APPLICATION
ANDA073038
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-22
LATEST ACTION
2002-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULINDACDiscontinued
SULINDAC 150MG · TABLET · ORAL
Approval history
2002-09-18Labeling · Supplement 3AP
1998-02-05Manufacturing (CMC) · Supplement 2AP
1996-04-18Labeling · Supplement 1AP
1993-06-22OriginalAP
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.