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FDA ANDA · ANDA075582

DICLOFENAC POTASSIUM

Sponsor: CHARTWELL RX

APPLICATION
ANDA075582
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-23
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DICLOFENAC POTASSIUMDiscontinued
DICLOFENAC POTASSIUM 50MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 8 · standardAP
2023-11-20Labeling · Supplement 7 · standardAP
2021-04-28Labeling · Supplement 5 · standardAP
2021-03-31Labeling · Supplement 4 · standardAP
2001-02-23OriginalLetterAP
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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