Details for New Drug Application (NDA): 017585

NDA 017585 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Abbott, B Braun, Miles, and Otsuka Icu Medcl, and is included in five NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 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 017585

Tradename:	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:	Otsuka Icu Medcl
Ingredient:	dextrose; sodium chloride
Patents:	0

Pharmacology for NDA: 017585

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

Suppliers and Packaging for NDA: 017585

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	017585	NDA	ICU Medical Inc.	0990-7941	0990-7941-03	24 POUCH in 1 CASE (0990-7941-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	017585	NDA	ICU Medical Inc.	0990-7941	0990-7941-09	12 POUCH in 1 CASE (0990-7941-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/100ML;900MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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