Details for New Drug Application (NDA): 021321

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NDA 021321 describes EXTRANEAL, 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 EXTRANEAL profile page.

The generic ingredient in EXTRANEAL is icodextrin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the icodextrin profile page.

Summary for 021321

Tradename:	EXTRANEAL
Applicant:	Vantive Us Hlthcare
Ingredient:	icodextrin
Patents:	0

Pharmacology for NDA: 021321

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: 021321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321	NDA	Vantive US Healthcare LLC	0941-0679	0941-0679-05	2500 mL in 1 BAG (0941-0679-05)
EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321	NDA	Vantive US Healthcare LLC	0941-0679	0941-0679-06	2000 mL in 1 BAG (0941-0679-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAPERITONEAL			Strength	7.5GM/100ML
Approval Date:	Dec 20, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021321

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002	4,761,237	⤷ Get Started Free
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002	6,248,726	⤷ Get Started Free
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002	6,077,836	⤷ Get Started Free
Vantive Us Hlthcare	EXTRANEAL	icodextrin	SOLUTION;INTRAPERITONEAL	021321-001	Dec 20, 2002	4,886,789	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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