APPLICATION
ANDA074892
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-16
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 500MG · TABLET · ORAL
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
Approval history
2016-05-09Labeling · Supplement 9 · standardAP
2016-03-25Labeling · Supplement 10 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 8AP
2000-03-21Manufacturing (CMC) · Supplement 6AP
1998-10-29Labeling · Supplement 3AP
1998-10-29Manufacturing (CMC) · Supplement 2AP
1997-04-16OriginalAP
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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