FDA — authorised 5 November 2010
- Application: NDA200678
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: KOMBIGLYZE XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Saxagliptin-Metformin XR in United States
FDA authorised Saxagliptin-Metformin XR on 5 November 2010
Marketing authorisation
Other Diabetes approved in United States
Frequently asked questions
Is Saxagliptin-Metformin XR approved in United States?
Yes. FDA authorised it on 5 November 2010.
Who is the marketing authorisation holder for Saxagliptin-Metformin XR in United States?
ASTRAZENECA AB holds the US marketing authorisation.