Carafate

Treats active duodenal ulcer. NDA 19183, held by Abbvie. Sucralfate.

As of Nov 14, 2026, NDA 19183 (Carafate), held by Abbvie, was first approved by FDA on Dec 16, 1993, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 16, 1993
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 16, 1993	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carafate1GM/10ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suspension;oral	Sucralfate	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


May 12, 2023	Supplement 21Labeling · Standard review	Approved	Label Letter
Aug 15, 2017	Supplement 19Labeling · Standard review	Approved	Letter Label
Jun 6, 2016	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 4, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 21, 2010	Supplement 14Labeling	Approved	Letter Label
Apr 26, 2007	Supplement 11Labeling · Standard review	Approved	Label Letter
Feb 10, 2006	Supplement 9Manufacturing · Standard review	Approved	Letter
Feb 8, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 14, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 16, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 21, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 13, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Apr 11, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 16, 1993	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 19183
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