Application 017484

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER	DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current
0338-0143	Dextrose and Electrolyte No. 48	Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate	Baxter Healthcare Corporation	NDA	Current