APPLICATION
ANDA074942
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-30
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 200MG · CAPSULE · ORAL
ETODOLACDiscontinued
ETODOLAC 300MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 6 · standardAP
2021-04-28Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 3 · standardAP
2000-04-17Manufacturing (CMC) · Supplement 2AP
1998-10-08Manufacturing (CMC) · Supplement 1AP
1997-09-30OriginalAP
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.
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.