Details for New Drug Application (NDA): 076491

NDA 076491 describes TRILYTE, which is a drug marketed by Aurobindo Pharma Usa and is included in one NDA. It is available from one supplier. Additional details are available on the TRILYTE profile page.

The generic ingredient in TRILYTE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.

Summary for 076491

Tradename:	TRILYTE
Applicant:	Aurobindo Pharma Usa
Ingredient:	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride
Patents:	0

Pharmacology for NDA: 076491

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Suppliers and Packaging for NDA: 076491

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRILYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	076491	ANDA	Aurobindo Pharma Limited	84386-013	84386-013-04	4 L in 1 BOTTLE (84386-013-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Approval Date:	Feb 5, 2004	TE:		RLD:	No

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