药品注册申请号:016673
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
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 1971/03/04 Approved Prior to Jan 1, 1982 Prescription
003 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Yes Yes AP 1985/10/30 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
2019/08/05 SUPPL 149 Approval Labeling STANDARD
2016/07/14 SUPPL 152 Approval Manufacturing (CMC) STANDARD
2016/01/15 SUPPL 151 Approval Manufacturing (CMC) STANDARD
2015/09/16 SUPPL 150 Approval Manufacturing (CMC) STANDARD
2014/12/22 SUPPL 147 Approval Labeling STANDARD
2014/05/23 SUPPL 148 Approval Manufacturing (CMC) STANDARD
2006/07/10 SUPPL 140 Approval Labeling
2005/02/04 SUPPL 135 Approval Labeling
2003/05/15 SUPPL 129 Approval Labeling
2001/08/29 SUPPL 127 Approval Manufacturing (CMC) STANDARD
2000/01/28 SUPPL 126 Approval Manufacturing (CMC) STANDARD
1999/09/15 SUPPL 122 Approval Labeling
1997/12/29 SUPPL 125 Approval Manufacturing (CMC) STANDARD
1997/06/10 SUPPL 123 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 124 Approval Manufacturing (CMC) STANDARD
1996/11/14 SUPPL 120 Approval Manufacturing (CMC) STANDARD
1996/10/11 SUPPL 121 Approval Manufacturing (CMC) STANDARD
1995/09/27 SUPPL 119 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 117 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 118 Approval Manufacturing (CMC) STANDARD
1993/06/01 SUPPL 112 Approval Manufacturing (CMC) STANDARD
1993/01/06 SUPPL 116 Approval Manufacturing (CMC) STANDARD
1992/11/23 SUPPL 111 Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL 110 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 107 Approval Manufacturing (CMC) STANDARD
1990/07/30 SUPPL 109 Approval Manufacturing (CMC) STANDARD
1990/03/23 SUPPL 108 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 106 Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL 105 Approval Manufacturing (CMC) STANDARD
1989/01/10 SUPPL 103 Approval Manufacturing (CMC) STANDARD
1988/06/14 SUPPL 104 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 101 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 100 Approval Manufacturing (CMC) STANDARD
1987/04/27 SUPPL 102 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 97 Approval Manufacturing (CMC) STANDARD
1985/10/30 SUPPL 90 Approval Labeling
1985/10/30 SUPPL 89 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 84 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 83 Approval Manufacturing (CMC) STANDARD
1985/06/13 SUPPL 92 Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL 96 Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL 95 Approval Labeling
1985/01/24 SUPPL 81 Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL 67 Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL 91 Approval Manufacturing (CMC) STANDARD
1984/09/21 SUPPL 88 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 82 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 87 Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL 75 Approval Labeling
1982/06/03 SUPPL 72 Approval Manufacturing (CMC) STANDARD
1982/04/16 SUPPL 70 Approval Manufacturing (CMC) STANDARD
1982/04/08 SUPPL 78 Approval Labeling
1982/02/16 SUPPL 76 Approval Manufacturing (CMC) STANDARD
1981/12/21 SUPPL 68 Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL 74 Approval Manufacturing (CMC) STANDARD
1981/11/09 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL 69 Approval Labeling
1981/08/06 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1981/06/29 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1981/05/20 SUPPL 77 Approval Manufacturing (CMC) STANDARD
1981/04/23 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1980/08/06 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1980/05/27 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1980/02/22 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1979/08/02 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1979/03/23 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1978/10/20 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1978/10/12 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1978/09/08 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1978/08/07 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1978/08/02 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1978/06/20 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1978/04/25 SUPPL 43 Approval Labeling
1978/03/24 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1978/03/22 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1978/01/11 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1978/01/11 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1978/01/11 SUPPL 28 Approval Labeling
1978/01/11 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1977/06/06 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1977/02/11 SUPPL 32 Approval Labeling
1977/02/07 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1976/10/12 SUPPL 20 Approval Labeling
1976/07/13 SUPPL 30 Approval Labeling
1976/07/01 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1976/06/17 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1976/05/11 SUPPL 18 Approval Labeling
1976/01/05 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1976/01/02 SUPPL 24 Approval Labeling
1975/09/17 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1975/07/30 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1975/07/10 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1975/06/16 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1971/03/04 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
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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