APPLICATION
ANDA076201
TYPE
ANDA
ORIGINAL APPROVAL
2002-11-06
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 32 · standardAP
2024-03-01Labeling · Supplement 29 · standardAP
2021-04-28Labeling · Supplement 27 · standardAP
2014-12-14Labeling · Supplement 10AP
2010-07-06Labeling · Supplement 9AP
2009-07-31Labeling · Supplement 8AP
2006-11-29Labeling · Supplement 6AP
2006-03-13Labeling · Supplement 5AP
2003-10-23Labeling · Supplement 3AP
2002-11-06OriginalAP
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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