FDA — authorised 20 March 2008
- Application: NDA022249
- Marketing authorisation holder: CEPHALON
- Local brand name: TREANDA
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Treanda in United States
FDA authorised Treanda on 20 March 2008
Marketing authorisations
FDA — authorised 23 September 2016
- Application: NDA208194
- Marketing authorisation holder: EAGLE PHARMS
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA211001
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA214739
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 8 February 2024
- Application: NDA212209
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
The FDA approved Treanda, a drug product, for labeling on February 8, 2024. This approval was granted to AZURITY through a standard expedited pathway. The application number for this approval is NDA212209.
FDA — authorised 15 April 2024
- Application: NDA215033
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved Treanda, a medication, for its labelled indication on 2024-04-15. The marketing authorisation was granted to APOTEX under the standard expedited pathway. The application number for this approval is NDA215033.
Treanda 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 Treanda approved in United States?
Yes. FDA authorised it on 20 March 2008; FDA authorised it on 23 September 2016; FDA authorised it on 5 June 2023.
Who is the marketing authorisation holder for Treanda in United States?
CEPHALON holds the US marketing authorisation.