Details for New Drug Application (NDA): 018685

NDA 018685 describes GAVISCON, which is a drug marketed by Chattem Sanofi and is included in one NDA. It is available from one supplier. Additional details are available on the GAVISCON profile page.

The generic ingredient in GAVISCON is aluminum hydroxide; magnesium trisilicate. There are one hundred and forty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aluminum hydroxide; magnesium trisilicate profile page.

Summary for 018685

Tradename:	GAVISCON
Applicant:	Chattem Sanofi
Ingredient:	aluminum hydroxide; magnesium trisilicate
Patents:	0

Pharmacology for NDA: 018685

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	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: 018685

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GAVISCON	aluminum hydroxide; magnesium trisilicate	TABLET, CHEWABLE;ORAL	018685	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0135-0096	0135-0096-26	100 TABLET, CHEWABLE in 1 BOTTLE (0135-0096-26)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	80MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Dec 9, 1983	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	160MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Dec 9, 1983	TE:		RLD:	Yes

Complete Access Available with Subscription