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FDA NDA · NDA021071

AVANDIA

Sponsor: WOODWARD

APPLICATION
NDA021071
TYPE
NDA
ORIGINAL APPROVAL
1999-05-25
LATEST ACTION
2019-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AVANDIA · ReferenceDiscontinued
ROSIGLITAZONE MALEATE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDIA · ReferenceDiscontinued
ROSIGLITAZONE MALEATE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDIA · ReferenceDiscontinued
ROSIGLITAZONE MALEATE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-02-05Labeling · Supplement 52 · standard — Label ↗AP
2016-09-19Labeling · Supplement 51 · standard — Letter ↗AP
2015-12-16REMS · Supplement 50 — Letter ↗AP
2014-05-07REMS · Supplement 47 — Label ↗AP
2014-05-07Labeling · Supplement 48 · 901 required — Review ↗AP
2014-05-07REMS · Supplement 49 — Label ↗AP
2013-09-16REMS · Supplement 45 — Letter ↗AP
2013-01-25REMS · Supplement 44 — Letter ↗AP
2012-05-30REMS · Supplement 41 — Letter ↗AP
2011-11-13REMS · Supplement 40 — Letter ↗AP
2011-05-18REMS · Supplement 39 — Label ↗AP
2011-02-03Labeling · Supplement 38 · standard — Letter ↗AP
2008-10-20Labeling · Supplement 34 · standard — Label ↗AP
2008-07-10Efficacy · Supplement 26 · unknown — Label ↗AP
2008-02-22Labeling · Supplement 32 · standard — Letter ↗AP
2008-01-16Labeling · Supplement 29 · standard — Letter ↗AP
2007-11-14Labeling · Supplement 31 · standard — Letter ↗AP
2007-09-20Labeling · Supplement 27 · standard — Letter ↗AP
2007-08-14Labeling · Supplement 28 · standard — Letter ↗AP
2007-06-25Labeling · Supplement 24 · standardAP
2007-04-23Labeling · Supplement 23 · standard — Letter ↗AP
2006-06-16Labeling · Supplement 19 · standard — Label ↗AP
2006-06-16Labeling · Supplement 21 · standard — Letter ↗AP
2006-04-21Efficacy · Supplement 16 · unknown — Letter ↗AP
2005-07-29Efficacy · Supplement 15 · priority — Pediatric Medical Review ↗AP
2005-05-12Labeling · Supplement 10 · standard — Letter ↗AP
2005-02-28Efficacy · Supplement 12 · standard — Label ↗AP
2005-01-04Labeling · Supplement 14 · standard — Review ↗AP
2004-05-19Labeling · Supplement 9 · standard — Letter ↗AP
2003-02-27Efficacy · Supplement 4 · standard — Label ↗AP
2002-12-03Labeling · Supplement 8 · standard — Letter ↗AP
2001-02-08Labeling · Supplement 6 · standardAP
2000-12-13Manufacturing (CMC) · Supplement 7 · priorityAP
2000-12-05Labeling · Supplement 5 · standardAP
2000-07-11Labeling · Supplement 2 · standardAP
2000-07-03Manufacturing (CMC) · Supplement 3 · priorityAP
2000-04-03Efficacy · Supplement 1 · standard — Review ↗AP
1999-05-25Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗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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