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FDA ANDA · ANDA074459

DICLOFENAC SODIUM

Sponsor: TEVA PHARMS

APPLICATION
ANDA074459
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-25
LATEST ACTION
1999-03-23
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

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

Approval history

1999-03-23Manufacturing (CMC) · Supplement 1AP
1997-06-25OriginalAP
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Related on SPEQ

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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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