APPLICATION
ANDA073527
TYPE
ANDA
ORIGINAL APPROVAL
1992-06-30
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLMETIN SODIUMDiscontinued
TOLMETIN SODIUM EQ 600MG BASE · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2021-04-28Labeling · Supplement 16 · standardAP
2016-05-09Labeling · Supplement 15 · standardAP
2016-01-27Labeling · Supplement 14 · standardAP
2002-01-28Manufacturing (CMC) · Supplement 5AP
2001-11-02Manufacturing (CMC) · Supplement 4AP
2000-07-13Manufacturing (CMC) · Supplement 3AP
2000-02-03Manufacturing (CMC) · Supplement 2AP
1996-01-18Manufacturing (CMC) · Supplement 1AP
1992-06-30OriginalAP
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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