FDA — authorised 10 October 2002
- Application: NDA021410
- Marketing authorisation holder: SB PHARMCO
- Local brand name: AVANDAMET
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Avandamet in United States
FDA authorised Avandamet on 10 October 2002
Marketing authorisations
FDA — authorised 7 May 2014
- Application: ANDA077337
- Marketing authorisation holder: TEVA
- Local brand name: ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Avandamet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Avandamet approved in United States?
Yes. FDA authorised it on 10 October 2002; FDA authorised it on 7 May 2014; FDA has authorised it.
Who is the marketing authorisation holder for Avandamet in United States?
SB PHARMCO holds the US marketing authorisation.