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FDA NDA · NDA020665

DIOVAN

Sponsor: NOVARTIS

APPLICATION
NDA020665
TYPE
NDA
ORIGINAL APPROVAL
1996-12-23
LATEST ACTION
2017-02-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DIOVANDiscontinued
VALSARTAN 80MG · CAPSULE · ORAL
DIOVANDiscontinued
VALSARTAN 160MG · CAPSULE · ORAL

Approval history

2017-02-03Labeling · Supplement 39 · standard — Label ↗AP
2015-07-27Labeling · Supplement 38 · standard — Label ↗AP
2015-02-16Manufacturing (CMC) · Supplement 36 · standardAP
2014-09-24Labeling · Supplement 37 · standard — Letter ↗AP
2014-03-17Labeling · Supplement 34 · standard — Label ↗AP
2014-03-17Labeling · Supplement 35 · standard — Label ↗AP
2013-10-29Labeling · Supplement 33 · standard — Letter ↗AP
2002-11-06Manufacturing (CMC) · Supplement 18 · standardAP
2002-08-14Efficacy · Supplement 16 · standard — Review ↗AP
2002-08-01Manufacturing (CMC) · Supplement 19 · standardAP
2002-04-29Manufacturing (CMC) · Supplement 17 · standardAP
2001-10-23Manufacturing (CMC) · Supplement 15 · standardAP
2000-11-02Manufacturing (CMC) · Supplement 14 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 12 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 11 · standardAP
2000-04-18Manufacturing (CMC) · Supplement 10 · standardAP
2000-02-23Manufacturing (CMC) · Supplement 9 · standardAP
1999-12-03Manufacturing (CMC) · Supplement 7 · standardAP
1999-11-29Labeling · Supplement 8 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 6 · standardAP
1999-02-18Manufacturing (CMC) · Supplement 5 · standardAP
1998-11-27Labeling · Supplement 4 · standard — Review ↗AP
1998-08-18Manufacturing (CMC) · Supplement 3 · standardAP
1997-08-15Manufacturing (CMC) · Supplement 2 · standardAP
1997-06-27Labeling · Supplement 1 · standardAP
1996-12-23Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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