APPLICATION
ANDA076561
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-18
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CATAFLAMPrescription
DICLOFENAC POTASSIUM 50MG · TABLET · ORAL
CATAFLAMPrescription
DICLOFENAC POTASSIUM 25MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2021-05-17Labeling · Supplement 10 · standardAP
2021-05-17Labeling · Supplement 9 · standardAP
2021-05-17Labeling · Supplement 13 · standardAP
2021-04-29Labeling · Supplement 12 · standardAP
2021-04-12Manufacturing (CMC) · Supplement 11 · unknownAP
2014-12-14Labeling · Supplement 8 · standardAP
2010-05-12Labeling · Supplement 7AP
2009-02-25Labeling · Supplement 6AP
2006-03-17Labeling · Supplement 2AP
2004-03-18OriginalAP
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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