药品注册申请号:020147
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 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;5GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML No No None 1995/10/23 1995/10/23 Discontinued
002 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;10GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML No No None 1995/10/23 Discontinued
003 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;15GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML No No None 1995/10/23 Discontinued
004 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;20GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML No No None 1995/10/23 Discontinued
005 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;25GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML No No None 1995/10/23 Discontinued
006 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML No No None 1995/10/23 Discontinued
007 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML No No None 1995/10/23 Discontinued
008 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;15GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML No No None 1995/10/23 Discontinued
009 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML No No None 1995/10/23 Discontinued
010 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML No No None 1995/10/23 Discontinued
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
2001/08/14 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2000/04/12 SUPPL 6 Approval Efficacy STANDARD
2000/03/24 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1999/03/31 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1997/11/06 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1997/10/09 SUPPL 2 Approval Labeling STANDARD
1997/04/29 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1995/10/23 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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database