药品注册申请号:020734
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 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;5GM/100ML No No None 1997/09/29 1997/09/29 Prescription
002 CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;10GM/100ML No No None 1997/09/29 Prescription
005 CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;25GM/100ML No No None 1997/09/29 Prescription
007 CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;5GM/100ML No No None 1997/09/29 Prescription
008 CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;10GM/100ML No No None 1997/09/29 Prescription
010 CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;20GM/100ML No No None 1997/09/29 Prescription
011 CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;25GM/100ML No No None 1997/09/29 Prescription
014 CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;10GM/100ML No No None 1997/09/29 Prescription
015 CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;15GM/100ML No No None 1997/09/29 Prescription
016 CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;20GM/100ML No No None 1997/09/29 Prescription
017 CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;25GM/100ML No No None 1997/09/29 Prescription
018 CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 5%;35GM/100ML No No None 1997/09/29 Prescription
019 CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 8%;14GM/100ML No No None 2021/04/13 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-37(补充) Approval Labeling STANDARD
2018/10/12 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2016/09/27 SUPPL-25(补充) Approval Labeling STANDARD
2016/01/19 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2014/09/15 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
2014/08/29 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
2009/11/02 SUPPL-19(补充) Approval Labeling STANDARD
2004/01/23 SUPPL-13(补充) Approval Labeling STANDARD
2003/05/21 SUPPL-12(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
1997/09/29 ORIG-1(原始申请) Approval Type 4 - New Combination STANDARD
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本品无治疗等效药品
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