药品注册申请号:019466
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 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 5GM/100ML Yes Yes AP 1985/07/15 1985/07/15 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
2019/05/29 SUPPL 62 Approval Manufacturing (CMC) N/A
2016/06/10 SUPPL 57 Approval Labeling STANDARD
2002/11/01 SUPPL 40 Approval Manufacturing (CMC) STANDARD
2000/04/06 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2000/04/06 SUPPL 38 Approval Labeling
2000/04/06 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1999/03/31 SUPPL 36 Approval Labeling
1998/12/01 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL 32 Approval Labeling
1997/06/11 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1996/01/24 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1995/05/31 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1995/01/05 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1994/09/23 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1994/02/25 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1993/02/16 SUPPL 16 Approval Labeling
1992/01/28 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1991/12/30 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1990/11/02 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1990/03/09 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1989/09/20 SUPPL 9 Approval Labeling
1989/08/03 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1989/07/18 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1989/02/06 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1986/08/11 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1986/05/27 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1986/01/17 SUPPL 1 Approval Labeling
1985/07/15 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
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药品NDC数据与药品包装、标签说明书
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