← FDA DRUG APPROVALS

FDA NDA · NDA021410

AVANDAMET

Sponsor: SB PHARMCO

APPLICATION
NDA021410
TYPE
NDA
ORIGINAL APPROVAL
2002-10-10
LATEST ACTION
2017-04-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AVANDAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG, ROSIGLITAZONE MALEATE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG, ROSIGLITAZONE MALEATE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM, ROSIGLITAZONE MALEATE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG, ROSIGLITAZONE MALEATE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AVANDAMET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM, ROSIGLITAZONE MALEATE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2017-04-05Labeling · Supplement 40 · 901 required — Label ↗AP
2015-12-16REMS · Supplement 39 — Letter ↗AP
2014-05-07REMS · Supplement 38 — Label ↗AP
2014-05-07REMS · Supplement 36 — Letter ↗AP
2014-05-07Labeling · Supplement 37 · 901 required — Label ↗AP
2013-09-16REMS · Supplement 34 — Letter ↗AP
2013-06-11Manufacturing (CMC) · Supplement 33 · standardAP
2013-01-25REMS · Supplement 32 — Letter ↗AP
2012-05-30REMS · Supplement 30 — Letter ↗AP
2011-11-13REMS · Supplement 29 — Label ↗AP
2011-05-18REMS · Supplement 27 — Label ↗AP
2011-02-03Labeling · Supplement 26 · standard — Label ↗AP
2008-12-02Labeling · Supplement 25 · standard — Letter ↗AP
2007-09-20Labeling · Supplement 22 · standard — Label ↗AP
2007-08-21Labeling · Supplement 23 · standard — Letter ↗AP
2007-04-23Labeling · Supplement 19 · standard — Letter ↗AP
2007-01-31Efficacy · Supplement 16 · standard — Label ↗AP
2006-05-19Efficacy · Supplement 10 · unknown — Letter ↗AP
2006-04-19Labeling · Supplement 13 · standard — Letter ↗AP
2005-01-04Labeling · Supplement 9 · standard — Review ↗AP
2004-05-19Labeling · Supplement 5 · standard — Label ↗AP
2004-05-19Labeling · Supplement 6 · standard — Letter ↗AP
2003-08-25Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2002-10-10Type 4 - New Combination · 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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