FDA — authorised 24 December 1987
- Application: NDA019432
- Marketing authorisation holder: IMP
- Local brand name: SPECTAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 IOFETAMINE HYDROCHLORIDE I 123 in United States
FDA authorised IOFETAMINE HYDROCHLORIDE I 123 on 24 December 1987
Marketing authorisations
FDA
- Status: approved
IOFETAMINE HYDROCHLORIDE I 123 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is IOFETAMINE HYDROCHLORIDE I 123 approved in United States?
Yes. FDA authorised it on 24 December 1987; FDA has authorised it.
Who is the marketing authorisation holder for IOFETAMINE HYDROCHLORIDE I 123 in United States?
IMP holds the US marketing authorisation.