药品注册申请号:019626
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 DEXTROSE 2.5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 2.5GM/100ML No No None 1988/02/02 1988/02/02 Discontinued
002 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Yes Yes AP 1988/02/02 Prescription
003 DEXTROSE 7.7% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 7.7GM/100ML No No None 1988/02/02 Discontinued
004 DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Yes Yes AP 1988/02/02 Prescription
005 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Yes Yes AP 2015/02/18 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
2015/11/20 SUPPL 31 Approval Manufacturing (CMC) STANDARD
2015/02/18 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2014/08/22 SUPPL 27 Approval Manufacturing (CMC) STANDARD
2004/02/13 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2002/07/23 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2002/03/08 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2001/03/12 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2000/04/11 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/09/25 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1993/07/21 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1993/06/01 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1993/04/26 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1991/08/29 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1990/09/18 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1990/04/13 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1989/11/21 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1989/05/05 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1988/12/21 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1988/03/16 SUPPL 1 Approval Labeling
1988/02/02 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:DEXTROSE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/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
016673 001 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
016730 001 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 B BRAUN
019466 001 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Prescription Yes Yes AP 1985/07/15 HOSPIRA
019479 001 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Prescription Yes Yes AP 1985/09/17 HOSPIRA
019626 002 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Prescription Yes Yes AP 1988/02/02 B BRAUN
020179 001 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Prescription Yes Yes AP 1992/12/07 BAXTER HLTHCARE
活性成分:DEXTROSE 剂型/给药途径:INJECTABLE;INJECTION 规格:10GM/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
016694 001 NDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018080 001 NDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
019626 004 NDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription Yes Yes AP 1988/02/02 B BRAUN
209448 001 ANDA DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Prescription No No AP 2018/07/16 FRESENIUS KABI USA
活性成分:DEXTROSE 剂型/给药途径:INJECTABLE;INJECTION 规格:70GM/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
018561 001 NDA DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Prescription Yes Yes AP 1982/03/23 ICU MEDICAL INC
019893 001 NDA DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Prescription Yes Yes AP 1989/12/26 ICU MEDICAL INC
020047 003 NDA DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Prescription Yes Yes AP 1991/07/02 BAXTER HLTHCARE
019626 005 NDA DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Prescription Yes Yes AP 2015/02/18 B BRAUN
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