药品注册申请号：017648
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 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Yes Yes AP 1979/02/02 Approved Prior to Jan 1, 1982 Prescription
002 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 300MG/100ML;900MG/100ML Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
003 POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 224MG/100ML;900MG/100ML Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 75MG/100ML;900MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;450MG/100ML Yes Yes AP 2002/11/26 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
2019/01/11 SUPPL-71（补充） Approval Labeling STANDARD
2016/11/17 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
2015/01/12 SUPPL-69（补充） Approval Manufacturing (CMC) STANDARD
2005/08/26 SUPPL-65（补充） Approval Manufacturing (CMC) STANDARD
2005/05/23 SUPPL-64（补充） Approval Labeling STANDARD
2003/01/10 SUPPL-58（补充） Approval Labeling STANDARD
2002/11/26 SUPPL-61（补充） Approval Manufacturing (CMC) STANDARD
2001/08/14 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL-57（补充） Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL-56（补充） Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
1991/12/11 SUPPL-53（补充） Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL-51（补充） Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL-49（补充） Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
1989/01/12 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL-46（补充） Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1985/10/04 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
1985/06/26 SUPPL-40（补充） Approval Labeling
1985/06/13 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
1982/06/03 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1982/05/25 SUPPL-31（补充） Approval Labeling
1982/04/16 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1982/04/12 SUPPL-30（补充） Approval Labeling
1981/12/21 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1981/11/20 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1981/11/09 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1981/08/26 SUPPL-22（补充） Approval Labeling
1981/06/29 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1981/05/29 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1981/04/16 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1981/01/21 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1980/08/07 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1980/07/31 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1980/06/28 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1980/06/18 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1980/05/30 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1980/05/28 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1980/02/25 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1980/02/22 SUPPL-12（补充） Approval Labeling
1979/08/02 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1979/06/14 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1979/02/02 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
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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
活性成分:POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格: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
017648 001 NDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019708 004 NDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Prescription No No AP 1989/09/29 B BRAUN
212347 003 ANDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;900MG/100ML Prescription No No AP 2021/06/02 FRESENIUS KABI USA
活性成分:POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格: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
017648 002 NDA POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 300MG/100ML;900MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
212347 002 ANDA POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 300MG/100ML;900MG/100ML Prescription No No AP 2020/09/17 FRESENIUS KABI USA
活性成分:POTASSIUM CHLORIDE; SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格: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
017648 005 NDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;450MG/100ML Prescription Yes Yes AP 2002/11/26 BAXTER HLTHCARE
212347 001 ANDA POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 150MG/100ML;450MG/100ML Prescription No No AP 2020/09/17 FRESENIUS KABI USA
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