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FDA ANDA · ANDA074840

ETODOLAC

Sponsor: ANI PHARMS

APPLICATION
ANDA074840
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-29
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ETODOLACDiscontinued
ETODOLAC 300MG · CAPSULE · ORAL
ETODOLACDiscontinued
ETODOLAC 200MG · CAPSULE · ORAL

Approval history

2021-04-28Labeling · Supplement 5 · standardAP
2016-05-09Labeling · Supplement 3 · standardAP
2001-04-26Manufacturing (CMC) · Supplement 2AP
1999-08-26Manufacturing (CMC) · Supplement 1AP
1997-08-29OriginalAP
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.

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