Details for New Drug Application (NDA): 018608

NDA 018608 describes PLEGISOL IN PLASTIC CONTAINER, which is a drug marketed by Hospira and is included in one NDA. It is available from one supplier. Additional details are available on the PLEGISOL IN PLASTIC CONTAINER profile page.

The generic ingredient in PLEGISOL IN PLASTIC CONTAINER is calcium chloride; magnesium chloride; potassium chloride; sodium chloride. There are two hundred and eighty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium chloride profile page.

Summary for 018608

Tradename:	PLEGISOL IN PLASTIC CONTAINER
Applicant:	Hospira
Ingredient:	calcium chloride; magnesium chloride; potassium chloride; sodium chloride
Patents:	0

Pharmacology for NDA: 018608

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity 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: 018608

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PLEGISOL IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium chloride	SOLUTION;PERFUSION, CARDIAC	018608	NDA	Hospira, Inc.	0409-7969	0409-7969-05	12 POUCH in 1 CASE (0409-7969-05) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-7969-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;PERFUSION, CARDIAC			Strength	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML
Approval Date:	Feb 26, 1982	TE:	AT	RLD:	Yes

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