APPLICATION
ANDA074432
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-29
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DICLOFENAC SODIUMDiscontinued
DICLOFENAC SODIUM 50MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMDiscontinued
DICLOFENAC SODIUM 75MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2016-05-09Labeling · Supplement 17 · standardAP
2007-01-08Labeling · Supplement 13AP
2006-02-23Labeling · Supplement 9AP
2002-03-25Labeling · Supplement 3AP
2001-06-29Manufacturing (CMC) · Supplement 2AP
2000-07-07Manufacturing (CMC) · Supplement 1AP
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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