Actoplus Met

For type 2 diabetes mellitus. NDA 21842, held by Takeda Pharms USA. Metformin Hydrochloride; Pioglitazone Hydrochloride.

As of Nov 14, 2026, NDA 21842 (Actoplus Met), held by Takeda Pharms USA, was first approved by FDA on Aug 29, 2005, with 20 approved supplements and 0 published complete response letters.

First approved: Aug 29, 2005
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ACTOPLUS MET is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Dec 12, 2016	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 17, 2012	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 29, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Patient Package Insert Label

Products

2 strengths and forms


Actoplus Met500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metformin Hydrochloride; Pioglitazone Hydrochloride	DiscontinuedReference drug
Actoplus Met850MG;EQ 15MG BASE · tablet;oral	Metformin Hydrochloride; Pioglitazone Hydrochloride	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 27Labeling	Approved	Label Medication Guide Letter
Jun 28, 2024	Supplement 25Labeling · Standard review	Approved	Label
Dec 21, 2017	Supplement 22Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 12, 2016	Supplement 21Labeling	Approved	Label Letter
Dec 12, 2016	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 16, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Aug 15, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
May 17, 2012	Supplement 16REMS	Approved	Letter
May 17, 2012	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 17, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Aug 4, 2011	Supplement 15Labeling	Approved	Label Letter
Aug 4, 2011	Supplement 14REMS	Approved	Letter Label
Aug 6, 2010	Supplement 12Labeling · Standard review	Approved	Letter
Oct 21, 2009	Supplement 11REMS	Approved	Letter Label
Sep 14, 2009	Supplement 9Labeling · Standard review	Approved	Letter
Jan 4, 2009	Supplement 7Labeling · Standard review	Approved	Label Letter
Sep 26, 2007	Supplement 5Labeling · Standard review	Approved	Letter Label
Nov 4, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Sep 28, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Aug 30, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Aug 29, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Patient Package Insert Label

Identifiers

Application: NDA 21842
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