APPLICATION
ANDA073393
TYPE
ANDA
ORIGINAL APPROVAL
1993-05-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TOLMETIN SODIUMPrescription
TOLMETIN SODIUM EQ 400MG BASE · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 14 · standardAP
2021-04-28Labeling · Supplement 11 · standardAP
2016-05-09Labeling · Supplement 8 · standardAP
2008-07-31Labeling · Supplement 3AP
2006-08-08Labeling · Supplement 2AP
1998-02-05Manufacturing (CMC) · Supplement 1AP
1993-05-27OriginalAP
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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