FDA — authorised 17 January 1991
- Application: NDA019961
- Marketing authorisation holder: CHAPTER 7 TRUSTEE
- Local brand name: GANITE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ganite in United States
FDA authorised Ganite on 17 January 1991
Marketing authorisations
FDA
- Status: approved
Ganite 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 Ganite approved in United States?
Yes. FDA authorised it on 17 January 1991; FDA has authorised it.
Who is the marketing authorisation holder for Ganite in United States?
CHAPTER 7 TRUSTEE holds the US marketing authorisation.