Details for New Drug Application (NDA): 211276

NDA 211276 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, which is a drug marketed by Fresenius Kabi Usa, Abbott, B Braun, Miles, and Otsuka Icu Medcl, and is included in six NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.45% profile page.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.45% is dextrose; sodium chloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

Summary for 211276

Tradename:	DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
Applicant:	Fresenius Kabi Usa
Ingredient:	dextrose; sodium chloride
Patents:	0

Pharmacology for NDA: 211276

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

Suppliers and Packaging for NDA: 211276

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; sodium chloride	INJECTABLE;INJECTION	211276	ANDA	BECTON DICKINSON AND COMPANY	17271-734	17271-734-05	30 BAG in 1 CASE (17271-734-05) / 250 mL in 1 BAG
DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; sodium chloride	INJECTABLE;INJECTION	211276	ANDA	BECTON DICKINSON AND COMPANY	17271-734	17271-734-06	20 BAG in 1 CASE (17271-734-06) / 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/100ML;450MG/100ML
Approval Date:	Sep 15, 2020	TE:	AP	RLD:	No

Complete Access Available with Subscription