APPLICATION
ANDA074932
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-16
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 300MG · CAPSULE · ORAL
ETODOLACDiscontinued
ETODOLAC 200MG · CAPSULE · ORAL
Approval history
2024-11-21Labeling · Supplement 10 · standardAP
2021-04-28Labeling · Supplement 8 · standardAP
2016-05-09Labeling · Supplement 7 · standardAP
2015-12-17Labeling · Supplement 6 · standardAP
2002-10-29Manufacturing (CMC) · Supplement 4AP
2002-07-11Manufacturing (CMC) · Supplement 3AP
2001-01-29Manufacturing (CMC) · Supplement 2AP
1997-05-16OriginalAP
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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