APPLICATION
ANDA074846
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-28
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
Approval history
2021-04-28Labeling · Supplement 9 · standardAP
2016-05-09Labeling · Supplement 8 · standardAP
2000-04-11Labeling · Supplement 3AP
2000-03-03Manufacturing (CMC) · Supplement 2AP
1997-12-16Manufacturing (CMC) · Supplement 1AP
1997-02-28OriginalAP
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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