APPLICATION
ANDA204306
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-06
LATEST ACTION
2023-05-10
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter
Products
DICLOFENAC SODIUMOver-the-counter
DICLOFENAC SODIUM 1% · GEL · TOPICAL
Approval history
2023-05-10Manufacturing (CMC) · Supplement 6AP
2020-08-06Manufacturing (CMC) · Supplement 1AP
2019-05-06UNKNOWN · 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.