FDA — authorised 27 August 1999
- Application: ANDA075371
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
🇺🇸 Dtic-Dome in United States
FDA authorised Dtic-Dome on 27 August 1999
Marketing authorisations
FDA — authorised 22 September 2000
- Application: ANDA075259
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
FDA — authorised 31 October 2002
- Application: ANDA075812
- Marketing authorisation holder: HIKMA
- Indication: Manufacturing (CMC)
- Status: approved
Dtic-Dome 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 Dtic-Dome approved in United States?
Yes. FDA authorised it on 27 August 1999; FDA authorised it on 22 September 2000; FDA authorised it on 31 October 2002.
Who is the marketing authorisation holder for Dtic-Dome in United States?
FRESENIUS KABI USA holds the US marketing authorisation.