APPLICATION
ANDA074841
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 4 · standardAP
2021-04-28Labeling · Supplement 3 · standardAP
2016-05-09Labeling · Supplement 2 · standardAP
2002-11-15Manufacturing (CMC) · Supplement 1AP
1997-06-27OriginalAP
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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