← FDA DRUG APPROVALS

FDA NDA · NDA021700

AVANDARYL

Sponsor: SB PHARMCO

APPLICATION
NDA021700
TYPE
NDA
ORIGINAL APPROVAL
2005-11-23
LATEST ACTION
2015-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AVANDARYL · ReferenceDiscontinued
GLIMEPIRIDE 2MG, ROSIGLITAZONE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDARYL · ReferenceDiscontinued
GLIMEPIRIDE 2MG, ROSIGLITAZONE MALEATE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDARYL · ReferenceDiscontinued
GLIMEPIRIDE 4MG, ROSIGLITAZONE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDARYL · ReferenceDiscontinued
GLIMEPIRIDE 4MG, ROSIGLITAZONE MALEATE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDARYL · ReferenceDiscontinued
GLIMEPIRIDE 1MG, ROSIGLITAZONE MALEATE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-12-16REMS · Supplement 22 — Letter ↗AP
2015-03-16Labeling · Supplement 21 · standard — Label ↗AP
2014-05-07REMS · Supplement 18 — Letter ↗AP
2014-05-07REMS · Supplement 20 — Letter ↗AP
2014-05-07Labeling · Supplement 19 · 901 required — Letter ↗AP
2013-09-16REMS · Supplement 16 — Letter ↗AP
2013-01-25REMS · Supplement 15 — Letter ↗AP
2012-05-30REMS · Supplement 13 — Label ↗AP
2011-11-13REMS · Supplement 12 — Letter ↗AP
2011-05-18REMS · Supplement 11 — Letter ↗AP
2011-02-03Labeling · Supplement 10 · standard — Letter ↗AP
2009-11-29Labeling · Supplement 9 · standard — Label ↗AP
2008-12-02Labeling · Supplement 8 · standard — Label ↗AP
2007-09-20Labeling · Supplement 6 · standard — Letter ↗AP
2007-08-21Labeling · Supplement 7 · standard — Label ↗AP
2007-03-30Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2006-10-24Efficacy · Supplement 3 · unknown — Label ↗AP
2006-06-15Labeling · Supplement 4 · standard — Letter ↗AP
2006-06-15Labeling · Supplement 2 · standard — Label ↗AP
2005-11-23Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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