APPLICATION
ANDA073311
TYPE
ANDA
ORIGINAL APPROVAL
1991-11-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TOLMETIN SODIUMDiscontinued
TOLMETIN SODIUM EQ 400MG BASE · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 19 · standardAP
2021-04-30Labeling · Supplement 18 · standardAP
2016-05-09Labeling · Supplement 17 · standardAP
2008-04-03Labeling · Supplement 16AP
2006-05-16Labeling · Supplement 15AP
2000-05-16Manufacturing (CMC) · Supplement 5AP
2000-05-16Manufacturing (CMC) · Supplement 4AP
1997-12-05Manufacturing (CMC) · Supplement 3AP
1997-02-24Manufacturing (CMC) · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1991-11-27OriginalAP
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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