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
2021/04/13 SUPPL-42(补充) Approval Labeling STANDARD
2018/10/12 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2016/09/27 SUPPL-27(补充) Approval Labeling STANDARD
2015/09/01 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
2015/02/09 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
2014/09/30 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
2014/09/15 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2014/08/29 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2009/11/02 SUPPL-21(补充) Approval Labeling STANDARD
2004/01/23 SUPPL-14(补充) Approval Labeling STANDARD
2003/05/21 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2002/07/25 SUPPL-11(补充) Approval Labeling STANDARD
2002/07/25 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2002/02/15 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2001/04/04 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2000/10/19 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2000/04/12 SUPPL-3(补充) Approval Efficacy STANDARD
2000/03/24 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2000/02/25 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1999/05/25 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1999/04/15 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1997/03/26 ORIG-1(原始申请) Approval Type 4 - New Combination STANDARD
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