← FDA DRUG APPROVALS

FDA NDA · NDA019183

CARAFATE

sucralfate

Sponsor: ABBVIE

APPLICATION
NDA019183
TYPE
NDA
ORIGINAL APPROVAL
1993-12-16
LATEST ACTION
2023-05-12
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

CARAFATE · ReferenceDiscontinued
SUCRALFATE 1GM/10ML · SUSPENSION · ORAL

Approval history

2023-05-12Labeling · Supplement 21 · standard — Label ↗AP
2017-08-15Labeling · Supplement 19 · standard — Label ↗AP
2016-06-06Manufacturing (CMC) · Supplement 18 · standardAP
2013-03-04Labeling · Supplement 16 · standard — Label ↗AP
2010-12-21Labeling · Supplement 14 · unknown — Label ↗AP
2007-04-26Labeling · Supplement 11 · standard — Label ↗AP
2006-02-10Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2000-02-08Manufacturing (CMC) · Supplement 7 · standardAP
1997-08-14Manufacturing (CMC) · Supplement 4 · standardAP
1997-07-16Manufacturing (CMC) · Supplement 6 · standardAP
1995-08-21Manufacturing (CMC) · Supplement 3 · standardAP
1994-07-13Labeling · Supplement 2 · standardAP
1994-04-11Manufacturing (CMC) · Supplement 1 · standardAP
1993-12-16Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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