FDA — authorised 23 August 1993
- Application: NDA020136
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DEMADEX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Demadex in United States
FDA authorised Demadex on 23 August 1993
Marketing authorisations
FDA — authorised 14 May 2002
- Application: ANDA076110
- Marketing authorisation holder: TEVA
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2003
- Application: ANDA076226
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 2007
- Application: ANDA078249
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 June 2008
- Application: ANDA078007
- Marketing authorisation holder: HIKMA
- Local brand name: TORSEMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 January 2009
- Application: ANDA079234
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: TORSEMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2021
- Application: NDA213218
- Marketing authorisation holder: SARFE PHARMS
- Local brand name: SOAANZ
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Demadex approved in United States?
Yes. FDA authorised it on 23 August 1993; FDA authorised it on 14 May 2002; FDA authorised it on 27 May 2003.
Who is the marketing authorisation holder for Demadex in United States?
PHARMOBEDIENT holds the US marketing authorisation.