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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1995/10/23 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；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-Labeling Change With Clinical Data STANDARD
2000/03/24 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/11/24 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1999/03/31 SUPPL-4（补充） Approval Manufacturing (CMC)-Control 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)-Packaging 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
无
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
无
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
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database