APPLICATION
ANDA075126
TYPE
ANDA
ORIGINAL APPROVAL
1999-09-16
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ETODOLACPrescription
ETODOLAC 200MG · CAPSULE · ORAL
ETODOLACPrescription
ETODOLAC 300MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 20 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2016-05-09Labeling · Supplement 9 · standardAP
2013-02-07Labeling · Supplement 5AP
2007-01-11Labeling · Supplement 3AP
2006-03-02Labeling · Supplement 2AP
2002-05-08Manufacturing (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.