APPLICATION
ANDA074514
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-26
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 50MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 75MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 48 · standardAP
2024-07-11Labeling · Supplement 46 · standardAP
2021-04-28Labeling · Supplement 44 · standardAP
2021-03-31Labeling · Supplement 41 · standardAP
2016-05-09Labeling · Supplement 37 · standardAP
2014-11-07Labeling · Supplement 30AP
2009-05-11Labeling · Supplement 25AP
2008-05-08Labeling · Supplement 23AP
2006-07-28Labeling · Supplement 16AP
2004-07-01Labeling · Supplement 11AP
2004-02-20Labeling · Supplement 9AP
2002-02-21Manufacturing (CMC) · Supplement 7AP
2001-11-02Manufacturing (CMC) · Supplement 6AP
2001-07-13Manufacturing (CMC) · Supplement 5AP
2001-02-16Manufacturing (CMC) · Supplement 4AP
2000-12-04Manufacturing (CMC) · Supplement 3AP
2000-06-02Manufacturing (CMC) · Supplement 2AP
1998-03-12Manufacturing (CMC) · Supplement 1AP
1996-03-26OriginalAP
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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