APPLICATION
NDA017911
TYPE
NDA
ORIGINAL APPROVAL
1978-09-27
LATEST ACTION
2010-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLINORIL · ReferenceDiscontinued
SULINDAC 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CLINORIL · ReferenceDiscontinued
SULINDAC 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-10-30Labeling · Supplement 66 · standardAP
2001-02-07Manufacturing (CMC) · Supplement 67 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 63 · standardAP
1997-04-14Manufacturing (CMC) · Supplement 64 · standardAP
1996-03-01Manufacturing (CMC) · Supplement 62 · standardAP
1995-07-10Labeling · Supplement 58 · standardAP
1995-06-01Labeling · Supplement 57 · standardAP
1994-10-24Manufacturing (CMC) · Supplement 60 · standardAP
1994-08-18Manufacturing (CMC) · Supplement 59 · standardAP
1993-05-12Manufacturing (CMC) · Supplement 15 · standardAP
1992-07-27Manufacturing (CMC) · Supplement 55 · standardAP
1989-05-31Labeling · Supplement 51 · standardAP
1989-05-31Labeling · Supplement 27 · standardAP
1989-05-31Labeling · Supplement 52 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 49 · standardAP
1989-01-09Labeling · Supplement 40 · standardAP
1989-01-09Labeling · Supplement 47 · standardAP
1989-01-09Labeling · Supplement 43 · standardAP
1989-01-09Labeling · Supplement 46 · standardAP
1989-01-09Labeling · Supplement 44 · standardAP
1989-01-09Labeling · Supplement 50 · standardAP
1988-05-03Manufacturing (CMC) · Supplement 45 · standardAP
1986-02-05Labeling · Supplement 37 · standardAP
1986-02-05Labeling · Supplement 35 · standardAP
1986-02-05Labeling · Supplement 38 · standardAP
1984-11-26Labeling · Supplement 34 · standardAP
1984-11-20Manufacturing (CMC) · Supplement 16 · standardAP
1984-08-13Manufacturing (CMC) · Supplement 25 · standardAP
1984-07-26Manufacturing (CMC) · Supplement 33 · standardAP
1984-05-29Manufacturing (CMC) · Supplement 23 · standardAP
1984-01-26Labeling · Supplement 31 · standardAP
1983-06-29Manufacturing (CMC) · Supplement 22 · standardAP
1982-06-29Labeling · Supplement 17 · standardAP
1982-06-22Labeling · Supplement 18 · standardAP
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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