← FDA DRUG APPROVALS

FDA ANDA · ANDA205878

DICLOFENAC SODIUM

Sponsor: NOVEL LABS INC

APPLICATION
ANDA205878
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-09
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 1.5% · SOLUTION · TOPICAL

Approval history

2024-11-21Labeling · Supplement 3 · standardAP
2021-04-28Labeling · Supplement 2 · standardAP
2020-02-14Labeling · Supplement 1 · standardAP
2015-12-09UNKNOWN · Original · standardReviewAP
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 →