FDA — authorised 28 August 1951
- Application: NDA007883
- Marketing authorisation holder: TEVA WOMENS
- Local brand name: ANTABUSE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Antabuse in United States
FDA authorised Antabuse on 28 August 1951
Marketing authorisations
FDA — authorised 28 August 1951
- Status: approved
FDA — authorised 31 March 1981
- Application: ANDA086890
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 1981
- Application: ANDA086889
- Marketing authorisation holder: WATSON LABS
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 1983
- Application: ANDA087973
- Marketing authorisation holder: WATSON LABS
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 1983
- Application: ANDA087974
- Marketing authorisation holder: WATSON LABS
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2011
- Application: ANDA091619
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA091563
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 August 2013
- Application: ANDA091681
- Marketing authorisation holder: ALVOGEN
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2014
- Application: ANDA202652
- Marketing authorisation holder: HIKMA
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2015
- Application: ANDA203916
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: DISULFIRAM
- Indication: TABLET — ORAL
- Status: approved
Antabuse 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 Antabuse approved in United States?
Yes. FDA authorised it on 28 August 1951; FDA authorised it on 28 August 1951; FDA authorised it on 31 March 1981.
Who is the marketing authorisation holder for Antabuse in United States?
TEVA WOMENS holds the US marketing authorisation.