← FDA DRUG APPROVALS

FDA ANDA · ANDA074927

ETODOLAC

Sponsor: BIOPHARM

APPLICATION
ANDA074927
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-30
LATEST ACTION
1998-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL

Approval history

1998-10-08Manufacturing (CMC) · Supplement 2AP
1998-10-08Manufacturing (CMC) · Supplement 1AP
1997-10-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →