← FDA DRUG APPROVALS

FDA NDA · NDA020254

VOLTAREN-XR

Sponsor: NOVARTIS

APPLICATION
NDA020254
TYPE
NDA
ORIGINAL APPROVAL
1996-03-08
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VOLTAREN-XR · ReferenceDiscontinued
DICLOFENAC SODIUM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-04-28Labeling · Supplement 30 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 28 · standard — Letter ↗AP
2014-06-05Manufacturing (CMC) · Supplement 26 · standardAP
2014-02-28Manufacturing (CMC) · Supplement 25 · standardAP
2013-01-25Manufacturing (CMC) · Supplement 23 · standardAP
2011-02-23Labeling · Supplement 20 · standard — Label ↗AP
2011-02-23Labeling · Supplement 19 · unknown — Letter ↗AP
2009-02-25Labeling · Supplement 18 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 16 · standard — Review ↗AP
2002-09-19Manufacturing (CMC) · Supplement 13 · standardAP
2002-03-11Manufacturing (CMC) · Supplement 12 · standardAP
2001-11-05Manufacturing (CMC) · Supplement 11 · standardAP
2001-10-31Labeling · Supplement 2 · standardAP
2001-09-28Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-13Manufacturing (CMC) · Supplement 8 · standardAP
2000-10-23Manufacturing (CMC) · Supplement 9 · standardAP
2000-09-20Manufacturing (CMC) · Supplement 7 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 6 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 5 · standardAP
1997-05-16Manufacturing (CMC) · Supplement 4 · standardAP
1997-03-11Manufacturing (CMC) · Supplement 3 · standardAP
1996-05-21Manufacturing (CMC) · Supplement 1 · standardAP
1996-03-08Type 3 - New Dosage Form · Original · standardAP
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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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