FDA — authorised 25 June 1962
- Application: NDA012967
- Marketing authorisation holder: BRACCO
- Local brand name: ORAGRAFIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 IPODATE SODIUM in United States
FDA authorised IPODATE SODIUM on 25 June 1962
Marketing authorisations
FDA — authorised 11 August 1982
- Application: ANDA087768
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: BILIVIST
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
IPODATE SODIUM 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 IPODATE SODIUM approved in United States?
Yes. FDA authorised it on 25 June 1962; FDA authorised it on 11 August 1982; FDA has authorised it.
Who is the marketing authorisation holder for IPODATE SODIUM in United States?
BRACCO holds the US marketing authorisation.