药品注册申请号：018629
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 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML No No AP 1982/03/23 1982/03/23 Prescription
002 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML No No AP 1982/03/23 Prescription
003 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;330MG/100ML No No AP 1982/03/23 Prescription
004 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML No No AP 1982/03/23 Prescription
005 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML No No AP 1982/03/23 Prescription
006 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML No No AP 1982/03/23 Prescription
007 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;330MG/100ML No No AP 1982/03/23 Prescription
008 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML No No AP 1982/03/23 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
2019/02/21 SUPPL-46（补充） Approval Labeling STANDARD
2018/07/11 SUPPL-48（补充） Approval STANDARD
2006/07/10 SUPPL-39（补充） Approval Labeling
2004/03/15 SUPPL-34（补充） Approval Labeling
2001/08/29 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2001/02/28 SUPPL-30（补充） Approval Labeling
2000/01/28 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1991/12/11 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1985/07/03 SUPPL-13（补充） Approval Labeling
1985/06/13 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1984/10/23 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1983/07/11 SUPPL-9（补充） Approval Labeling
1982/05/25 SUPPL-2（补充） Approval Labeling
1982/05/07 SUPPL-1（补充） Approval Labeling
1982/03/23 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
无
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
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;75MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 001 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 005 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
019630 014 NDA POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML Prescription No No AP 1988/02/17 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;150MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 002 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 004 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
019630 016 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML Prescription No No AP 1988/02/17 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;224MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 003 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 007 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;150MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 002 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 004 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
019630 016 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML Prescription No No AP 1988/02/17 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;75MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 001 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 005 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
019630 014 NDA POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML Prescription No No AP 1988/02/17 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;300MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 006 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 008 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
019630 018 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML Prescription No No AP 1988/02/17 B BRAUN
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;224MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 003 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 007 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
活性成分:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/100ML;300MG/100ML;330MG/100ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018629 006 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
018629 008 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML Prescription No No AP 1982/03/23 BAXTER HLTHCARE
019630 018 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML Prescription No No AP 1988/02/17 B BRAUN
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