Details for New Drug Application (NDA): 075323

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NDA 075323 describes CARDIOPLEGIC IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Fresenius Kabi Usa and is included in two NDAs. It is available from two suppliers. Additional details are available on the CARDIOPLEGIC IN PLASTIC CONTAINER profile page.

The generic ingredient in CARDIOPLEGIC IN PLASTIC CONTAINER is calcium chloride; magnesium chloride; potassium chloride; sodium chloride. There is one drug master file entry 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 075323

Tradename:	CARDIOPLEGIC IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare
Ingredient:	calcium chloride; magnesium chloride; potassium chloride; sodium chloride
Patents:	0

Pharmacology for NDA: 075323

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: 075323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDIOPLEGIC IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium chloride	SOLUTION;PERFUSION, CARDIAC	075323	ANDA	Baxter Healthcare Corporation	0338-0341	0338-0341-04	14 BAG in 1 CARTON (0338-0341-04) / 1000 mL in 1 BAG

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:	Apr 21, 2000	TE:	AT	RLD:	No

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