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FDA ANDA · ANDA074883

ETODOLAC

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA074883
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-28
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
ETODOLACDiscontinued
ETODOLAC 500MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 21AP
2002-03-12Manufacturing (CMC) · Supplement 20AP
2000-01-28Manufacturing (CMC) · Supplement 18AP
1999-10-22Manufacturing (CMC) · Supplement 16AP
1999-10-22Manufacturing (CMC) · Supplement 14AP
1999-10-22Manufacturing (CMC) · Supplement 17AP
1999-10-22Manufacturing (CMC) · Supplement 15AP
1999-10-22Manufacturing (CMC) · Supplement 13AP
1999-07-21Manufacturing (CMC) · Supplement 12AP
1999-07-21Manufacturing (CMC) · Supplement 10AP
1999-07-21Manufacturing (CMC) · Supplement 9AP
1999-07-21Manufacturing (CMC) · Supplement 11AP
1999-07-21Manufacturing (CMC) · Supplement 8AP
1998-12-09Manufacturing (CMC) · Supplement 7AP
1998-11-20Manufacturing (CMC) · Supplement 4AP
1998-11-20Manufacturing (CMC) · Supplement 5AP
1998-11-20Labeling · Supplement 6AP
1998-02-25Manufacturing (CMC) · Supplement 2AP
1998-01-20Manufacturing (CMC) · Supplement 3AP
1997-11-07Manufacturing (CMC) · Supplement 1AP
1997-02-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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