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FDA ANDA · ANDA075665

ETODOLAC

Sponsor: TEVA

APPLICATION
ANDA075665
TYPE
ANDA
ORIGINAL APPROVAL
2000-07-31
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ETODOLACPrescription
ETODOLAC 500MG · TABLET, EXTENDED RELEASE · ORAL
ETODOLACPrescription
ETODOLAC 400MG · TABLET, EXTENDED RELEASE · ORAL
ETODOLACPrescription
ETODOLAC 600MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 15 · standardAP
2021-04-28Labeling · Supplement 13 · standardAP
2016-05-09Labeling · Supplement 9 · standardAP
2006-08-14Labeling · Supplement 7AP
2006-03-02Labeling · Supplement 6AP
2001-04-19Manufacturing (CMC) · Supplement 4AP
2001-02-05Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2001-02-05Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2001-02-05Labeling · Supplement 2 — Letter ↗AP
2000-07-31Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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