FDA — authorised 14 July 1995
- Application: NDA050716
- Marketing authorisation holder: NOVARTIS
- Local brand name: NEORAL
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Sandimmune in United States
FDA authorised Sandimmune on 14 July 1995
Marketing authorisations
FDA — authorised 14 July 1995
- Application: NDA050715
- Marketing authorisation holder: NOVARTIS
- Local brand name: NEORAL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 May 2000
- Application: ANDA065003
- Marketing authorisation holder: ABBVIE
- Local brand name: GENGRAF
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 October 2003
- Application: NDA050790
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 October 2003
- Application: NDA021023
- Marketing authorisation holder: ALLERGAN
- Local brand name: RESTASIS
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 20 September 2019
- Application: NDA210913
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 23 June 2021
- Application: NDA214965
- Marketing authorisation holder: HARROW EYE
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 21 May 2024
- Application: ANDA209811
- Marketing authorisation holder: DEVA HOLDING AS
- Status: approved
FDA — authorised 28 November 2025
- Application: ANDA211909
- Marketing authorisation holder: AMNEAL
- Status: approved
Sandimmune in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Sandimmune approved in United States?
Yes. FDA authorised it on 14 July 1995; FDA authorised it on 14 July 1995; FDA authorised it on 12 May 2000.
Who is the marketing authorisation holder for Sandimmune in United States?
NOVARTIS holds the US marketing authorisation.