APPLICATION
ANDA074473
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-30
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TOLMETIN SODIUMPrescription
TOLMETIN SODIUM EQ 600MG BASE · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 18 · standardAP
2023-08-31Manufacturing (CMC) · Supplement 17 · unknownAP
2021-04-28Labeling · Supplement 15 · standardAP
2016-05-09Labeling · Supplement 12 · standardAP
2008-07-25Labeling · Supplement 9AP
2006-09-22Labeling · Supplement 6AP
2000-08-02Manufacturing (CMC) · Supplement 4AP
1999-04-30Manufacturing (CMC) · Supplement 3AP
1999-04-30Manufacturing (CMC) · Supplement 2AP
1995-02-01Manufacturing (CMC) · Supplement 1AP
1994-08-30OriginalAP
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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