FDA — authorised 28 August 1981
- Application: ANDA086173
- Marketing authorisation holder: FOSUN PHARMA
- Status: supplemented
🇺🇸 "Metformin" and "Rosuvastatin" seperately in United States
FDA authorised "Metformin" and "Rosuvastatin" seperately on 28 August 1981
Marketing authorisations
FDA — authorised 17 September 2010
- Application: ANDA079025
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 21 December 2011
- Application: ANDA090653
- Marketing authorisation holder: HOSPIRA INC
- Status: approved
FDA — authorised 26 June 2012
- Application: ANDA090979
- Marketing authorisation holder: PADAGIS ISRAEL
- Status: approved
FDA — authorised 12 September 2017
- Application: ANDA206120
- Marketing authorisation holder: XIROMED
- Status: supplemented
Frequently asked questions
Is "Metformin" and "Rosuvastatin" seperately approved in United States?
Yes. FDA authorised it on 28 August 1981; FDA authorised it on 17 September 2010; FDA authorised it on 21 December 2011.
Who is the marketing authorisation holder for "Metformin" and "Rosuvastatin" seperately in United States?
FOSUN PHARMA holds the US marketing authorisation.