APPLICATION
ANDA075229
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-20
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 50MG · TABLET · ORAL
DICLOFENAC POTASSIUMPrescription
DICLOFENAC POTASSIUM 25MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 35 · standardAP
2021-04-28Labeling · Supplement 23 · standardAP
2021-04-26Labeling · Supplement 20 · standardAP
2014-12-06Labeling · Supplement 16AP
2009-09-04Labeling · Supplement 14AP
2008-04-29Labeling · Supplement 12AP
2006-10-05Labeling · Supplement 11AP
2002-10-02Manufacturing (CMC) · Supplement 4AP
2002-10-02Manufacturing (CMC) · Supplement 5AP
2002-10-02Manufacturing (CMC) · Supplement 3AP
2002-09-10Labeling · Supplement 6AP
2002-03-18Manufacturing (CMC) · Supplement 2AP
2002-03-18Manufacturing (CMC) · Supplement 1AP
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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