FDA — authorised 2 May 1957
- Application: NDA010927
- Marketing authorisation holder: BRACCO
- Local brand name: PHOSPHOTOPE
- Indication: SOLUTION — INJECTION, ORAL
- Status: approved
🇺🇸 Phosphotope in United States
FDA authorised Phosphotope on 2 May 1957
Marketing authorisations
FDA — authorised 4 March 1959
- Marketing authorisation holder: MALLINCKRODT
- Status: approved
Phosphotope in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Phosphotope approved in United States?
Yes. FDA authorised it on 2 May 1957; FDA authorised it on 4 March 1959.
Who is the marketing authorisation holder for Phosphotope in United States?
BRACCO holds the US marketing authorisation.