Details for New Drug Application (NDA): 020183

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NDA 020183 describes DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, which is a drug marketed by Vantive Us Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER profile page.

The generic ingredient in DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% 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. Four suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.

Tradename:	DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Applicant:	Vantive Us Hlthcare
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
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	020183	NDA	Vantive US Healthcare LLC	0941-0424	0941-0424-51	1500 mL in 1 BAG (0941-0424-51)
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	020183	NDA	Vantive US Healthcare LLC	0941-0424	0941-0424-52	2000 mL in 1 BAG (0941-0424-52)

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Approval Date:	Dec 4, 1992	TE:	AT	RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Approval Date:	Dec 4, 1992	TE:	AT	RLD:	Yes

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
Approval Date:	Dec 4, 1992	TE:		RLD:	Yes

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