药品注册申请号:090038
申请类型:ANDA (仿制药申请)
申请人:HIKMA FARMACEUTICA
申请人全名:HIKMA FARMACEUTICA (PORTUGAL) SA
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 PLASTIC CONTAINER MILRINONE LACTATE INJECTABLE;INJECTION EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) No No AP 2010/01/21 2010/01/21 Prescription
002 MILRINONE LACTATE IN PLASTIC CONTAINER MILRINONE LACTATE INJECTABLE;INJECTION EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) No No AP 2010/01/21 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;罕用药状态通知信、审评文件、说明书、包装标签备注
2010/01/21 ORIG-1(原始申请) Approval
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
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
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RLDRSTE 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 WEST-WARD PHARMS INT
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 PHARMA LTD
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RLDRSTE 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 WEST-WARD PHARMS INT
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 PHARMA LTD
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
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