← FDA DRUG APPROVALS

FDA NDA · NDA021283

DIOVAN

valsartan

Sponsor: NOVARTIS

APPLICATION
NDA021283
TYPE
NDA
ORIGINAL APPROVAL
2001-07-18
LATEST ACTION
2025-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DIOVAN · ReferencePrescription
VALSARTAN 320MG · TABLET · ORAL
DIOVAN · ReferencePrescription
VALSARTAN 80MG · TABLET · ORAL
DIOVAN · ReferencePrescription
VALSARTAN 40MG · TABLET · ORAL
DIOVAN · ReferencePrescription
VALSARTAN 160MG · TABLET · ORAL

Approval history

2025-07-21Manufacturing (CMC) · Supplement 62 — Letter ↗AP
2021-07-22Manufacturing (CMC) · Supplement 59 — Letter ↗AP
2021-04-19Efficacy · Supplement 58 · standard — Label ↗AP
2019-06-12Labeling · Supplement 53 · standard — Letter ↗AP
2017-02-03Labeling · Supplement 50 · standard — Label ↗AP
2015-07-31Manufacturing (CMC) · Supplement 47 · standardAP
2015-07-27Labeling · Supplement 46 · standard — Letter ↗AP
2014-09-26Labeling · Supplement 44 · standard — Label ↗AP
2014-03-17Labeling · Supplement 42 · standard — Letter ↗AP
2014-03-17Labeling · Supplement 41 · standard — Label ↗AP
2013-10-18Manufacturing (CMC) · Supplement 40 · standardAP
2012-10-04Labeling · Supplement 39 · unknown — Letter ↗AP
2012-07-26Labeling · Supplement 37 · unknown — Label ↗AP
2012-02-28Labeling · Supplement 35 · unknown — Letter ↗AP
2012-01-18Labeling · Supplement 36 · unknown — Letter ↗AP
2011-12-12Labeling · Supplement 33 · unknown — Letter ↗AP
2011-06-03Labeling · Supplement 32 · unknown — Letter ↗AP
2009-06-15Labeling · Supplement 27 · standard — Letter ↗AP
2007-11-29Efficacy · Supplement 24 · priority — Label ↗AP
2007-08-17Labeling · Supplement 21 · standard — Review ↗AP
2006-11-22Labeling · Supplement 18 · standard — Label ↗AP
2005-08-03Efficacy · Supplement 11 · standard — Review ↗AP
2004-11-30Labeling · Supplement 12 · standard — Label ↗AP
2002-11-06Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2002-09-13Manufacturing (CMC) · Supplement 5 · standardAP
2002-08-14Efficacy · Supplement 1 · standard — Review ↗AP
2002-08-01Manufacturing (CMC) · Supplement 6 · standardAP
2002-04-29Manufacturing (CMC) · Supplement 3 · standardAP
2002-04-05Efficacy · Supplement 2 · standard — Label ↗AP
2001-07-18Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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