Details for New Drug Application (NDA): 017637

NDA 017637 describes PHYSIOSOL IN PLASTIC CONTAINER, which is a drug marketed by Hospira Inc and Icu Medical Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PHYSIOSOL IN PLASTIC CONTAINER profile page.

The generic ingredient in PHYSIOSOL IN PLASTIC CONTAINER is magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are one hundred and forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.

Summary for 017637

Tradename:	PHYSIOSOL IN PLASTIC CONTAINER
Applicant:	Icu Medical Inc
Ingredient:	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate
Patents:	0

Pharmacology for NDA: 017637

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: 017637

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYSIOSOL IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	SOLUTION;IRRIGATION	017637	NDA	ICU Medical Inc.	0990-6141	0990-6141-09	12 BOTTLE, PLASTIC in 1 CASE (0990-6141-09) / 1000 mL in 1 BOTTLE, PLASTIC

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IRRIGATION			Strength	30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML
Approval Date:	Jul 8, 1982	TE:		RLD:	No

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