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FDA NDA · NDA019201

VOLTAREN

Sponsor: NOVARTIS

APPLICATION
NDA019201
TYPE
NDA
ORIGINAL APPROVAL
1988-07-28
LATEST ACTION
2021-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

VOLTAREN · ReferenceDiscontinued
DICLOFENAC SODIUM 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
VOLTAREN · ReferenceDiscontinued
DICLOFENAC SODIUM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
VOLTAREN · ReferenceDiscontinued
DICLOFENAC SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL

Approval history

2021-04-28Labeling · Supplement 48 · standard — Letter ↗AP
2016-05-09Labeling · Supplement 46 · standard — Letter ↗AP
2014-06-05Manufacturing (CMC) · Supplement 45 · standardAP
2013-01-25Manufacturing (CMC) · Supplement 43 · standardAP
2011-02-23Labeling · Supplement 40 · standard — Letter ↗AP
2011-02-23Labeling · Supplement 39 · unknown — Label ↗AP
2009-02-25Labeling · Supplement 38 · standard — Letter ↗AP
2007-07-09Labeling · Supplement 36 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 35 · standard — Letter ↗AP
2002-11-26Labeling · Supplement 18 · standard — Letter ↗AP
2002-09-19Manufacturing (CMC) · Supplement 33 · standardAP
2002-03-11Manufacturing (CMC) · Supplement 32 · standardAP
2001-10-31Labeling · Supplement 23 · standardAP
2001-09-28Manufacturing (CMC) · Supplement 31 · standardAP
2000-10-23Manufacturing (CMC) · Supplement 30 · standardAP
2000-09-20Manufacturing (CMC) · Supplement 29 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 28 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 27 · standardAP
1999-02-09Manufacturing (CMC) · Supplement 26 · standardAP
1998-04-20Labeling · Supplement 22 · standardAP
1997-05-16Manufacturing (CMC) · Supplement 25 · standardAP
1997-03-11Manufacturing (CMC) · Supplement 24 · standardAP
1995-12-22Manufacturing (CMC) · Supplement 21 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 19 · standardAP
1995-07-28Labeling · Supplement 20 · standardAP
1994-12-08Manufacturing (CMC) · Supplement 17 · standardAP
1993-04-20Manufacturing (CMC) · Supplement 14 · standardAP
1993-01-04Manufacturing (CMC) · Supplement 15 · standardAP
1992-04-21Manufacturing (CMC) · Supplement 13 · standardAP
1991-02-12Manufacturing (CMC) · Supplement 5 · standardAP
1990-02-12Manufacturing (CMC) · Supplement 9 · standardAP
1990-01-24Labeling · Supplement 10AP
1989-09-27Manufacturing (CMC) · Supplement 7 · standardAP
1989-07-20Manufacturing (CMC) · Supplement 1 · standardAP
1989-07-11Manufacturing (CMC) · Supplement 2 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 3 · standardAP
1988-12-30Labeling · Supplement 4AP
1988-07-28Type 1 - New Molecular Entity · Original · standard — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

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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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