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
与本品相关的专利信息（来自FDA橙皮书Orange Book）
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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
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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
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