FDA — authorised 28 October 2005
- Application: NDA021877
- Marketing authorisation holder: SANDOZ
- Local brand name: ARRANON
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Arranon in United States
FDA authorised Arranon on 28 October 2005
Marketing authorisations
FDA — authorised 28 October 2005
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
FDA — authorised 17 November 2021
- Application: ANDA215037
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 December 2022
- Application: ANDA216934
- Marketing authorisation holder: DR REDDYS
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 January 2023
- Application: ANDA216038
- Marketing authorisation holder: MEITHEAL
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 3 March 2023
- Application: ANDA214809
- Marketing authorisation holder: SHORLA
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 4 April 2023
- Application: ANDA216346
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 3 January 2024
- Application: ANDA212605
- Marketing authorisation holder: GLAND
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 1 August 2024
- Application: ANDA218554
- Marketing authorisation holder: ALEMBIC
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 5 September 2024
- Application: ANDA216510
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 13 September 2024
- Application: ANDA216948
- Marketing authorisation holder: MSN
- Local brand name: NELARABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Arranon 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 Arranon approved in United States?
Yes. FDA authorised it on 28 October 2005; FDA authorised it on 28 October 2005; FDA authorised it on 17 November 2021.
Who is the marketing authorisation holder for Arranon in United States?
SANDOZ holds the US marketing authorisation.