APPLICATION
ANDA074415
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-08
LATEST ACTION
2015-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SUCRALFATEPrescription
SUCRALFATE 1GM · TABLET · ORAL
Approval history
2015-10-30Labeling · Supplement 19 · standardAP
2008-01-16Labeling · Supplement 8AP
2007-09-19Labeling · Supplement 6AP
2000-02-02Manufacturing (CMC) · Supplement 2AP
2000-02-02Manufacturing (CMC) · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.