APPLICATION
ANDA075074
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-11
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ETODOLACPrescription
ETODOLAC 400MG · TABLET · ORAL
ETODOLACPrescription
ETODOLAC 500MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 33 · standardAP
2021-04-28Labeling · Supplement 26 · standardAP
2016-05-09Labeling · Supplement 18 · standardAP
2009-01-14Labeling · Supplement 13AP
2006-11-17Labeling · Supplement 12AP
2006-03-02Labeling · Supplement 10AP
2002-09-11Manufacturing (CMC) · Supplement 5AP
2002-09-11Manufacturing (CMC) · Supplement 6AP
2002-07-18Manufacturing (CMC) · Supplement 3AP
2002-05-10Manufacturing (CMC) · Supplement 7AP
2000-04-25Manufacturing (CMC) · Supplement 1AP
2000-04-25Labeling · Supplement 2AP
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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