Application 212832

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	Yes	Yes
002	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	Yes	Yes
003	POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	Yes	Yes
004	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)	Yes	Yes
005	POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	SOLUTION;INTRAVENOUS	1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65219-052	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-052	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-054	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-054	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-056	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current
65219-056	Potassium Phosphates	Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic	Fresenius Kabi USA, LLC	NDA	Current