APPLICATION
ANDA072711
TYPE
ANDA
ORIGINAL APPROVAL
1991-03-25
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SULINDACPrescription
SULINDAC 200MG · TABLET · ORAL
SULINDACPrescription
SULINDAC 150MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 18 · standardAP
2024-10-08Labeling · Supplement 17 · standardAP
2021-04-28Labeling · Supplement 16 · standardAP
2016-05-09Labeling · Supplement 10 · standardAP
2015-05-28Labeling · Supplement 9 · standardAP
2010-07-15Labeling · Supplement 7AP
2009-10-01Labeling · Supplement 5AP
1998-05-13Manufacturing (CMC) · Supplement 4AP
1996-02-12Manufacturing (CMC) · Supplement 3AP
1992-02-27Labeling · Supplement 2AP
1991-05-06Labeling · Supplement 1AP
1991-03-25OriginalAP
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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