APPLICATION
ANDA072050
TYPE
ANDA
ORIGINAL APPROVAL
1991-04-17
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 41 · standardAP
2021-04-30Labeling · Supplement 40 · standardAP
2016-05-09Labeling · Supplement 35 · standardAP
2015-04-15Labeling · Supplement 32AP
2010-07-30Labeling · Supplement 31AP
2009-06-08Labeling · Supplement 30AP
2007-12-20Labeling · Supplement 27AP
2006-04-03Labeling · Supplement 25AP
2002-10-22Labeling · Supplement 14AP
2002-05-01Manufacturing (CMC) · Supplement 13AP
2002-03-13Manufacturing (CMC) · Supplement 12AP
2001-08-28Manufacturing (CMC) · Supplement 10AP
2001-05-16Labeling · Supplement 11AP
2000-10-02Manufacturing (CMC) · Supplement 8AP
2000-10-02Labeling · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 6AP
2000-05-16Manufacturing (CMC) · Supplement 7AP
2000-03-07Manufacturing (CMC) · Supplement 5AP
1997-12-05Manufacturing (CMC) · Supplement 4AP
1997-02-24Manufacturing (CMC) · Supplement 3AP
1995-06-22Manufacturing (CMC) · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1991-04-17OriginalAP
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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