Carafate

As of Nov 13, 2026, NDA 18333 (Carafate), held by Abbvie, was first approved by FDA on Oct 30, 1981, with 24 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1981
Review: Priority
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sucralfate is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below


May 11, 1990	Supplement 9Efficacy (new indication or use)	Approved	None posted
Oct 30, 1981	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carafate1GM · tablet;oral	Sucralfate	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Mar 4, 2013	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 26, 2007	Supplement 32Labeling · Standard review	Approved	Label Letter
Nov 29, 1995	Supplement 29Manufacturing · Priority review	Approved	None posted
Aug 15, 1995	Supplement 28Manufacturing · Priority review	Approved	None posted
Jul 14, 1994	Supplement 27Labeling · Standard review	Approved	None posted
Dec 28, 1992	Supplement 26Labeling · Standard review	Approved	None posted
Feb 12, 1991	Supplement 25Labeling	Approved	None posted
Oct 5, 1990	Supplement 24Manufacturing · Priority review	Approved	None posted
May 11, 1990	Supplement 23Labeling	Approved	None posted
May 11, 1990	Supplement 9Efficacy (new indication or use)	Approved	None posted
Dec 19, 1988	Supplement 17Labeling	Approved	None posted
Dec 16, 1988	Supplement 22Manufacturing · Priority review	Approved	None posted
May 5, 1988	Supplement 18Manufacturing · Priority review	Approved	None posted
Aug 5, 1987	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 5, 1987	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 2, 1986	Supplement 14Labeling	Approved	None posted
Sep 24, 1985	Supplement 11Manufacturing · Priority review	Approved	None posted
May 14, 1985	Supplement 8Labeling	Approved	None posted
Sep 24, 1984	Supplement 6Labeling	Approved	None posted
Jun 9, 1983	Supplement 3Manufacturing · Priority review	Approved	None posted
Jun 1, 1983	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 22, 1983	Supplement 5Labeling	Approved	None posted
Aug 16, 1982	Supplement 2Labeling	Approved	None posted
Mar 9, 1982	Supplement 1Manufacturing · Priority review	Approved	None posted
Oct 30, 1981	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18333
Drugs@FDA: Overview at FDA
Company: AbbVie

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