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FDA ANDA · ANDA073519

TOLMETIN SODIUM

Sponsor: ANI PHARMS

APPLICATION
ANDA073519
TYPE
ANDA
ORIGINAL APPROVAL
1992-05-29
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TOLMETIN SODIUMDiscontinued
TOLMETIN SODIUM EQ 400MG BASE · CAPSULE · ORAL

Approval history

2021-04-28Labeling · Supplement 10 · standardAP
2016-05-09Labeling · Supplement 9 · standardAP
1999-12-02Manufacturing (CMC) · Supplement 7AP
1999-12-02Manufacturing (CMC) · Supplement 8AP
1999-02-12Manufacturing (CMC) · Supplement 3AP
1999-02-12Manufacturing (CMC) · Supplement 2AP
1996-08-16Manufacturing (CMC) · Supplement 1AP
1992-05-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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