FDA — authorised 20 March 1990
- Application: NDA009386
- Marketing authorisation holder: WAYLIS THERAP
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Busulfex in United States
FDA authorised Busulfex on 20 March 1990
Marketing authorisations
FDA — authorised 19 April 2007
- Application: NDA020954
- Marketing authorisation holder: OTSUKA PHARM
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 December 2015
- Application: ANDA202259
- Marketing authorisation holder: AM REGENT
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 2017
- Application: ANDA207050
- Marketing authorisation holder: PHARMASCIENCE INC
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA205139
- Marketing authorisation holder: ACTAVIS
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 July 2018
- Application: ANDA205184
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 July 2018
- Application: ANDA205672
- Marketing authorisation holder: HOSPIRA
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 September 2018
- Application: ANDA205106
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 2019
- Application: ANDA207794
- Marketing authorisation holder: NEXUS
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA210148
- Marketing authorisation holder: ACCORD HLTHCARE INC
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 2019
- Application: ANDA210448
- Marketing authorisation holder: APOTEX
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 May 2019
- Application: ANDA209580
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
FDA — authorised 23 October 2020
- Application: ANDA212127
- Marketing authorisation holder: MEITHEAL
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 June 2021
- Application: ANDA210931
- Marketing authorisation holder: SHILPA
- Indication: Labeling
- Status: approved
FDA — authorised 25 June 2024
- Application: ANDA215102
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 September 2024
- Application: ANDA215235
- Marketing authorisation holder: PRINSTON INC
- Local brand name: BUSULFAN
- Indication: INJECTABLE — INJECTION
- Status: approved
Busulfex 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 Busulfex approved in United States?
Yes. FDA authorised it on 20 March 1990; FDA authorised it on 19 April 2007; FDA authorised it on 22 December 2015.
Who is the marketing authorisation holder for Busulfex in United States?
WAYLIS THERAP holds the US marketing authorisation.