FDA — authorised 7 December 2015
- Application: NDA208194
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: BENDEKA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Bendamustine hydrochloride injection in United States
FDA authorised Bendamustine hydrochloride injection on 7 December 2015
Marketing authorisations
FDA — authorised 15 May 2018
- Application: NDA205580
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: BELRAPZO
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2022
- Application: ANDA205574
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 15 December 2022
- Application: NDA216078
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 28 April 2023
- Application: ANDA204104
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA211001
- Marketing authorisation holder: MEITHEAL
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA214739
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA204771
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: POWDER — IV (INFUSION)
- Status: approved
FDA
- Application: NDA215668
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA210410
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BENDAMUSTINE HYDROCHLORIDE
- Indication: SOLUTION — IV (INFUSION)
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Bendamustine hydrochloride injection approved in United States?
Yes. FDA authorised it on 7 December 2015; FDA authorised it on 15 May 2018; FDA authorised it on 7 December 2022.
Who is the marketing authorisation holder for Bendamustine hydrochloride injection in United States?
EAGLE PHARMS holds the US marketing authorisation.