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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2001/08/14 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2000/04/12 SUPPL-6(补充) Approval Efficacy STANDARD
2000/03/24 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1999/03/31 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1997/11/06 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1997/10/09 SUPPL-2(补充) Approval Labeling STANDARD
1997/04/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1995/10/23 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD
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与本品治疗等效的药品
本品无治疗等效药品
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