APPLICATION
NDA018445
TYPE
NDA
ORIGINAL APPROVAL
1982-04-19
LATEST ACTION
2007-03-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DOLOBID · ReferenceDiscontinued
DIFLUNISAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DOLOBID · ReferenceDiscontinued
DIFLUNISAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1998-05-15Labeling · Supplement 53 · priorityAP
1998-05-15Labeling · Supplement 52 · priorityAP
1997-12-01Manufacturing (CMC) · Supplement 54 · priorityAP
1997-04-17Labeling · Supplement 50 · priorityAP
1996-03-01Manufacturing (CMC) · Supplement 51 · priorityAP
1994-08-22Labeling · Supplement 47 · priorityAP
1994-08-22Labeling · Supplement 48 · priorityAP
1994-08-22Labeling · Supplement 46 · priorityAP
1994-08-18Manufacturing (CMC) · Supplement 49 · priorityAP
1994-03-28Manufacturing (CMC) · Supplement 28 · priorityAP
1991-12-06Manufacturing (CMC) · Supplement 43 · priorityAP
1991-12-06Labeling · Supplement 44 · priorityAP
1991-11-19Manufacturing (CMC) · Supplement 42 · priorityAP
1989-04-21Manufacturing (CMC) · Supplement 37 · priorityAP
1989-04-21Manufacturing (CMC) · Supplement 22 · priorityAP
1989-01-09Manufacturing (CMC) · Supplement 38 · priorityAP
1989-01-09Labeling · Supplement 36 · priorityAP
1989-01-09Labeling · Supplement 40 · priorityAP
1988-05-03Manufacturing (CMC) · Supplement 35 · priorityAP
1988-02-02Labeling · Supplement 27 · priorityAP
1988-02-02Labeling · Supplement 33 · priorityAP
1988-02-02Labeling · Supplement 31 · priorityAP
1988-02-02Labeling · Supplement 34 · priorityAP
1988-02-02Labeling · Supplement 32 · priorityAP
1988-02-02Labeling · Supplement 24 · priorityAP
1988-02-02Labeling · Supplement 30 · priorityAP
1986-08-15Labeling · Supplement 25 · priorityAP
1986-08-15Labeling · Supplement 26 · priorityAP
1986-02-03Manufacturing (CMC) · Supplement 21 · priorityAP
1986-02-03Manufacturing (CMC) · Supplement 1 · priorityAP
1985-09-30Manufacturing (CMC) · Supplement 19 · priorityAP
1985-02-21Manufacturing (CMC) · Supplement 17 · priorityAP
1985-02-21Manufacturing (CMC) · Supplement 18 · priorityAP
1985-01-09Labeling · Supplement 8 · priorityAP
1984-12-11Manufacturing (CMC) · Supplement 12 · priorityAP
1984-11-20Manufacturing (CMC) · Supplement 16 · priorityAP
1984-10-03Manufacturing (CMC) · Supplement 15 · priorityAP
1984-06-25Manufacturing (CMC) · Supplement 9 · priorityAP
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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