FDA — authorised 30 January 1998
- Application: NDA050731
- Marketing authorisation holder: HIKMA
- Local brand name: DAUNORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Daunorubicin Hydrochloride in United States
FDA authorised Daunorubicin Hydrochloride on 30 January 1998
Marketing authorisations
FDA — authorised 23 June 1998
- Application: ANDA064212
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: DAUNORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 May 1999
- Application: ANDA065000
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DAUNORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 January 2000
- Application: ANDA065035
- Marketing authorisation holder: MEITHEAL
- Local brand name: DAUNORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 2001
- Application: ANDA065034
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DAUNORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 2019
- Application: ANDA208759
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: DAUNORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 September 2022
- Application: NDA209401
- Marketing authorisation holder: JAZZ PHARMS THERAP
- Indication: Efficacy
- Status: approved
Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride approved in United States?
Yes. FDA authorised it on 30 January 1998; FDA authorised it on 23 June 1998; FDA authorised it on 25 May 1999.
Who is the marketing authorisation holder for Daunorubicin Hydrochloride in United States?
HIKMA holds the US marketing authorisation.