APPLICATION
ANDA073290
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
2021-04-28Labeling · Supplement 18 · standardAP
2016-05-09Labeling · Supplement 17 · standardAP
2007-01-11Labeling · Supplement 13AP
2006-03-08Labeling · Supplement 12AP
1998-03-17Manufacturing (CMC) · Supplement 4AP
1994-07-22Manufacturing (CMC) · Supplement 2AP
1994-07-18Manufacturing (CMC) · Supplement 3AP
1994-03-31Manufacturing (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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