APPLICATION
ANDA075226
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-24
LATEST ACTION
2001-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETODOLACDiscontinued
ETODOLAC 400MG · TABLET · ORAL
ETODOLACDiscontinued
ETODOLAC 500MG · TABLET · ORAL
Approval history
2001-02-08Manufacturing (CMC) · Supplement 4AP
2001-01-22Labeling · Supplement 5AP
2000-12-20Manufacturing (CMC) · Supplement 2AP
2000-11-20Manufacturing (CMC) · Supplement 3AP
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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