🇺🇸 Avandia and Amaryl in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Avandia and Amaryl on 1 April 2016

Marketing authorisation

FDA — authorised 1 April 2016

Application: ANDA078709
Marketing authorisation holder: TEVA PHARMS USA
Local brand name: ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
Indication: TABLET — ORAL
Status: approved

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Other Diabetes approved in United States

Frequently asked questions

Is Avandia and Amaryl approved in United States?

Yes. FDA authorised it on 1 April 2016.

Who is the marketing authorisation holder for Avandia and Amaryl in United States?

TEVA PHARMS USA holds the US marketing authorisation.