FDA — authorised 3 June 2005
- Application: NDA021748
- Marketing authorisation holder: SANTARUS INC
- Local brand name: GLUMETZA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Glucophage in United States
FDA authorised Glucophage on 3 June 2005
Marketing authorisations
FDA — authorised 28 August 2015
- Application: NDA202270
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Labeling
- Status: approved
FDA — authorised 5 April 2017
- Application: NDA021591
- Marketing authorisation holder: RANBAXY
- Indication: Labeling
- Status: approved
FDA — authorised 11 August 2021
- Application: ANDA213359
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 17 September 2021
- Application: NDA209806
- Marketing authorisation holder: MSD SUB MERCK
- Indication: Efficacy
- Status: approved
FDA — authorised 20 June 2025
- Application: ANDA079009
- Marketing authorisation holder: HERITAGE
- Indication: Labeling
- Status: approved
The FDA approved Glucophage for the treatment of type 2 diabetes mellitus. The approval was granted to HERITAGE on 20 June 2025, following a standard expedited pathway. The application number for this approval is ANDA079009.
Glucophage in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Glucophage approved in United States?
Yes. FDA authorised it on 3 June 2005; FDA authorised it on 28 August 2015; FDA authorised it on 5 April 2017.
Who is the marketing authorisation holder for Glucophage in United States?
SANTARUS INC holds the US marketing authorisation.