药品注册申请号:020179
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
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 1992/12/07 1992/12/07 Prescription
002 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Yes Yes AP 1992/12/07 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
2019/08/05 SUPPL 56 Approval Labeling STANDARD
2019/08/05 SUPPL 12 Approval Labeling STANDARD
2003/11/20 SUPPL 7 Approval Labeling
2001/05/04 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/09/15 SUPPL 3 Approval Labeling
1997/12/29 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1992/12/07 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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