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FDA ANDA · ANDA075185
DICLOFENAC SODIUM DELAYED RELEASE
diclofenac sodium
Sponsor: CARLSBAD
APPLICATION
ANDA075185
TYPE
ANDA
ORIGINAL APPROVAL
1998-11-13
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 50MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 75MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUMPrescription
DICLOFENAC SODIUM 25MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 20 · standardAP
2021-04-29Labeling · Supplement 16 · standardAP
2021-04-29Labeling · Supplement 15 · standardAP
2021-04-20Labeling · Supplement 13 · standardAP
2016-05-09Labeling · Supplement 12 · standardAP
2015-08-24Labeling · Supplement 11AP
2010-02-18Labeling · Supplement 8AP
2006-02-23Labeling · Supplement 5AP
2003-11-19Labeling · Supplement 3AP
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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