MILRINONE LACTATE IN DEXTROSE 5% 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	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	No	Yes	AP	2002/05/28	2002/05/28	Prescription
002	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	No	Yes	AP	2002/05/28	2002/05/28	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

>>>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
2002/05/28	ORIG-1（原始申请）	Approval			Label Review Letter

>>>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
2008/02/27	SUPPL-6（补充）	Approval	Labeling
2004/03/24	SUPPL-2（补充）	Approval	Labeling

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:MILRINONE LACTATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML); 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
075834	001	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	Prescription	No	Yes	AP	2002/05/28	BAXTER HLTHCARE
075885	001	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	Discontinued	No	No	AP	2002/05/28	HOSPIRA
078113	001	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2008/05/21	HIKMA
090038	001	ANDA	MILRINONE LACTATE IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2010/01/21	HIKMA FARMACEUTICA
213585	001	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2020/07/16	GLAND
209666	001	ANDA	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2020/09/03	EUGIA PHARMA

>>>活性成分:MILRINONE LACTATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML); 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
075834	002	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Prescription	No	Yes	AP	2002/05/28	BAXTER HLTHCARE
075885	002	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Discontinued	No	No	AP	2002/05/28	HOSPIRA
077151	002	ANDA	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Discontinued	No	No	AP	2005/07/20	WOODWARD
078113	002	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2008/05/21	HIKMA
090038	002	ANDA	MILRINONE LACTATE IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2010/01/21	HIKMA FARMACEUTICA
213585	002	ANDA	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2020/07/16	GLAND
209666	002	ANDA	MILRINONE LACTATE IN DEXTROSE 5%	MILRINONE LACTATE	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	Prescription	No	No	AP	2020/09/03	EUGIA PHARMA