Details for New Drug Application (NDA): 214623

NDA 214623 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 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 214623

Tradename:	CARDIOPLEGIC IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	calcium chloride; magnesium chloride; potassium chloride; sodium chloride
Patents:	0

Pharmacology for NDA: 214623

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic 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: 214623

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	214623	ANDA	Fresenius Kabi, USA, LLC	65219-258	65219-258-10	10 POUCH in 1 CASE (65219-258-10) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (65219-258-01)

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 18, 2022	TE:	AT	RLD:	No

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