FDA — authorised 10 November 2020
- Application: ANDA204607
- Marketing authorisation holder: PHARMASCIENCE INC
- Indication: Labeling
- Status: approved
🇺🇸 Dacogen in United States
FDA authorised Dacogen on 10 November 2020
Marketing authorisations
FDA — authorised 2 July 2021
- Application: ANDA212959
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 20 September 2021
- Application: ANDA214569
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 29 September 2021
- Application: ANDA203475
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 24 March 2022
- Application: NDA212576
- Marketing authorisation holder: TAIHO ONCOLOGY
- Indication: Labeling
- Status: approved
Dacogen 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 Dacogen approved in United States?
Yes. FDA authorised it on 10 November 2020; FDA authorised it on 2 July 2021; FDA authorised it on 20 September 2021.
Who is the marketing authorisation holder for Dacogen in United States?
PHARMASCIENCE INC holds the US marketing authorisation.