APPLICATION
ANDA075104
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-06
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
ETODOLACDiscontinued
ETODOLAC 500MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 12 · standardAP
2021-04-28Labeling · Supplement 10 · standardAP
2016-05-09Labeling · Supplement 9 · standardAP
2015-12-03Labeling · Supplement 8 · standardAP
2007-11-13Labeling · Supplement 7AP
2006-07-28Labeling · Supplement 5AP
2002-07-11Manufacturing (CMC) · Supplement 4AP
1998-11-20Labeling · Supplement 2AP
1998-11-20Manufacturing (CMC) · Supplement 3AP
1998-11-20Manufacturing (CMC) · Supplement 1AP
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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