Orange Book product · Brand (NDA)

ACTOPLUS MET XR

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Brand (NDA)NDA 022024DISCN TAKEDA PHARMS USA

May 12, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 12, 2009
17 yr 4 mo ago
Today
Patent 7785627 expires
Listed drug product patent expiration.
Jul 31, 2026
in 1 mo
Patent 7959946 expires
Listed drug product patent expiration.
Jul 31, 2026
in 1 mo

Active ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Strength

1GM;EQ 15MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022024

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7785627	Jul 31, 2026	in 1 mo	Product
7959946	Jul 31, 2026	in 1 mo	Product