FDA — authorised 16 September 2013
- Application: ANDA201537
- Marketing authorisation holder: DR REDDYS
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
🇺🇸 5-Azacitidine in United States
FDA authorised 5-Azacitidine on 16 September 2013
Marketing authorisations
FDA — authorised 29 April 2016
- Application: NDA208216
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 29 September 2016
- Application: ANDA207518
- Marketing authorisation holder: SHILPA MEDICARE
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 23 June 2017
- Application: ANDA207234
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 2 July 2018
- Application: ANDA207475
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 27 February 2019
- Application: ANDA210748
- Marketing authorisation holder: LUPIN
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 8 June 2020
- Application: ANDA209337
- Marketing authorisation holder: EUROHLTH INTL SARL
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 2 November 2020
- Application: ANDA212128
- Marketing authorisation holder: MEITHEAL
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 15 October 2024
- Application: ANDA215765
- Marketing authorisation holder: HETERO LABS LTD VI
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 20 May 2025
- Application: ANDA217453
- Marketing authorisation holder: RELIANCE LIFE
- Local brand name: AZACITIDINE
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA
- Application: ANDA218751
- Marketing authorisation holder: TEVA PHARMACEUTICALS DEVELOPMENT INC
- Local brand name: AZACITIDINE
- Indication: TABLET
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is 5-Azacitidine approved in United States?
Yes. FDA authorised it on 16 September 2013; FDA authorised it on 29 April 2016; FDA authorised it on 29 September 2016.
Who is the marketing authorisation holder for 5-Azacitidine in United States?
DR REDDYS holds the US marketing authorisation.