APPLICATION
ANDA075696
TYPE
ANDA
ORIGINAL APPROVAL
2000-07-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2021-04-28Labeling · Supplement 16 · standardAP
2016-05-09Labeling · Supplement 15 · standardAP
2016-02-05Labeling · Supplement 14 · standardAP
2004-09-23Labeling · Supplement 10AP
2001-11-02Manufacturing (CMC) · Supplement 4AP
2001-10-05Manufacturing (CMC) · Supplement 2AP
2001-05-07Manufacturing (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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