 2021/07/30 FRESENIUS KABI USA
212348 002 ANDA POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;149MG/100ML;225MG/100ML Prescription No No AP 2021/07/30 FRESENIUS KABI USA
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药品NDC数据与药品包装、标签说明书
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