← FDA DRUG APPROVALS

FDA NDA · NDA020905

ARAVA

leflunomide

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA020905
TYPE
NDA
ORIGINAL APPROVAL
1998-09-10
LATEST ACTION
2024-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ARAVA · ReferencePrescription
LEFLUNOMIDE 20MG · TABLET · ORAL
ARAVA · ReferenceDiscontinued
LEFLUNOMIDE 100MG · TABLET · ORAL
ARAVA · ReferencePrescription
LEFLUNOMIDE 10MG · TABLET · ORAL

Approval history

2024-06-28Labeling · Supplement 33 · standard — Label ↗AP
2016-10-18Labeling · Supplement 31 · standard — Letter ↗AP
2015-08-28Labeling · Supplement 27 · standard — Label ↗AP
2015-04-29Manufacturing (CMC) · Supplement 26 · priorityAP
2014-11-14Labeling · Supplement 28 · standard — Letter ↗AP
2012-11-02Labeling · Supplement 25 · standard — Label ↗AP
2011-07-08Labeling · Supplement 22 · standard — Letter ↗AP
2010-09-09Labeling · Supplement 20 · 901 required — Letter ↗AP
2009-04-03Labeling · Supplement 18 · standard — Letter ↗AP
2007-11-08Labeling · Supplement 16 · standard — Letter ↗AP
2005-10-19Labeling · Supplement 15 · standard — Letter ↗AP
2004-11-22Labeling · Supplement 14 · standard — Letter ↗AP
2004-03-05Efficacy · Supplement 12 · priority — Review ↗AP
2003-06-13Labeling · Supplement 7 · standard — Review ↗AP
2003-06-13Efficacy · Supplement 6 · priority — Label ↗AP
2000-09-21Manufacturing (CMC) · Supplement 5 · priorityAP
2000-02-23Labeling · Supplement 3 · standardAP
2000-02-23Labeling · Supplement 4 · standardAP
1999-07-20Manufacturing (CMC) · Supplement 2 · priorityAP
1998-12-11Manufacturing (CMC) · Supplement 1 · priorityAP
1998-09-10Type 1 - New Molecular Entity · Original · priority — Pediatric Written Request ↗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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