APPLICATION
ANDA202769
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-08
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
DICLOFENAC SODIUMDiscontinued
DICLOFENAC SODIUM 1.5% · SOLUTION · TOPICAL
Approval history
2024-11-21Labeling · Supplement 6 · standardAP
2024-11-15Labeling · Supplement 5 · standardAP
2021-04-28Labeling · Supplement 4 · standardAP
2020-06-12Manufacturing (CMC) · Supplement 3AP
2018-08-09Labeling · Supplement 1 · standardAP
2015-07-08UNKNOWN · OriginalAP
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.