APPLICATION
ANDA072713
TYPE
ANDA
ORIGINAL APPROVAL
1991-08-30
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULINDACDiscontinued
SULINDAC 200MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 15 · standardAP
2021-04-28Labeling · Supplement 14 · standardAP
2021-04-19Labeling · Supplement 13 · standardAP
2016-05-09Labeling · Supplement 12 · standardAP
2002-12-16Manufacturing (CMC) · Supplement 8AP
2002-04-19Manufacturing (CMC) · Supplement 7AP
2001-08-31Manufacturing (CMC) · Supplement 6AP
1999-05-05Manufacturing (CMC) · Supplement 5AP
1997-10-03Manufacturing (CMC) · Supplement 4AP
1996-04-26Labeling · Supplement 3AP
1994-01-24Manufacturing (CMC) · Supplement 2AP
1992-08-07Manufacturing (CMC) · Supplement 1AP
1991-08-30OriginalAP
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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