FDA — authorised 18 December 1996
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Glyset in United States
FDA authorised Glyset on 18 December 1996
Marketing authorisations
FDA — authorised 24 February 2015
- Application: ANDA203965
- Marketing authorisation holder: ORIENT PHARMA
- Local brand name: MIGLITOL
- Indication: TABLET — ORAL
- Status: approved
Glyset 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 Glyset approved in United States?
Yes. FDA authorised it on 18 December 1996; FDA authorised it on 24 February 2015.
Who is the marketing authorisation holder for Glyset in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.