APPLICATION
ANDA071891
TYPE
ANDA
ORIGINAL APPROVAL
1988-03-03
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULINDACPrescription
SULINDAC 150MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 47 · standardAP
2024-11-04Labeling · Supplement 45 · standardAP
2021-04-28Labeling · Supplement 44 · standardAP
2016-05-09Labeling · Supplement 41 · standardAP
2015-12-22Labeling · Supplement 40 · standardAP
2008-10-08Labeling · Supplement 27AP
2008-02-05Labeling · Supplement 25AP
2007-06-05Labeling · Supplement 20AP
2006-02-17Labeling · Supplement 19AP
2002-05-15Labeling · Supplement 14AP
2001-10-25Manufacturing (CMC) · Supplement 15AP
2001-04-25Manufacturing (CMC) · Supplement 16AP
2000-01-28Manufacturing (CMC) · Supplement 13AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1999-02-02Manufacturing (CMC) · Supplement 10AP
1990-10-15Manufacturing (CMC) · Supplement 4AP
1990-10-15Manufacturing (CMC) · Supplement 3AP
1990-06-29Manufacturing (CMC) · Supplement 2AP
1990-03-22Labeling · Supplement 7AP
1989-03-07Labeling · Supplement 1AP
1988-03-03OriginalAP
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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