← FDA DRUG APPROVALS

FDA ANDA · ANDA209903

DICLOFENAC SODIUM

Sponsor: CIPLA

APPLICATION
ANDA209903
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-03
LATEST ACTION
2024-07-15
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Over-the-counter

Products

DICLOFENAC SODIUMOver-the-counter
DICLOFENAC SODIUM 1% · GEL · TOPICAL

Approval history

2024-07-15Manufacturing (CMC) · Supplement 10 · unknownReviewAP
2018-08-03UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →