FDA — authorised 14 March 1973
- Application: NDA017116
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADOSE
- Indication: CONCENTRATE — ORAL
- Status: approved
🇺🇸 Methadon in United States
FDA authorised Methadon on 14 March 1973
Marketing authorisations
FDA — authorised 15 April 1993
- Application: ANDA040050
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADOSE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 1993
- Application: ANDA074184
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADOSE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
Other Neuroscience approved in United States
Frequently asked questions
Is Methadon approved in United States?
Yes. FDA authorised it on 14 March 1973; FDA authorised it on 15 April 1993; FDA authorised it on 29 April 1993.
Who is the marketing authorisation holder for Methadon in United States?
SPECGX LLC holds the US marketing authorisation.