药品注册申请号：017634
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% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Yes No AP 1979/02/01 Approved Prior to Jan 1, 1982 Prescription
002 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Yes No AP Approved Prior to Jan 1, 1982 Prescription
003 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;224MG/100ML Yes No None Approved Prior to Jan 1, 1982 Prescription
004 DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML Yes No AP Approved Prior to Jan 1, 1982 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1979/02/01 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/07/15 SUPPL-76（补充） Approval Labeling-Package Insert STANDARD
2017/05/26 SUPPL-73（补充） Approval Labeling-Package Insert STANDARD
2017/05/26 SUPPL-71（补充） Approval Labeling-Package Insert STANDARD
2014/12/22 SUPPL-69（补充） Approval Labeling-Package Insert STANDARD
2014/09/25 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
2005/08/26 SUPPL-65（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2005/05/23 SUPPL-64（补充） Approval Labeling STANDARD
2003/01/03 SUPPL-59（补充） Approval Labeling STANDARD
2001/08/14 SUPPL-60（补充） Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL-58（补充） Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL-57（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/09/30 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/02/18 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/02/14 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/04/29 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/03/26 SUPPL-51（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/02/15 SUPPL-50（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/26 SUPPL-49（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/01/12 SUPPL-48（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/07/25 SUPPL-47（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/05/28 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/02/27 SUPPL-43（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/08/28 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/08/28 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/06/26 SUPPL-41（补充） Approval Labeling
1985/06/13 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/04/15 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/01/24 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/23 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/16 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/28 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/07/11 SUPPL-27（补充） Approval Labeling
1983/03/01 SUPPL-14（补充） Approval Labeling
1983/03/01 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/06/03 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/05/25 SUPPL-30（补充） Approval Labeling
1982/04/16 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/04/12 SUPPL-29（补充） Approval Labeling
1981/12/21 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/20 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/09 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/08/26 SUPPL-21（补充） Approval Labeling
1981/06/29 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/05/29 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/04/16 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/21 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/08/07 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/07/22 SUPPL-12（补充） Approval Labeling
1980/06/28 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/18 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/30 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/28 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/28 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/02/25 SUPPL-1（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/08/02 SUPPL-4（补充） Approval Manufacturing (CMC)-Control 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; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;150MG/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
017634 001 NDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019699 004 NDA POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Prescription No No AP 1989/09/29 B BRAUN
212346 002 ANDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML Prescription No No AP 2020/09/10 FRESENIUS KABI USA
>>>活性成分:DEXTROSE; POTASSIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;300MG/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
017634 002 NDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019699 006 NDA POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML Prescription No No AP 1989/09/29 B BRAUN
>>>活性成分:DEXTROSE; POTASSIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;75MG/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
017634 004 NDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
212346 001 ANDA DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% DEXTROSE; POTASSIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML Prescription No No AP 2020/09/10 FRESENIUS KABI USA
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药品NDC数据与药品包装、标签说明书
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