FDA — authorised 21 July 1976
- Marketing authorisation holder: BRACCO
- Status: approved
🇺🇸 Sincalide in United States
FDA authorised Sincalide on 21 July 1976
Marketing authorisations
FDA — authorised 15 July 1985
- Application: NDA017697
- Marketing authorisation holder: BRACCO
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 October 2023
- Application: NDA210850
- Marketing authorisation holder: MAIA PHARMS INC
- Indication: Labeling
- Status: approved
Sincalide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Sincalide approved in United States?
Yes. FDA authorised it on 21 July 1976; FDA authorised it on 15 July 1985; FDA authorised it on 17 October 2023.
Who is the marketing authorisation holder for Sincalide in United States?
BRACCO holds the US marketing authorisation.