APPLICATION
ANDA075219
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-06
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 50MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 22 · standardAP
2024-09-26Labeling · Supplement 20 · standardAP
2021-04-28Labeling · Supplement 19 · standardAP
2021-04-01Labeling · Supplement 14 · standardAP
2014-12-05Labeling · Supplement 13AP
2009-05-21Labeling · Supplement 12AP
2006-05-19Labeling · Supplement 10AP
2006-03-13Labeling · Supplement 9AP
2002-08-22Labeling · Supplement 7AP
2000-02-01Manufacturing (CMC) · Supplement 5AP
2000-02-01Manufacturing (CMC) · Supplement 6AP
1999-12-02Manufacturing (CMC) · Supplement 3AP
1999-12-02Manufacturing (CMC) · Supplement 4AP
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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