POTASSIUM PHOSPHATES-美国FDA药品数据库-药物在线

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 PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	Yes	Yes	AP	2019/11/26	2019/11/26	Prescription
002	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	Yes	Yes	AP		2019/11/26	Prescription
003	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	Yes	Yes	AP		2019/11/26	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
2019/11/26	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label Letter Review

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 PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/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	RLD	RS	TE Code	产品号批准日期	申请人
212832	001	NDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	Prescription	Yes	Yes	AP	2019/11/26	FRESENIUS KABI USA
216274	001	ANDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	Prescription	No	No	AP	2023/10/02	AM REGENT
216344	001	ANDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	Prescription	No	No	AP	2023/10/10	AMNEAL

活性成分:POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/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	RLD	RS	TE Code	产品号批准日期	申请人
212832	002	NDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	Prescription	Yes	Yes	AP	2019/11/26	FRESENIUS KABI USA
216274	002	ANDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	Prescription	No	No	AP	2023/10/02	AM REGENT
216344	002	ANDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	Prescription	No	No	AP	2023/10/10	AMNEAL

活性成分:POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/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	RLD	RS	TE Code	产品号批准日期	申请人
212832	003	NDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	Prescription	Yes	Yes	AP	2019/11/26	FRESENIUS KABI USA
216274	003	ANDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	Prescription	No	No	AP	2023/10/02	AM REGENT
216344	003	ANDA	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	Prescription	No	No	AP	2023/10/10	AMNEAL