FDA — authorised 30 March 2012
- Application: ANDA040843
- Marketing authorisation holder: PHARMACHEMIE BV
- Indication: Labeling
- Status: approved
🇺🇸 Trexall in United States
FDA authorised Trexall on 30 March 2012
Marketing authorisations
FDA — authorised 15 March 2018
- Application: NDA208400
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
FDA — authorised 11 March 2020
- Application: NDA205776
- Marketing authorisation holder: MEDEXUS
- Indication: Labeling
- Status: approved
FDA — authorised 8 November 2021
- Application: ANDA213343
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 3 June 2024
- Application: ANDA217552
- Marketing authorisation holder: ALEMBIC
- Status: approved
Trexall in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Trexall approved in United States?
Yes. FDA authorised it on 30 March 2012; FDA authorised it on 15 March 2018; FDA authorised it on 11 March 2020.
Who is the marketing authorisation holder for Trexall in United States?
PHARMACHEMIE BV holds the US marketing authorisation.