APPLICATION
ANDA073039
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-22
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULINDACDiscontinued
SULINDAC 200MG · TABLET · ORAL
SULINDACDiscontinued
SULINDAC 150MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 24 · standardAP
2021-04-28Labeling · Supplement 22 · standardAP
2016-05-09Labeling · Supplement 18 · standardAP
2015-12-22Labeling · Supplement 17 · standardAP
2010-08-13Labeling · Supplement 16AP
2008-05-08Labeling · Supplement 10AP
2006-05-16Labeling · Supplement 8AP
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.
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