药品注册申请号:016367
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
002 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Yes Yes AP 1971/02/12 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
2016/02/23 SUPPL 220 Approval Manufacturing (CMC) STANDARD
2013/09/05 SUPPL 218 Approval Manufacturing (CMC) STANDARD
2006/10/26 SUPPL 182 Approval Manufacturing (CMC) N/A
2005/09/02 SUPPL 178 Approval Manufacturing (CMC) STANDARD
2002/11/08 SUPPL 174 Approval Manufacturing (CMC) STANDARD
2002/04/03 SUPPL 173 Approval Manufacturing (CMC) STANDARD
2002/04/03 SUPPL 172 Approval Manufacturing (CMC) STANDARD
2000/03/06 SUPPL 170 Approval Labeling STANDARD
2000/03/03 SUPPL 171 Approval Manufacturing (CMC) STANDARD
1999/06/04 SUPPL 169 Approval Manufacturing (CMC) STANDARD
1998/10/29 SUPPL 168 Approval Manufacturing (CMC) STANDARD
1997/08/21 SUPPL 167 Approval Manufacturing (CMC) STANDARD
1997/08/20 SUPPL 165 Approval Labeling STANDARD
1997/06/11 SUPPL 166 Approval Manufacturing (CMC) STANDARD
1997/03/28 SUPPL 164 Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL 160 Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL 159 Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL 163 Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL 162 Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL 161 Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL 157 Approval Manufacturing (CMC) STANDARD
1994/05/24 SUPPL 156 Approval Labeling STANDARD
1992/01/28 SUPPL 152 Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL 151 Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL 153 Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL 148 Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL 149 Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL 147 Approval Manufacturing (CMC) STANDARD
1988/10/17 SUPPL 145 Approval Manufacturing (CMC) STANDARD
1988/08/31 SUPPL 107 Approval Manufacturing (CMC) STANDARD
1988/08/08 SUPPL 146 Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL 142 Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL 141 Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL 140 Approval Manufacturing (CMC) STANDARD
1986/02/21 SUPPL 139 Approval Manufacturing (CMC) STANDARD
1986/01/18 SUPPL 138 Approval Manufacturing (CMC) STANDARD
1985/11/29 SUPPL 111 Approval Labeling
1985/11/29 SUPPL 110 Approval Manufacturing (CMC) STANDARD
1985/11/07 SUPPL 133 Approval Labeling
1985/10/29 SUPPL 109 Approval Manufacturing (CMC) STANDARD
1985/10/26 SUPPL 125 Approval Labeling
1985/10/26 SUPPL 121 Approval Manufacturing (CMC) STANDARD
1985/09/30 SUPPL 132 Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL 115 Approval Manufacturing (CMC) STANDARD
1985/08/27 SUPPL 130 Approval Manufacturing (CMC) STANDARD
1985/06/21 SUPPL 135 Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL 134 Approval Manufacturing (CMC) STANDARD
1985/05/03 SUPPL 122 Approval Manufacturing (CMC) STANDARD
1985/01/18 SUPPL 120 Approval Labeling
1985/01/18 SUPPL 119 Approval Manufacturing (CMC) STANDARD
1985/01/08 SUPPL 106 Approval Labeling
1985/01/08 SUPPL 105 Approval Manufacturing (CMC) STANDARD
1984/11/28 SUPPL 108 Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL 116 Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL 101 Approval Manufacturing (CMC) STANDARD
1984/10/10 SUPPL 92 Approval Labeling
1984/10/10 SUPPL 91 Approval Manufacturing (CMC) STANDARD
1984/09/25 SUPPL 102 Approval Manufacturing (CMC) STANDARD
1984/06/14 SUPPL 103 Approval Manufacturing (CMC) STANDARD
1984/04/09 SUPPL 104 Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL 100 Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL 89 Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL 95 Approval Manufacturing (CMC) STANDARD
1983/12/08 SUPPL 97 Approval Manufacturing (CMC) STANDARD
1983/09/19 SUPPL 96 Approval Manufacturing (CMC) STANDARD
1983/08/31 SUPPL 99 Approval Manufacturing (CMC) STANDARD
1983/06/06 SUPPL 94 Approval Manufacturing (CMC) STANDARD
1983/02/15 SUPPL 88 Approval Manufacturing (CMC) STANDARD
1983/01/25 SUPPL 93 Approval Manufacturing (CMC) STANDARD
1983/01/17 SUPPL 98 Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL 90 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 87 Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL 75 Approval Labeling
1982/06/09 SUPPL 83 Approval Manufacturing (CMC) STANDARD
1982/02/22 SUPPL 86 Approval Labeling
1982/02/01 SUPPL 85 Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1981/10/21 SUPPL 81 Approval Labeling
1981/10/21 SUPPL 80 Approval Manufacturing (CMC) STANDARD
1981/10/07 SUPPL 82 Approval Manufacturing (CMC) STANDARD
1981/09/16 SUPPL 79 Approval Manufacturing (CMC) STANDARD
1981/07/31 SUPPL 78 Approval Labeling
1981/07/31 SUPPL 77 Approval Manufacturing (CMC) STANDARD
1981/07/16 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1981/03/02 SUPPL 76 Approval Labeling
1981/03/02 SUPPL 74 Approval Labeling
1981/03/02 SUPPL 73 Approval Manufacturing (CMC) STANDARD
1981/01/07 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1980/07/14 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1980/04/16 SUPPL 63 Approval Labeling
1980/04/16 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1980/04/08 SUPPL 68 Approval Labeling
1980/01/22 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1979/12/03 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1979/11/29 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1979/11/27 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1979/10/10 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1979/07/17 SUPPL 58 Approval Labeling
1979/03/27 SUPPL 51 Approval Labeling
1979/03/27 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1979/03/27 SUPPL 47 Approval Labeling
1979/03/27 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1979/02/16 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1979/02/06 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1979/02/01 SUPPL 57 Approval Supplement STANDARD
1978/11/24 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1978/11/01 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1978/10/17 SUPPL 55 Approval Labeling
1978/09/13 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1978/09/08 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1978/09/08 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1978/09/08 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1978/08/15 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1978/08/03 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1978/07/11 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1978/06/26 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1978/06/05 SUPPL 38 Approval Labeling
1978/06/05 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1978/06/05 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1978/05/31 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1978/04/06 SUPPL 35 Approval Labeling
1978/03/15 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1978/02/17 SUPPL 32 Approval Labeling
1978/02/13 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1978/02/09 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1978/02/08 SUPPL 39 Approval Labeling
1978/01/23 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1978/01/17 SUPPL 53 Approval Labeling
1978/01/17 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1977/09/28 SUPPL 27 Approval Labeling
1977/09/28 SUPPL 26 Approval Labeling
1977/09/09 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1977/09/09 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1977/09/09 SUPPL 21 Approval Labeling
1977/09/09 SUPPL 20 Approval Labeling
1977/04/29 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1976/11/23 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1976/11/08 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1976/10/15 SUPPL 16 Approval Labeling
1976/04/06 SUPPL 10 Approval Labeling
1976/04/06 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1976/03/01 SUPPL 13 Approval Labeling
1975/11/20 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1975/10/29 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1975/09/03 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1975/05/20 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1975/05/20 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1971/02/12 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: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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