Drug application

ACTOPLUS MET (METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE)

Drugs@FDA NDA 021842 · TAKEDA PHARMS USA

Key facts

Drug name ACTOPLUS MET
Active ingredients METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
Application type NDA
Application number 021842
Company TAKEDA PHARMS USA
Dosage forms TABLET, ORAL
Strength 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 4 - New Combination
Latest submission status date Aug 29, 2005

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

Browse all Drugs@FDA applications