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
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
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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
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
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