药品注册申请号:018080
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 10% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 10GM/100ML Yes Yes AP 1979/08/28 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
2014/09/08 SUPPL 115 Approval Manufacturing (CMC) STANDARD
2008/08/07 SUPPL 99 Approval Labeling
2003/04/24 SUPPL 84 Approval Labeling
2002/11/01 SUPPL 82 Approval Manufacturing (CMC) STANDARD
2002/07/24 SUPPL 81 Approval Labeling
1999/03/31 SUPPL 80 Approval Labeling
1998/12/01 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL 77 Approval Labeling
1997/06/11 SUPPL 78 Approval Manufacturing (CMC) STANDARD
1997/03/28 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL 75 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 73 Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1993/10/25 SUPPL 61 Approval Labeling
1993/10/25 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1989/02/06 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1986/06/25 SUPPL 31 Approval Labeling
1986/06/25 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL 40 Approval Labeling
1985/11/29 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL 50 Approval Labeling
1985/10/26 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1985/03/11 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL 27 Approval Labeling
1984/10/10 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1984/09/08 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1984/02/24 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 16 Approval Labeling
1982/06/09 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1981/10/05 SUPPL 15 Approval Labeling
1981/10/05 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1981/07/08 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1981/03/02 SUPPL 17 Approval Labeling
1981/03/02 SUPPL 13 Approval Labeling
1981/03/02 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1980/09/11 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1980/07/11 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1980/05/23 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1980/05/05 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1980/04/08 SUPPL 4 Approval Labeling
1979/12/07 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL 2 Approval Labeling
1979/10/10 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1979/08/28 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: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
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