APPLICATION
ANDA074819
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-28
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 500MG · TABLET · ORAL
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 31 · standardAP
2021-04-28Labeling · Supplement 30 · standardAP
2016-07-22Labeling · Supplement 29 · standardAP
2008-04-25Labeling · Supplement 24AP
2006-08-08Labeling · Supplement 21AP
2002-08-29Manufacturing (CMC) · Supplement 12AP
2001-11-02Manufacturing (CMC) · Supplement 11AP
2001-05-16Manufacturing (CMC) · Supplement 10AP
2001-01-25Manufacturing (CMC) · Supplement 9AP
2000-10-02Manufacturing (CMC) · Supplement 8AP
2000-02-09Manufacturing (CMC) · Supplement 6AP
1999-10-29Manufacturing (CMC) · Supplement 5AP
1999-09-17Labeling · Supplement 7AP
1999-02-01Manufacturing (CMC) · Supplement 4AP
1998-04-28Labeling · Supplement 3AP
1998-04-28Manufacturing (CMC) · Supplement 2AP
1998-02-25Manufacturing (CMC) · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.