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FDA ANDA · ANDA215787

DICLOFENAC POTASSIUM

diclofenac potassium, film coated

Sponsor: SENORES PHARMS

APPLICATION
ANDA215787
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-15
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 50MG · TABLET · ORAL
DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 25MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 3 · standardAP
2023-11-09Manufacturing (CMC) · Supplement 1 · unknownAP
2023-03-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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