药品注册申请号:017634
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% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Yes No AP 1979/02/01 Approved Prior to Jan 1, 1982 Prescription
002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Yes No AP Approved Prior to Jan 1, 1982 Prescription
003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML Yes No AP Approved Prior to Jan 1, 1982 Prescription
004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML Yes No None 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
2019/07/15 SUPPL 76 Approval Labeling STANDARD
2017/05/26 SUPPL 73 Approval Labeling STANDARD
2017/05/26 SUPPL 71 Approval Labeling STANDARD
2014/12/22 SUPPL 69 Approval Labeling STANDARD
2014/09/25 SUPPL 70 Approval Manufacturing (CMC) STANDARD
2005/08/26 SUPPL 65 Approval Manufacturing (CMC) STANDARD
2005/05/23 SUPPL 64 Approval Labeling STANDARD
2003/01/03 SUPPL 59 Approval Labeling STANDARD
2001/08/14 SUPPL 60 Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1992/02/14 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1985/06/26 SUPPL 41 Approval Labeling
1985/06/13 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1984/10/23 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL 27 Approval Labeling
1983/03/01 SUPPL 14 Approval Labeling
1983/03/01 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1982/06/03 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1982/05/25 SUPPL 30 Approval Labeling
1982/04/16 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1982/04/12 SUPPL 29 Approval Labeling
1981/12/21 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1981/11/09 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL 21 Approval Labeling
1981/06/29 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1981/05/29 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1980/07/22 SUPPL 12 Approval Labeling
1980/06/28 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1980/05/28 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1980/05/28 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1979/08/02 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1979/02/01 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; POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;150MG/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
017634 001 NDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019699 004 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Prescription No No AP 1989/09/29 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;300MG/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
017634 002 NDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019699 006 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Prescription No No AP 1989/09/29 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;224MG/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
017634 003 NDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
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