APPLICATION
ANDA090066
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-01
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 25MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 50MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2024-09-26Labeling · Supplement 14 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2021-03-29Labeling · Supplement 6 · standardAP
2016-05-09Labeling · Supplement 4 · standardAP
2014-10-22Labeling · Supplement 2AP
2014-10-15Manufacturing (CMC) · Supplement 1AP
2010-12-01OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.