Details for New Drug Application (NDA): 018883

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NDA 018883 describes DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER profile page.

The generic ingredient in DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. 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; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.

Tradename:	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
Applicant:	Fresenius Medcl
Ingredient:	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate
Patents:	0

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

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018883	NDA	Fresenius Medical Care North America	49230-188	49230-188-50	2 BAG in 1 CARTON (49230-188-50) / 5000 mL in 1 BAG
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018883	NDA	Fresenius Medical Care North America	49230-188	49230-188-52	2 BAG in 1 CARTON (49230-188-52) / 5000 mL in 1 BAG

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:	Nov 30, 1984	TE:	AT	RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:	Nov 30, 1984	TE:	AT	RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:	Nov 30, 1984	TE:	AT	RLD:	Yes

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