APPLICATION
ANDA075463
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-26
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
2021-04-28Labeling · Supplement 18 · standardAP
2021-03-31Labeling · Supplement 14 · standardAP
2015-05-14Labeling · Supplement 12 · standardAP
2009-08-21Labeling · Supplement 11AP
2007-10-16Labeling · Supplement 6AP
2006-06-07Labeling · 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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