APPLICATION
NDA018333
TYPE
NDA
ORIGINAL APPROVAL
1981-10-30
LATEST ACTION
2013-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARAFATE · ReferencePrescription
SUCRALFATE 1GM · TABLET · ORAL
Approval history
1995-11-29Manufacturing (CMC) · Supplement 29 · priorityAP
1995-08-15Manufacturing (CMC) · Supplement 28 · priorityAP
1994-07-14Labeling · Supplement 27 · standardAP
1992-12-28Labeling · Supplement 26 · standardAP
1991-02-12Labeling · Supplement 25AP
1990-10-05Manufacturing (CMC) · Supplement 24 · priorityAP
1990-05-11Labeling · Supplement 23AP
1990-05-11Efficacy · Supplement 9AP
1988-12-19Labeling · Supplement 17AP
1988-12-16Manufacturing (CMC) · Supplement 22 · priorityAP
1988-05-05Manufacturing (CMC) · Supplement 18 · priorityAP
1987-08-05Manufacturing (CMC) · Supplement 12 · priorityAP
1987-08-05Manufacturing (CMC) · Supplement 10 · priorityAP
1986-07-02Labeling · Supplement 14AP
1985-09-24Manufacturing (CMC) · Supplement 11 · priorityAP
1985-05-14Labeling · Supplement 8AP
1984-09-24Labeling · Supplement 6AP
1983-06-09Manufacturing (CMC) · Supplement 3 · priorityAP
1983-06-01Manufacturing (CMC) · Supplement 4 · priorityAP
1983-04-22Labeling · Supplement 5AP
1982-08-16Labeling · Supplement 2AP
1982-03-09Manufacturing (CMC) · Supplement 1 · priorityAP
1981-10-30Type 1 - New Molecular Entity · Original · priorityAP
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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