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FDA NDA · NDA022024

ACTOPLUS MET XR

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022024
TYPE
NDA
ORIGINAL APPROVAL
2009-05-12
LATEST ACTION
2017-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ACTOPLUS MET XR · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM, PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE · TABLET, EXTENDED RELEASE · ORAL
ACTOPLUS MET XR · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 1GM, PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-12-21Labeling · Supplement 14 · standard — Label ↗AP
2016-12-12Labeling · Supplement 13 · 901 required — Letter ↗AP
2016-12-12Efficacy · Supplement 12 · standard — Letter ↗AP
2015-03-16Manufacturing (CMC) · Supplement 11 · standardAP
2013-11-12Labeling · Supplement 1 · standard — Letter ↗AP
2013-09-27Manufacturing (CMC) · Supplement 10 · standardAP
2012-05-17REMS · Supplement 9 — Letter ↗AP
2011-08-04REMS · Supplement 8 — Letter ↗AP
2011-08-04Labeling · Supplement 7 · 901 required — Label ↗AP
2010-12-22Labeling · Supplement 2 · unknown — Letter ↗AP
2009-05-12Type 3 - New Dosage Form · Original · standard — Label ↗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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