APPLICATION
ANDA206493
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-02
LATEST ACTION
2025-05-21
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 3% · GEL · TOPICAL
Approval history
2025-05-21Labeling · Supplement 9 · standardAP
2024-11-21Labeling · Supplement 8 · standardAP
2024-11-14Labeling · Supplement 7 · standardAP
2024-11-14Labeling · Supplement 5 · standardAP
2024-11-14Labeling · Supplement 3 · 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.