Gaviscon

NDA 18685, held by Chattem Sanofi. Aluminum Hydroxide; Magnesium Trisilicate.

As of Nov 13, 2026, NDA 18685 (Gaviscon), held by Chattem Sanofi, was first approved by FDA on Dec 9, 1983, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 9, 1983
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 9, 1983	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Gaviscon80MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Aluminum Hydroxide; Magnesium Trisilicate	DiscontinuedReference drug
Gaviscon160MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, chewable;oral	Aluminum Hydroxide; Magnesium Trisilicate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 13, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 8, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 22, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 28, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 7, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 4, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 29, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 17, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 1, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 1, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 25, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Oct 1, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 8, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 25, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 1, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 9, 1983	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18685
Drugs@FDA: Overview at FDA
Company: Chattem Sanofi

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters