药品注册申请号:020201
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 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/100ML Yes Yes AP 1993/09/27 1993/10/19 Prescription
002 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/100ML Yes Yes AP 1993/10/19 Prescription
003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/100ML Yes Yes AP 1993/10/19 Prescription
006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MG BASE/100ML Yes Yes AP 1994/07/07 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
2019/05/24 SUPPL 40 Approval Labeling STANDARD
2016/05/31 SUPPL 36 Approval Labeling STANDARD
2002/12/02 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2002/11/05 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2002/04/03 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2002/04/03 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2001/04/10 SUPPL 13 Approval Labeling STANDARD
1999/09/01 SUPPL 12 Approval Labeling STANDARD
1999/02/17 SUPPL 9 Approval Labeling STANDARD
1998/10/28 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1997/08/21 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1996/06/26 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1995/08/17 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1995/08/03 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1994/07/07 SUPPL 4 Approval Labeling STANDARD
1994/07/07 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1994/05/19 SUPPL 2 Approval Labeling STANDARD
1994/02/24 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1993/09/27 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:DOBUTAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MG BASE/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
020201 001 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/100ML Prescription Yes Yes AP 1993/10/19 HOSPIRA
020255 004 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/100ML Prescription Yes Yes AP 1993/10/19 BAXTER HLTHCARE
活性成分:DOBUTAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 100MG BASE/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
020201 002 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/100ML Prescription Yes Yes AP 1993/10/19 HOSPIRA
020255 003 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 100MG BASE/100ML Prescription Yes Yes AP 1993/10/19 BAXTER HLTHCARE
活性成分:DOBUTAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/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
020201 003 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/100ML Prescription Yes Yes AP 1993/10/19 HOSPIRA
020255 001 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/100ML Prescription Yes Yes AP 1993/10/19 BAXTER HLTHCARE
活性成分:DOBUTAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 400MG BASE/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
020255 005 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MG BASE/100ML Prescription Yes Yes AP 1993/10/19 BAXTER HLTHCARE
020201 006 NDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MG BASE/100ML Prescription Yes Yes AP 1994/07/07 HOSPIRA
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