POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER-美国FDA药品数据库-药物在线

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 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;74.5MG/100ML;900MG/100ML	Yes	No	None	1988/03/24	1988/03/24	Discontinued
002	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;74.5MG/100ML;900MG/100ML	Yes	No	None		1988/03/24	Discontinued
003	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;900MG/100ML	Yes	No	None		1988/03/24	Discontinued
004	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;900MG/100ML	Yes	No	None		1988/03/24	Discontinued
005	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;900MG/100ML	Yes	Yes	AP		1988/03/24	Prescription
006	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;900MG/100ML	Yes	No	None		1988/03/24	Discontinued
007	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;900MG/100ML	Yes	No	None		1988/03/24	Discontinued
008	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;900MG/100ML	Yes	No	None		1988/03/24	Discontinued
009	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;900MG/100ML	Yes	Yes	AP		1988/03/24	Prescription

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
2014/09/08	SUPPL-34（补充）	Approval	Manufacturing (CMC)	STANDARD
2002/07/18	SUPPL-16（补充）	Approval	Labeling
1999/05/19	SUPPL-14（补充）	Approval	Labeling
1998/12/01	SUPPL-15（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/06/11	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
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-12（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/03/04	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
1988/03/24	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;900MG/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
019691	005	NDA	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;900MG/100ML	Prescription	Yes	Yes	AP	1988/03/24	ICU MEDICAL INC
213445	001	ANDA	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;900MG/100ML	Prescription	No	No	AP	2021/03/09	FRESENIUS KABI USA

活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;298MG/100ML;900MG/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
019691	009	NDA	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;900MG/100ML	Prescription	Yes	Yes	AP	1988/03/24	ICU MEDICAL INC
213445	002	ANDA	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;900MG/100ML	Prescription	No	No	AP	2021/03/09	FRESENIUS KABI USA