FDA — authorised 17 June 1969
- Application: NDA016793
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cytarabine in United States
FDA authorised Cytarabine on 17 June 1969
Marketing authorisations
FDA — authorised 2 August 1989
- Application: ANDA071472
- Marketing authorisation holder: HIKMA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 1989
- Application: ANDA071471
- Marketing authorisation holder: HIKMA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA072168
- Marketing authorisation holder: HOSPIRA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 2000
- Application: ANDA075383
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 January 2004
- Application: ANDA076512
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2011
- Application: ANDA200914
- Marketing authorisation holder: RISING
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2011
- Application: ANDA200915
- Marketing authorisation holder: RISING
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2011
- Application: ANDA200916
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 2012
- Application: ANDA201784
- Marketing authorisation holder: RISING
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 2018
- Application: ANDA205696
- Marketing authorisation holder: MEITHEAL
- Local brand name: CYTARABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA211937
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 10 November 2020
- Application: ANDA211938
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 28 February 2022
- Application: ANDA208485
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA
- Application: ANDA071249
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: CYTARABINE
- Indication: Injectable — Injection
- Status: approved
Cytarabine 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 Cytarabine approved in United States?
Yes. FDA authorised it on 17 June 1969; FDA authorised it on 2 August 1989; FDA authorised it on 2 August 1989.
Who is the marketing authorisation holder for Cytarabine in United States?
TEVA PARENTERAL holds the US marketing authorisation.