Application 017610

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7965	Normosol-M and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7965	Normosol-M and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE	Hospira, Inc.	NDA	Current
0409-7965	Normosol-M and Dextrose	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE	Hospira, Inc.	NDA	Current
0990-7965	NORMOSOL-M AND DEXTROSE	dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate	ICU Medical Inc.	NDA	Current
0990-7965	NORMOSOL-M AND DEXTROSE	dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate	ICU Medical Inc.	NDA	Current
0990-7965	NORMOSOL-M AND DEXTROSE	dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate	ICU Medical Inc.	NDA	Current
0990-7965	NORMOSOL-M AND DEXTROSE	dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate	ICU Medical Inc.	NDA	Current