DOPAMINE HYDROCHLORIDE 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	DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	80MG/100ML	Yes	Yes	AP	1983/09/30	1983/09/30	Prescription
002	DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	160MG/100ML	Yes	Yes	AP		1983/09/30	Prescription
003	DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	320MG/100ML	Yes	Yes	AP		1983/09/30	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
2014/05/14	SUPPL	45	Approval	Labeling	STANDARD	Label Letter
2013/12/16	SUPPL	44	Approval	Manufacturing (CMC)	STANDARD
2002/11/05	SUPPL	28	Approval	Manufacturing (CMC)	STANDARD
2001/04/10	SUPPL	27	Approval	Labeling	STANDARD	Review Letter
1999/06/05	SUPPL	26	Approval	Labeling	STANDARD
1998/11/16	SUPPL	25	Approval	Manufacturing (CMC)	STANDARD
1998/04/08	SUPPL	23	Approval	Labeling	STANDARD
1997/09/07	SUPPL	24	Approval	Manufacturing (CMC)	STANDARD
1996/06/26	SUPPL	20	Approval	Manufacturing (CMC)	STANDARD
1995/08/17	SUPPL	19	Approval	Manufacturing (CMC)	STANDARD
1995/08/03	SUPPL	22	Approval	Manufacturing (CMC)	STANDARD
1995/04/14	SUPPL	21	Approval	Labeling	STANDARD
1994/07/07	SUPPL	18	Approval	Labeling	STANDARD
1994/06/14	SUPPL	17	Approval	Manufacturing (CMC)	STANDARD
1992/05/07	SUPPL	16	Approval	Labeling
1991/12/31	SUPPL	15	Approval	Manufacturing (CMC)	STANDARD
1991/07/18	SUPPL	14	Approval	Manufacturing (CMC)	STANDARD
1990/11/15	SUPPL	13	Approval	Manufacturing (CMC)	STANDARD
1990/07/25	SUPPL	11	Approval	Manufacturing (CMC)	STANDARD
1987/08/13	SUPPL	10	Approval	Labeling
1986/10/29	SUPPL	9	Approval	Manufacturing (CMC)	STANDARD
1986/09/24	SUPPL	8	Approval	Manufacturing (CMC)	STANDARD
1986/04/01	SUPPL	7	Approval	Manufacturing (CMC)	STANDARD
1984/09/18	SUPPL	6	Approval	Manufacturing (CMC)	STANDARD
1984/09/18	SUPPL	5	Approval	Manufacturing (CMC)	STANDARD
1984/06/27	SUPPL	2	Approval	Manufacturing (CMC)	STANDARD
1984/01/04	SUPPL	3	Approval	Manufacturing (CMC)	STANDARD
1984/01/04	SUPPL	1	Approval	Manufacturing (CMC)	STANDARD
1983/09/30	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
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: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	RLD	RS	TE 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	RLD	RS	TE 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	RLD	RS	TE 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