APPLICATION
ANDA073262
TYPE
ANDA
ORIGINAL APPROVAL
1991-09-06
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 23 · standardAP
2021-05-07Labeling · Supplement 22 · standardAP
2016-05-09Labeling · Supplement 21 · standardAP
2009-06-24Labeling · Supplement 20AP
2007-12-20Labeling · Supplement 18AP
1997-06-23Manufacturing (CMC) · Supplement 8AP
1995-02-13Manufacturing (CMC) · Supplement 7AP
1994-07-05Manufacturing (CMC) · Supplement 6AP
1994-07-05Manufacturing (CMC) · Supplement 5AP
1993-12-17Manufacturing (CMC) · Supplement 4AP
1991-09-06OriginalAP
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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