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FDA ANDA · ANDA219945

DICLOFENAC SODIUM

Sponsor: UMEDICA

APPLICATION
ANDA219945
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-05
LATEST ACTION
2025-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 50MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 75MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 25MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2025-11-05UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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