FDA
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Indion in United States
Indion (PHENINDIONE) regulatory status in United States.
Marketing authorisations
FDA
- Application: NDA008767
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: HEDULIN
- Indication: TABLET — ORAL
- Status: approved
Indion 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 Indion approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Indion in United States?
SANOFI AVENTIS US holds the US marketing authorisation.