Details for New Drug Application (NDA): 017512

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NDA 017512 describes DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER profile page.

The generic ingredient in DIANEAL PD-2 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. 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:	DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Applicant:	Baxter 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 Acidifying 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 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	017512	NDA	Baxter Healthcare Corporation	0941-0409	0941-0409-01	6000 mL in 1 BAG (0941-0409-01)
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	017512	NDA	Baxter Healthcare Corporation	0941-0409	0941-0409-05	3000 mL in 1 BAG (0941-0409-05)

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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