药品注册申请号:018132
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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 DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 40MG/ML Yes Yes AP 1981/05/19 Approved Prior to Jan 1, 1982 Prescription
002 DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/100ML Yes Yes AP 1982/02/04 Prescription
003 DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 160MG/100ML Yes Yes AP 1982/02/04 Prescription
004 DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/ML Yes Yes AP 1982/07/09 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
2014/05/14 SUPPL 67 Approval Labeling STANDARD
2008/07/02 SUPPL 59 Approval Labeling
2002/10/25 SUPPL 51 Approval Manufacturing (CMC)
2001/03/22 SUPPL 50 Approval Manufacturing (CMC)
2001/03/22 SUPPL 49 Approval Manufacturing (CMC)
2000/01/07 SUPPL 48 Approval Labeling
2000/01/07 SUPPL 47 Approval Manufacturing (CMC)
1998/12/09 SUPPL 46 Approval Manufacturing (CMC)
1996/10/22 SUPPL 43 Approval Manufacturing (CMC)
1996/10/03 SUPPL 45 Approval Manufacturing (CMC)
1996/09/20 SUPPL 40 Approval Manufacturing (CMC)
1995/11/02 SUPPL 41 Approval Manufacturing (CMC)
1994/07/15 SUPPL 39 Approval Manufacturing (CMC)
1994/02/24 SUPPL 38 Approval Manufacturing (CMC)
1993/01/12 SUPPL 37 Approval Labeling
1992/01/31 SUPPL 36 Approval Labeling
1991/07/02 SUPPL 34 Approval Manufacturing (CMC)
1991/07/02 SUPPL 33 Approval Manufacturing (CMC)
1991/06/14 SUPPL 35 Approval Labeling
1990/08/03 SUPPL 32 Approval Manufacturing (CMC)
1989/08/24 SUPPL 30 Approval Labeling
1988/11/29 SUPPL 29 Approval Labeling
1988/03/07 SUPPL 28 Approval Labeling
1987/09/22 SUPPL 27 Approval Labeling
1987/07/20 SUPPL 26 Approval Manufacturing (CMC)
1984/09/10 SUPPL 25 Approval Manufacturing (CMC)
1981/05/19 ORIG 1 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:DOPAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:40MG/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
018132 001 NDA DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 40MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
207707 001 ANDA DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 40MG/ML Prescription No No AP 2018/04/11 HIKMA INTL PHARMS
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:80MG/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
018132 004 NDA DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/ML Prescription Yes Yes AP 1982/07/09 HOSPIRA
207707 002 ANDA DOPAMINE HYDROCHLORIDE DOPAMINE HYDROCHLORIDE INJECTABLE;INJECTION 80MG/ML Prescription No No AP 2018/04/11 HIKMA INTL PHARMS
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