FDA — authorised 1 May 2002
- Application: ANDA065036
- Marketing authorisation holder: MEITHEAL
- Local brand name: IDARUBICIN HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Idamycin Pfs in United States
FDA authorised Idamycin Pfs on 1 May 2002
Marketing authorisations
FDA — authorised 1 May 2002
- Application: ANDA065037
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: IDARUBICIN HYDROCHLORIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 14 December 2006
- Application: ANDA065275
- Marketing authorisation holder: HIKMA
- Local brand name: IDARUBICIN HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 May 2007
- Application: ANDA065288
- Marketing authorisation holder: HIKMA
- Local brand name: IDARUBICIN HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 October 2012
- Application: ANDA200144
- Marketing authorisation holder: RISING
- Local brand name: IDARUBICIN HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Idamycin Pfs 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 Idamycin Pfs approved in United States?
Yes. FDA authorised it on 1 May 2002; FDA authorised it on 1 May 2002; FDA authorised it on 14 December 2006.
Who is the marketing authorisation holder for Idamycin Pfs in United States?
MEITHEAL holds the US marketing authorisation.