药品注册申请号：019630
申请类型：NDA (新药申请)
申请人：B BRAUN
申请人全名：B BRAUN MEDICAL INC
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 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;37MG/100ML;110MG/100ML No No None 1988/02/17 1988/02/17 Prescription
002 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;110MG/100ML No No None 1988/02/17 Prescription
003 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML;110MG/100ML No No None 1988/02/17 Prescription
004 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;110MG/100ML No No None 1988/02/17 Prescription
005 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;110MG/100ML No No None 1988/02/17 Prescription
006 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;110MG/100ML No No None 1988/02/17 Prescription
007 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;37MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
008 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;200MG/100ML No No AP 1988/02/17 Prescription
009 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
010 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;200MG/100ML No No AP 1988/02/17 Prescription
011 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
012 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;200MG/100ML No No AP 1988/02/17 Prescription
013 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;37MG/100ML;330MG/100ML No No None 1988/02/17 Prescription
014 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 No No AP 1988/02/17 Prescription
015 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML;330MG/100ML No No None 1988/02/17 Prescription
016 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 No No AP 1988/02/17 Prescription
017 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;330MG/100ML No No None 1988/02/17 Prescription
018 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 No No AP 1988/02/17 Prescription
019 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;37MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
020 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;450MG/100ML No No AP 1988/02/17 Prescription
021 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
022 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;450MG/100ML No No AP 1988/02/17 Prescription
023 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
024 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;450MG/100ML No No AP 1988/02/17 Prescription
025 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;37MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
026 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;900MG/100ML No No AP 1988/02/17 Prescription
027 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
028 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;900MG/100ML No No AP 1988/02/17 Prescription
029 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
030 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;900MG/100ML No No AP 1988/02/17 Prescription
031 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;37MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
032 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;75MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
033 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;110MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
034 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;150MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
035 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;220MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
036 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;300MG/100ML;200MG/100ML No No None 1988/02/17 Prescription
037 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;37MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
038 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;75MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
039 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;110MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
040 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;150MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
041 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;220MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
042 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;300MG/100ML;450MG/100ML No No None 1988/02/17 Prescription
043 POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;37MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
044 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;75MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
045 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;110MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
046 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;150MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
047 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;220MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
048 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;300MG/100ML;900MG/100ML No No None 1988/02/17 Prescription
049 POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;75MG/100ML;300MG/100ML No No None 1992/05/07 Prescription
050 POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;110MG/100ML;300MG/100ML No No None 1992/05/07 Prescription
051 POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;150MG/100ML;300MG/100ML No No None 1992/05/07 Prescription
052 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;220MG/100ML;300MG/100ML No No None 1992/05/07 Prescription
053 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;300MG/100ML;300MG/100ML No No None 1992/05/07 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
2023/06/27 SUPPL-53（补充） Approval Labeling STANDARD
2014/08/22 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
2013/05/30 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
2013/05/22 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
2005/08/31 SUPPL-26（补充） Approval Labeling STANDARD
2004/09/27 SUPPL-23（补充） Approval Labeling STANDARD
2002/07/23 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2002/03/08 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2001/03/12 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1999/05/04 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1998/09/25 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1995/01/13 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1994/12/21 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1993/07/21 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1992/12/29 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1992/05/07 SUPPL-9（补充） Approval Labeling
1992/05/07 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1991/08/29 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1990/09/18 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1990/04/13 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1989/11/21 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1989/05/05 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1988/12/21 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1988/08/25 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1988/03/24 SUPPL-1（补充） Approval Labeling
1988/02/17 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;200MG/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
018037 002 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;200MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018037 006 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;200MG/100ML Prescription No No AP 1982/04/13 BAXTER HLTHCARE
019630 008 NDA POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;200MG/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;200MG/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
018037 003 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K) DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;200MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018037 007 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;200MG/100ML Prescription No No AP 1982/04/13 BAXTER HLTHCARE
018037 008 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;200MG/100ML Prescription No No AP 1982/04/13 BAXTER HLTHCARE
019630 010 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;200MG/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;200MG/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
018037 001 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K) DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;200MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018037 009 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;200MG/100ML Prescription No No AP 1982/04/13 BAXTER HLTHCARE
019630 012 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;200MG/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;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;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;75MG/100ML;450MG/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
018008 005 NDA POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;450MG/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
019630 020 NDA POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;450MG/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;450MG/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
018008 006 NDA POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;450MG/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
018008 007 NDA POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;450MG/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
019630 022 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;450MG/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;450MG/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
018008 010 NDA DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;450MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018008 009 NDA POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;450MG/100ML Prescription No No AP 1982/04/28 BAXTER HLTHCARE
019630 024 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;450MG/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;900MG/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
019630 026 NDA POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;900MG/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;900MG/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
019308 005 NDA POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;900MG/100ML Prescription No No AP 1985/04/05 BAXTER HLTHCARE
019630 028 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;900MG/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;900MG/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
019308 007 NDA POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;900MG/100ML Prescription No No AP 1985/04/05 BAXTER HLTHCARE
019630 030 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;900MG/100ML Prescription No No AP 1988/02/17 B BRAUN
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