药品注册申请号:016730
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 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Yes Yes AP 1973/12/21 Approved Prior to Jan 1, 1982 Prescription
002 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 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
2014/09/29 SUPPL 52 Approval Manufacturing (CMC) STANDARD
2006/10/19 SUPPL 50 Approval Labeling
2004/08/06 SUPPL 48 Approval Labeling
1997/06/23 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1995/08/08 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1991/12/31 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1990/09/11 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1989/03/09 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1986/02/18 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1986/01/30 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1985/09/16 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1985/06/24 SUPPL 36 Approval Labeling
1985/06/21 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1985/05/17 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1985/04/03 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1984/10/16 SUPPL 34 Approval Labeling
1984/04/09 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1983/09/30 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1983/01/24 SUPPL 20 Approval Labeling
1982/11/05 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1982/06/28 SUPPL 23 Approval Labeling
1982/06/28 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1981/10/26 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1981/09/30 SUPPL 19 Approval Labeling
1981/09/30 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1980/10/24 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1980/08/06 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1980/07/16 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1980/02/12 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1979/10/16 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1979/10/09 SUPPL 13 Approval Labeling
1979/06/08 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1979/03/14 SUPPL 10 Approval Labeling
1979/03/12 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1978/11/02 SUPPL 6 Approval Labeling
1978/11/02 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1978/10/12 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1978/04/28 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1977/10/21 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1977/08/19 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1977/05/25 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1976/12/06 SUPPL 1 Approval Labeling
1973/12/21 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:50MG/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
016367 002 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
016730 002 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 B BRAUN
016673 003 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Prescription Yes Yes AP 1985/10/30 BAXTER HLTHCARE
020179 002 NDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Prescription Yes Yes AP 1992/12/07 BAXTER HLTHCARE
207449 001 ANDA DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Prescription No No AP 2016/10/21 FRESENIUS KABI USA
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