← FDA DRUG APPROVALS

FDA NDA · NDA021842

ACTOPLUS MET

pioglitazone and metformin hydrochloride

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021842
TYPE
NDA
ORIGINAL APPROVAL
2005-08-29
LATEST ACTION
2024-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

ACTOPLUS MET · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ACTOPLUS MET · ReferencePrescription
METFORMIN HYDROCHLORIDE 850MG, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL

Approval history

2024-06-28Labeling · Supplement 25 · standard — Label ↗AP
2017-12-21Labeling · Supplement 22 · standard — Label ↗AP
2016-12-12Efficacy · Supplement 20 · standard — Letter ↗AP
2016-12-12Labeling · Supplement 21 · 901 required — Letter ↗AP
2014-08-16Labeling · Supplement 19 · standard — Letter ↗AP
2013-08-15Manufacturing (CMC) · Supplement 18 · standardAP
2012-05-17REMS · Supplement 16 — Letter ↗AP
2012-05-17Efficacy · Supplement 10 · standard — Letter ↗AP
2012-05-17Labeling · Supplement 8 · standard — Label ↗AP
2011-08-04REMS · Supplement 14 — Label ↗AP
2011-08-04Labeling · Supplement 15 · 901 required — Label ↗AP
2010-08-06Labeling · Supplement 12 · standard — Letter ↗AP
2009-10-21REMS · Supplement 11 · unknown — Letter ↗AP
2009-09-14Labeling · Supplement 9 · standard — Letter ↗AP
2009-01-04Labeling · Supplement 7 · standard — Label ↗AP
2007-09-26Labeling · Supplement 5 · standard — Label ↗AP
2006-11-04Labeling · Supplement 2 · standard — Label ↗AP
2006-09-28Labeling · Supplement 3 · standard — Letter ↗AP
2006-08-30Labeling · Supplement 1 · standard — Label ↗AP
2005-08-29Type 4 - New Combination · Original · standard — Label ↗AP
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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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