药品注册申请号:019099
申请类型:NDA (新药申请)
申请人:B BRAUN
申请人全名:B BRAUN 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 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 40MG/100ML Yes Yes None 1986/10/15 1986/10/15 Prescription
002 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/100ML Yes Yes AP 1986/10/15 Prescription
003 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 160MG/100ML Yes Yes AP 1986/10/15 Prescription
004 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 320MG/100ML Yes Yes AP 1986/10/15 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2013/03/19 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2005/01/04 SUPPL 8 Approval Labeling STANDARD
2002/09/17 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL 6 Approval Labeling STANDARD
1996/02/07 SUPPL 5 Approval Labeling STANDARD
1990/10/04 SUPPL 4 Approval Labeling
1988/01/20 SUPPL 2 Approval Labeling
1987/01/15 SUPPL 1 Approval Labeling
1986/10/15 ORIG 1 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
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:DOPAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:80MG/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
018132 002 NDA DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/100ML Prescription Yes Yes AP 1982/02/04 HOSPIRA
018826 001 NDA DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/100ML Prescription Yes Yes AP 1983/09/30 HOSPIRA
019099 002 NDA DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/100ML Prescription Yes Yes AP 1986/10/15 B BRAUN
019615 001 NDA DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/100ML Prescription Yes Yes AP 1987/03/27 BAXTER HLTHCARE
活性成分:DOPAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:160MG/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
018132 003 NDA DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 160MG/100ML Prescription Yes Yes AP 1982/02/04 HOSPIRA
018826 002 NDA DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 160MG/100ML Prescription Yes Yes AP 1983/09/30 HOSPIRA
019099 003 NDA DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 160MG/100ML Prescription Yes Yes AP 1986/10/15 B BRAUN
019615 002 NDA DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 160MG/100ML Prescription Yes Yes AP 1987/03/27 BAXTER HLTHCARE
活性成分:DOPAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:320MG/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
018826 003 NDA DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 320MG/100ML Prescription Yes Yes AP 1983/09/30 HOSPIRA
019099 004 NDA DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 320MG/100ML Prescription Yes Yes AP 1986/10/15 B BRAUN
019615 003 NDA DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 320MG/100ML Prescription Yes Yes AP 1987/03/27 BAXTER HLTHCARE
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