← FDA DRUG APPROVALS

FDA ANDA · ANDA075943

ETODOLAC

Sponsor: ANI PHARMS

APPLICATION
ANDA075943
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-26
LATEST ACTION
2002-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ETODOLACDiscontinued
ETODOLAC 600MG · TABLET, EXTENDED RELEASE · ORAL
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET, EXTENDED RELEASE · ORAL
ETODOLACDiscontinued
ETODOLAC 500MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-11-22Manufacturing (CMC) · Supplement 1AP
2002-07-26OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →