APPLICATION
ANDA074903
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-11
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ETODOLACPrescription
ETODOLAC 500MG · TABLET · ORAL
ETODOLACPrescription
ETODOLAC 400MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 34 · standardAP
2021-04-28Labeling · Supplement 30 · standardAP
2016-05-09Labeling · Supplement 25 · standardAP
2015-06-02Labeling · Supplement 23 · standardAP
2007-02-26Labeling · Supplement 13AP
2006-03-02Labeling · Supplement 11AP
2002-09-20Manufacturing (CMC) · Supplement 8AP
2000-02-02Manufacturing (CMC) · Supplement 7AP
1999-04-19Labeling · Supplement 6AP
1999-04-19Manufacturing (CMC) · Supplement 4AP
1999-04-19Manufacturing (CMC) · Supplement 2AP
1999-04-19Manufacturing (CMC) · Supplement 5AP
1999-04-19Manufacturing (CMC) · Supplement 3AP
1998-12-07Manufacturing (CMC) · Supplement 1AP
1997-04-11OriginalAP
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.