APPLICATION
ANDA076152
TYPE
ANDA
ORIGINAL APPROVAL
2001-12-13
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DICLOFENAC SODIUMDiscontinued
DICLOFENAC SODIUM 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-07-16Manufacturing (CMC) · Supplement 19 · unknownAP
2024-11-21Labeling · Supplement 17 · standardAP
2024-09-12Labeling · Supplement 15 · standardAP
2021-04-28Labeling · Supplement 14 · standardAP
2017-01-24Labeling · Supplement 10 · standardAP
2017-01-24Labeling · Supplement 11 · standardAP
2010-01-29Labeling · Supplement 8AP
2007-10-25Labeling · Supplement 3AP
2006-06-15Labeling · Supplement 2AP
2002-06-12Manufacturing (CMC) · Supplement 1AP
2001-12-13OriginalAP
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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