药品注册申请号:017648
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 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Yes No AP 1979/02/02 Approved Prior to Jan 1, 1982 Prescription
002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 300MG/100ML;900MG/100ML Yes No AP Approved Prior to Jan 1, 1982 Prescription
003 POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 224MG/100ML;900MG/100ML Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 75MG/100ML;900MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;450MG/100ML Yes Yes AP 2002/11/26 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
2019/01/11 SUPPL 71 Approval Labeling STANDARD
2016/11/17 SUPPL 70 Approval Manufacturing (CMC) STANDARD
2015/01/12 SUPPL 69 Approval Manufacturing (CMC) STANDARD
2005/08/26 SUPPL 65 Approval Manufacturing (CMC) STANDARD
2005/05/23 SUPPL 64 Approval Labeling STANDARD
2003/01/10 SUPPL 58 Approval Labeling STANDARD
2002/11/26 SUPPL 61 Approval Manufacturing (CMC) STANDARD
2001/08/14 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1991/12/11 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL 51 Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 43 Approval Manufacturing (CMC) STANDARD
1985/10/04 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1985/06/26 SUPPL 40 Approval Labeling
1985/06/13 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1982/06/03 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1982/05/25 SUPPL 31 Approval Labeling
1982/04/16 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1982/04/12 SUPPL 30 Approval Labeling
1981/12/21 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1981/11/09 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL 22 Approval Labeling
1981/06/29 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1981/05/29 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL 3 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
1980/02/25 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1980/02/22 SUPPL 12 Approval Labeling
1979/08/02 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1979/06/14 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1979/02/02 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:POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:150MG/100ML;900MG/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
017648 001 NDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019708 004 NDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Prescription No No AP 1989/09/29 B BRAUN
活性成分:POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:300MG/100ML;900MG/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
017648 002 NDA POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 300MG/100ML;900MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
活性成分:POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:150MG/100ML;450MG/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
017648 005 NDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;450MG/100ML Prescription Yes Yes AP 2002/11/26 BAXTER HLTHCARE
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