FDA — authorised 27 September 2000
- Application: NDA020637
- Marketing authorisation holder: AZURITY
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Gliadel in United States
FDA authorised Gliadel on 27 September 2000
Marketing authorisations
FDA — authorised 13 June 2014
- Application: NDA017422
- Marketing authorisation holder: AVET LIFESCIENCES
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 September 2018
- Application: ANDA210179
- Marketing authorisation holder: NAVINTA LLC
- Status: approved
FDA — authorised 16 October 2018
- Application: ANDA211229
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 12 March 2021
- Application: ANDA211202
- Marketing authorisation holder: HENGRUI PHARMA
- Status: approved
Gliadel 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 Gliadel approved in United States?
Yes. FDA authorised it on 27 September 2000; FDA authorised it on 13 June 2014; FDA authorised it on 11 September 2018.
Who is the marketing authorisation holder for Gliadel in United States?
AZURITY holds the US marketing authorisation.