APPLICATION
ANDA091134
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-23
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ETODOLACPrescription
ETODOLAC 600MG · TABLET, EXTENDED RELEASE · ORAL
ETODOLACPrescription
ETODOLAC 400MG · TABLET, EXTENDED RELEASE · ORAL
ETODOLACPrescription
ETODOLAC 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 10 · standardAP
2021-04-28Labeling · Supplement 8 · standardAP
2021-04-26Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 2 · standardAP
2014-01-23OriginalAP
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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