APPLICATION
ANDA073462
TYPE
ANDA
ORIGINAL APPROVAL
1992-04-30
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 7 · standardAP
2021-04-28Labeling · Supplement 6 · standardAP
2021-04-05Labeling · Supplement 5 · standardAP
2016-05-09Labeling · Supplement 4 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 3AP
2001-04-14Manufacturing (CMC) · Supplement 2AP
1994-01-24Manufacturing (CMC) · Supplement 1AP
1992-04-30OriginalAP
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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