FDA — authorised 17 January 1964
- Application: NDA014691
- Marketing authorisation holder: APOTEX
- Local brand name: ALKERAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 alkeran in United States
FDA authorised alkeran on 17 January 1964
Marketing authorisations
FDA — authorised 18 November 1992
- Application: NDA020207
- Marketing authorisation holder: APOTEX
- Local brand name: ALKERAN
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is alkeran approved in United States?
Yes. FDA authorised it on 17 January 1964; FDA authorised it on 18 November 1992.
Who is the marketing authorisation holder for alkeran in United States?
APOTEX holds the US marketing authorisation.