药品注册申请号:017608
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 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Yes No AP 1975/08/13 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
2015/12/24 SUPPL 140 Approval Manufacturing (CMC) STANDARD
2014/09/08 SUPPL 137 Approval Manufacturing (CMC) STANDARD
2014/08/15 SUPPL 139 Approval Manufacturing (CMC) STANDARD
1999/10/28 SUPPL 116 Approval Labeling
1999/10/12 SUPPL 113 Approval Labeling
1998/12/01 SUPPL 115 Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL 114 Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL 109 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 108 Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL 112 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 111 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 110 Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL 104 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 103 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 105 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 100 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 101 Approval Manufacturing (CMC) STANDARD
1988/08/31 SUPPL 73 Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL 97 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 96 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 95 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 93 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 88 Approval Manufacturing (CMC) STANDARD
1985/12/06 SUPPL 94 Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL 77 Approval Labeling
1985/11/29 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL 75 Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL 86 Approval Labeling
1985/10/26 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1985/09/30 SUPPL 89 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1985/08/27 SUPPL 87 Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL 90 Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL 85 Approval Manufacturing (CMC) STANDARD
1985/03/15 SUPPL 68 Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1984/11/09 SUPPL 83 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 80 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 70 Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL 65 Approval Labeling
1984/10/10 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1983/10/25 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1982/07/21 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1982/06/18 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1982/06/17 SUPPL 51 Approval Labeling
1982/06/09 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1981/08/28 SUPPL 53 Approval Labeling
1981/03/02 SUPPL 50 Approval Labeling
1981/03/02 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1981/02/18 SUPPL 52 Approval Labeling
1981/01/07 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1980/06/10 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1980/05/02 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1980/05/02 SUPPL 39 Approval Labeling
1980/04/08 SUPPL 43 Approval Labeling
1980/02/12 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1980/02/06 SUPPL 33 Approval Labeling
1980/01/22 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1979/11/29 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1979/11/27 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1979/10/29 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1979/10/10 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1979/02/06 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1979/02/01 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1979/01/05 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1978/12/29 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1978/11/22 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1978/11/22 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1978/11/08 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1978/10/11 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1978/08/15 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1978/08/02 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1978/06/26 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1978/06/14 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1978/06/14 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1978/03/30 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1978/03/15 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1978/02/13 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1978/02/08 SUPPL 20 Approval Labeling
1978/01/23 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1977/11/22 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1977/09/28 SUPPL 13 Approval Labeling
1977/05/20 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1977/04/29 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1977/01/27 SUPPL 8 Approval Labeling
1976/11/08 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1976/06/28 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1975/11/20 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1975/11/03 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1975/10/17 SUPPL 4 Approval Labeling
1975/10/15 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1975/08/13 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:CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/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
016679 001 NDA LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017608 001 NDA DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
019634 003 NDA DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Prescription No No AP 1988/02/24 B BRAUN
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