FDA — authorised 2 December 1996
- Application: ANDA074137
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Subutex in United States
FDA authorised Subutex on 2 December 1996
Marketing authorisations
FDA — authorised 22 February 2013
- Application: ANDA090622
- Marketing authorisation holder: ETHYPHARM
- Indication: Labeling
- Status: approved
FDA — authorised 15 June 2020
- Application: ANDA076931
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 4 March 2021
- Application: ANDA090279
- Marketing authorisation holder: RUBICON RESEARCH
- Indication: Labeling
- Status: approved
FDA — authorised 4 March 2021
- Application: NDA204242
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Indication: Labeling
- Status: approved
Subutex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Subutex approved in United States?
Yes. FDA authorised it on 2 December 1996; FDA authorised it on 22 February 2013; FDA authorised it on 15 June 2020.
Who is the marketing authorisation holder for Subutex in United States?
HOSPIRA holds the US marketing authorisation.