药品注册申请号：019904
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 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 14.9MG/ML Yes Yes AP 1989/12/26 1989/12/26 Prescription
002 POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 29.8MG/ML Yes Yes AP 1989/12/26 Prescription
003 POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.24GM/100ML Yes Yes None 1989/12/26 Prescription
004 POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.98GM/100ML Yes Yes AP 1989/12/26 Prescription
005 POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 746MG/100ML Yes Yes AP 1990/12/17 Prescription
006 POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 1.49GM/100ML Yes Yes AP 1990/12/17 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
2024/06/13 SUPPL-25（补充） Approval Labeling STANDARD
2022/06/13 SUPPL-21（补充） Approval Labeling STANDARD
2019/06/20 SUPPL-20（补充） Approval Labeling STANDARD
2017/01/07 SUPPL-14（补充） Approval Labeling STANDARD
2015/02/03 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2012/03/14 SUPPL-12（补充） Approval Labeling STANDARD
2001/01/12 SUPPL-5（补充） Approval Labeling
1997/12/31 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1996/11/06 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1994/06/01 SUPPL-8（补充） Approval Labeling STANDARD
1994/02/18 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1991/04/29 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1990/12/17 SUPPL-3（补充） Approval Labeling
1990/12/17 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1989/12/26 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:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:14.9MG/ML 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
019904 001 NDA POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 14.9MG/ML Prescription Yes Yes AP 1989/12/26 BAXTER HLTHCARE
020161 005 NDA POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 14.9MG/ML Prescription Yes Yes AP 1992/11/30 ICU MEDICAL INC
211087 001 ANDA POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 14.9MG/ML Prescription No No AP 2020/09/09 FRESENIUS KABI USA
214727 001 ANDA POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 14.9MG/ML Prescription No No AP 2021/03/18 NEXUS
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:29.8MG/ML 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
019904 002 NDA POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 29.8MG/ML Prescription Yes Yes AP 1989/12/26 BAXTER HLTHCARE
020161 006 NDA POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 29.8MG/ML Prescription Yes Yes AP 1998/08/11 ICU MEDICAL INC
211087 003 ANDA POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 29.8MG/ML Prescription No No AP 2020/09/09 FRESENIUS KABI USA
214727 003 ANDA POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 29.8MG/ML Prescription No No AP 2021/03/18 NEXUS
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2.98GM/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
019904 004 NDA POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.98GM/100ML Prescription Yes Yes AP 1989/12/26 BAXTER HLTHCARE
020161 004 NDA POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.98GM/100ML Prescription Yes Yes AP 1998/08/11 ICU MEDICAL INC
211087 004 ANDA POTASSIUM CHLORIDE 40MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.98GM/100ML Prescription No No AP 2020/09/09 FRESENIUS KABI USA
214727 005 ANDA POTASSIUM CHLORIDE 40MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 2.98GM/100ML Prescription No No AP 2021/03/18 NEXUS
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:746MG/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
019904 005 NDA POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 746MG/100ML Prescription Yes Yes AP 1990/12/17 BAXTER HLTHCARE
211087 002 ANDA POTASSIUM CHLORIDE 10MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 746MG/100ML Prescription No No AP 2020/09/09 FRESENIUS KABI USA
活性成分:POTASSIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1.49GM/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
019904 006 NDA POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 1.49GM/100ML Prescription Yes Yes AP 1990/12/17 BAXTER HLTHCARE
020161 002 NDA POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER POTASSIUM CHLORIDE INJECTABLE;INJECTION 1.49GM/100ML Prescription Yes Yes AP 1992/11/30 ICU MEDICAL INC
214727 004 ANDA POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 1.49GM/100ML Prescription No No AP 2021/03/18 NEXUS
211087 005 ANDA POTASSIUM CHLORIDE 20MEQ POTASSIUM CHLORIDE INJECTABLE;INJECTION 1.49GM/100ML Prescription No No AP 2021/05/07 FRESENIUS KABI USA
更多信息
药品NDC数据与药品包装、标签说明书
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