Details for New Drug Application (NDA): 211221

NDA 211221 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.225%, which is a drug marketed by Fresenius Kabi Usa, Abbott, and Icu Medical Inc, and is included in three NDAs. It is available from one supplier. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.225% profile page.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.225% is dextrose; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

Summary for 211221

Tradename:	DEXTROSE 5% AND SODIUM CHLORIDE 0.225%
Applicant:	Fresenius Kabi Usa
Ingredient:	dextrose; sodium chloride
Patents:	0

Pharmacology for NDA: 211221

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 211221

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% AND SODIUM CHLORIDE 0.225%	dextrose; sodium chloride	INJECTABLE;INJECTION	211221	ANDA	Fresenius Kabi USA, LLC	63323-873	63323-873-10	10 BAG in 1 CASE (63323-873-10) / 1000 mL in 1 BAG
DEXTROSE 5% AND SODIUM CHLORIDE 0.225%	dextrose; sodium chloride	INJECTABLE;INJECTION	211221	ANDA	Fresenius Kabi USA, LLC	63323-873	63323-873-74	20 BAG in 1 CASE (63323-873-74) / 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/100ML;225MG/100ML
Approval Date:	Sep 15, 2020	TE:	AP	RLD:	No

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