药品注册申请号:018561
申请类型:NDA (新药申请)
申请人:ICU MEDICAL INC
申请人全名:ICU 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 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML Yes Yes AP 1982/03/23 1982/03/23 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
2018/05/14 SUPPL 60 Approval Labeling STANDARD
2016/02/22 SUPPL 57 Approval Labeling STANDARD
2003/09/11 SUPPL 43 Approval Labeling
2002/11/01 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1999/07/16 SUPPL 40 Approval Labeling
1999/05/27 SUPPL 38 Approval Labeling
1998/12/01 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL 35 Approval Labeling
1997/06/11 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1997/03/28 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1993/12/13 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1993/01/21 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1989/02/06 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1986/06/25 SUPPL 5 Approval Labeling
1986/06/25 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1985/03/11 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1984/09/08 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1984/01/17 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1982/03/23 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: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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