← FDA DRUG APPROVALS

FDA ANDA · ANDA214872

ETODOLAC

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA214872
TYPE
ANDA
ORIGINAL APPROVAL
2026-07-15
LATEST ACTION
2026-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ETODOLACPrescription
ETODOLAC 500MG · TABLET · ORAL
ETODOLACPrescription
ETODOLAC 400MG · TABLET · ORAL

Approval history

2026-07-15UNKNOWN · Original · standardAP
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 →