APPLICATION
ANDA073392
TYPE
ANDA
ORIGINAL APPROVAL
1992-01-24
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 5 · standardAP
2021-04-28Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 3 · standardAP
2002-07-29Manufacturing (CMC) · Supplement 2AP
1992-01-24OriginalAP
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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