APPLICATION
ANDA074844
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-23
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 300MG · CAPSULE · ORAL
ETODOLACDiscontinued
ETODOLAC 200MG · CAPSULE · ORAL
Approval history
2021-04-28Labeling · Supplement 6 · standardAP
2016-05-09Labeling · Supplement 4 · standardAP
2015-12-21Labeling · Supplement 5 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 3AP
2000-03-21Manufacturing (CMC) · Supplement 1AP
1997-12-23OriginalAP
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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