FDA — authorised 16 April 1957
- Application: NDA009519
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: DORIDEN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Glimid in United States
FDA authorised Glimid on 16 April 1957
Marketing authorisations
FDA — authorised 1 April 1977
- Application: ANDA083475
- Marketing authorisation holder: LANNETT
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 1977
- Application: ANDA084362
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 1977
- Application: ANDA085763
- Marketing authorisation holder: WATSON LABS
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1977
- Application: ANDA085571
- Marketing authorisation holder: LANNETT
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 1981
- Application: ANDA087297
- Marketing authorisation holder: VITARINE
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 October 1986
- Application: ANDA089459
- Marketing authorisation holder: HALSEY
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085171
- Marketing authorisation holder: UCB INC
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089458
- Marketing authorisation holder: HALSEY
- Local brand name: GLUTETHIMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Glimid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Glimid approved in United States?
Yes. FDA authorised it on 16 April 1957; FDA authorised it on 1 April 1977; FDA authorised it on 1 August 1977.
Who is the marketing authorisation holder for Glimid in United States?
SANOFI AVENTIS US holds the US marketing authorisation.