APPLICATION
ANDA075281
TYPE
ANDA
ORIGINAL APPROVAL
2002-02-12
LATEST ACTION
2025-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 75MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 50MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2025-12-31Labeling · Supplement 16 · standardAP
2024-11-21Labeling · Supplement 14 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2021-03-29Labeling · Supplement 9 · standardAP
2016-05-09Labeling · Supplement 8 · standardAP
2014-11-28Labeling · Supplement 7 · standardAP
2010-03-19Labeling · Supplement 3AP
2007-12-20Labeling · Supplement 1AP
2002-02-12OriginalAP
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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