FDA — authorised 29 December 1989
- Application: NDA018511
- Marketing authorisation holder: JUBILANT
- Local brand name: DRAXIMAGE DTPA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Detapac in United States
FDA authorised Detapac on 29 December 1989
Marketing authorisations
FDA — authorised 26 March 2025
- Application: ANDA215146
- Marketing authorisation holder: CURIUM
- Local brand name: TECHNETIUM TC-99M PENTETATE KIT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Detapac in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Detapac approved in United States?
Yes. FDA authorised it on 29 December 1989; FDA authorised it on 26 March 2025; FDA has authorised it.
Who is the marketing authorisation holder for Detapac in United States?
JUBILANT holds the US marketing authorisation.