FDA — authorised 21 January 1987
- Marketing authorisation holder: BRACCO
- Status: approved
🇺🇸 Choletec in United States
FDA authorised Choletec on 21 January 1987
Marketing authorisations
FDA — authorised 29 January 2008
- Application: ANDA078242
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: TECHNETIUM TC-99M MEBROFENIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Choletec in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in United States
Frequently asked questions
Is Choletec approved in United States?
Yes. FDA authorised it on 21 January 1987; FDA authorised it on 29 January 2008.
Who is the marketing authorisation holder for Choletec in United States?
BRACCO holds the US marketing authorisation.