Actoplus Met Xr

NDA 22024, held by Takeda Pharms USA. Metformin Hydrochloride; Pioglitazone Hydrochloride.

As of Nov 14, 2026, NDA 22024 (Actoplus Met Xr), held by Takeda Pharms USA, was first approved by FDA on May 12, 2009, with 10 approved supplements and 0 published complete response letters.

First approved: May 12, 2009
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Dec 12, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter
May 12, 2009	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Actoplus Met Xr1GM;EQ 15MG BASE · tablet, extended release;oral	Metformin Hydrochloride; Pioglitazone Hydrochloride	DiscontinuedReference drug
Actoplus Met Xr1GM;EQ 30MG BASE · tablet, extended release;oral	Metformin Hydrochloride; Pioglitazone Hydrochloride	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Dec 21, 2017	Supplement 14Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 12, 2016	Supplement 13Labeling	Approved	Label Letter
Dec 12, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter
Mar 16, 2015	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 12, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Sep 27, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
May 17, 2012	Supplement 9REMS	Approved	Letter
Aug 4, 2011	Supplement 8REMS	Approved	Letter Label
Aug 4, 2011	Supplement 7Labeling	Approved	Letter Label
Dec 22, 2010	Supplement 2Labeling	Approved	Letter Label
May 12, 2009	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 22024
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters