Details for New Drug Application (NDA): 017610

NDA 017610 describes NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; magnesium acetate; potassium acetate; sodium chloride. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextrose; magnesium acetate; potassium acetate; sodium chloride profile page.

Summary for 017610

Tradename:	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Icu Medical Inc
Ingredient:	dextrose; magnesium acetate; potassium acetate; sodium chloride
Patents:	0

Pharmacology for NDA: 017610

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Suppliers and Packaging for NDA: 017610

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	dextrose; magnesium acetate; potassium acetate; sodium chloride	INJECTABLE;INJECTION	017610	NDA	ICU Medical Inc.	0990-7965	0990-7965-09	12 POUCH in 1 CASE (0990-7965-09) / 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;21MG/100ML;128MG/100ML;234MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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