FDA — authorised 2 May 2006
- Application: NDA021790
- Marketing authorisation holder: OTSUKA
- Local brand name: DACOGEN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Dacogen in United States
FDA authorised Dacogen on 2 May 2006
Marketing authorisations
FDA — authorised 23 January 2014
- Application: NDA205582
- Marketing authorisation holder: SUN PHARM
- Local brand name: DECITABINE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 28 August 2014
- Application: ANDA202969
- Marketing authorisation holder: SANDOZ
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 September 2017
- Application: ANDA206033
- Marketing authorisation holder: CHEMI SPA
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA208601
- Marketing authorisation holder: CIPLA
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 March 2018
- Application: ANDA207100
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 November 2018
- Application: ANDA210756
- Marketing authorisation holder: LUPIN
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 April 2019
- Application: ANDA209056
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 September 2019
- Application: ANDA210984
- Marketing authorisation holder: NOVAST LABS
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 November 2020
- Application: ANDA205539
- Marketing authorisation holder: GLAND
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 December 2020
- Application: ANDA212117
- Marketing authorisation holder: NIVAGEN PHARMS INC
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 12 April 2021
- Application: ANDA212826
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 November 2021
- Application: ANDA214486
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 15 April 2022
- Application: ANDA213472
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA215355
- Marketing authorisation holder: HETERO LABS LTD VI
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 December 2025
- Application: ANDA217814
- Marketing authorisation holder: RELIANCE LIFE SCI
- Local brand name: DECITABINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Dacogen approved in United States?
Yes. FDA authorised it on 2 May 2006; FDA authorised it on 23 January 2014; FDA authorised it on 28 August 2014.
Who is the marketing authorisation holder for Dacogen in United States?
OTSUKA holds the US marketing authorisation.