药品注册申请号:020678
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 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML Yes Yes None 1997/03/26 1997/03/26 Prescription
002 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML Yes Yes None 1997/03/26 Prescription
005 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML Yes Yes None 1997/03/26 Prescription
008 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML Yes Yes None 1997/03/26 Prescription
009 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML Yes Yes None 1997/03/26 Prescription
011 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML Yes Yes None 1997/03/26 Prescription
012 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML Yes Yes None 1997/03/26 Prescription
016 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML Yes Yes None 1997/03/26 Prescription
017 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML Yes Yes None 1997/03/26 Prescription
018 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML Yes Yes None 1997/03/26 Prescription
019 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML Yes Yes None 1997/03/26 Prescription
021 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML Yes Yes None 1997/03/26 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
2018/10/12 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2016/09/27 SUPPL 27 Approval Labeling STANDARD
2015/09/01 SUPPL 31 Approval Manufacturing (CMC) STANDARD
2015/02/09 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2014/09/30 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2014/09/15 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2014/08/29 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2009/11/02 SUPPL 21 Approval Labeling STANDARD
2004/01/23 SUPPL 14 Approval Labeling STANDARD
2003/05/21 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2002/07/25 SUPPL 11 Approval Labeling STANDARD
2002/07/25 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2002/02/15 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2001/04/04 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2000/10/19 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2000/04/12 SUPPL 3 Approval Efficacy STANDARD
2000/03/24 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2000/02/25 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1999/05/25 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1999/04/15 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/03/26 ORIG 1 Approval Type 4 - New Combination STANDARD
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