FDA — authorised 29 July 1948
- Application: NDA006525
- Marketing authorisation holder: ROCHE
- Local brand name: GANTRISIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Gantrisin in United States
FDA authorised Gantrisin on 29 July 1948
Marketing authorisations
FDA — authorised 4 December 1953
- Application: NDA009182
- Marketing authorisation holder: ROCHE
- Local brand name: LIPO GANTRISIN
- Indication: EMULSION — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA006917
- Marketing authorisation holder: ROCHE
- Local brand name: GANTRISIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA007757
- Marketing authorisation holder: ROCHE
- Local brand name: GANTRISIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: NDA008414
- Marketing authorisation holder: ROCHE
- Local brand name: GANTRISIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
Gantrisin 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 Gantrisin approved in United States?
Yes. FDA authorised it on 29 July 1948; FDA authorised it on 4 December 1953; FDA has authorised it.
Who is the marketing authorisation holder for Gantrisin in United States?
ROCHE holds the US marketing authorisation.