APPLICATION
ANDA204648
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-23
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 25MG · CAPSULE · ORAL
Approval history
2025-04-23Labeling · Supplement 10 · standardAP
2025-04-23Labeling · Supplement 5 · standardAP
2020-03-02Labeling · Supplement 1 · standardAP
2016-02-23UNKNOWN · Original · standardAP
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.