APPLICATION
ANDA075492
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-11
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 16 · standardAP
2021-04-29Labeling · Supplement 14 · standardAP
2021-03-26Labeling · Supplement 13 · standardAP
2010-07-30Labeling · Supplement 6AP
2007-01-08Labeling · Supplement 5AP
2001-12-14Manufacturing (CMC) · Supplement 3AP
2001-06-08Manufacturing (CMC) · Supplement 2AP
2001-06-08Manufacturing (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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