FDA — authorised 18 January 2012
- Application: ANDA201991
- Marketing authorisation holder: INVENTIA
- Status: approved
🇺🇸 METFORMIN HYDROCHLORIDE in United States
FDA authorised METFORMIN HYDROCHLORIDE on 18 January 2012 · 33,009 US adverse-event reports
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 14 January 2021
- Application: ANDA213344
- Marketing authorisation holder: GRANULES
- Status: supplemented
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 22 February 2022
- Application: ANDA214629
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: approved
FDA — authorised 14 April 2025
- Application: ANDA219151
- Marketing authorisation holder: BIONPHARMA
- Status: approved
FDA — authorised 20 June 2025
- Application: ANDA079009
- Marketing authorisation holder: HERITAGE
- Indication: Labeling
- Status: approved
The FDA approved METFORMIN HYDROCHLORIDE, manufactured by HERITAGE, on 20 June 2025. This approval was granted under the standard expedited pathway. The drug is indicated for use in accordance with its labelling.
FDA — authorised 3 November 2025
- Application: ANDA208459
- Marketing authorisation holder: MSN
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 33,009
Most-reported reactions
- Lactic Acidosis — 4,734 reports (14.34%)
- Diarrhoea — 4,526 reports (13.71%)
- Nausea — 3,882 reports (11.76%)
- Acute Kidney Injury — 3,339 reports (10.12%)
- Fatigue — 3,214 reports (9.74%)
- Drug Ineffective — 3,010 reports (9.12%)
- Vomiting — 2,825 reports (8.56%)
- Dyspnoea — 2,715 reports (8.23%)
- Blood Glucose Increased — 2,446 reports (7.41%)
- Off Label Use — 2,318 reports (7.02%)
METFORMIN HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is METFORMIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 18 January 2012; FDA authorised it on 28 August 2015; FDA authorised it on 5 April 2017.
Who is the marketing authorisation holder for METFORMIN HYDROCHLORIDE in United States?
INVENTIA holds the US marketing authorisation.