Details for New Drug Application (NDA): 018895

NDA 018895 describes TPN ELECTROLYTES IN PLASTIC CONTAINER, which is a drug marketed by Abbott and Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the TPN ELECTROLYTES IN PLASTIC CONTAINER profile page.

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

Summary for 018895

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

Pharmacology for NDA: 018895

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: 018895

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TPN ELECTROLYTES IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride	INJECTABLE;INJECTION	018895	NDA	Hospira, Inc.	0409-5779	0409-5779-01	25 VIAL, SINGLE-DOSE in 1 CARTON (0409-5779-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-5779-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML
Approval Date:	Jul 20, 1984	TE:		RLD:	Yes

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