FDA — authorised 14 November 1983
- Application: NDA050573
- Marketing authorisation holder: NOVARTIS
- Local brand name: SANDIMMUNE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Sandimmune in United States
FDA authorised Sandimmune on 14 November 1983
Marketing authorisations
FDA — authorised 14 November 1983
- Application: NDA050574
- Marketing authorisation holder: NOVARTIS
- Local brand name: SANDIMMUNE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 14 November 1983
- Marketing authorisation holder: NOVARTIS
- Status: approved
FDA — authorised 2 March 1990
- Application: NDA050625
- Marketing authorisation holder: NOVARTIS
- Local brand name: SANDIMMUNE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 October 1999
- Application: ANDA065004
- Marketing authorisation holder: HIKMA
- Local brand name: CYCLOSPORINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 January 2000
- Application: ANDA065017
- Marketing authorisation holder: SANDOZ
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 March 2000
- Application: ANDA065025
- Marketing authorisation holder: ABBVIE
- Local brand name: CYCLOSPORINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 20 December 2000
- Application: ANDA065044
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 December 2001
- Application: ANDA065054
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CYCLOSPORINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 9 May 2002
- Application: ANDA065040
- Marketing authorisation holder: APOTEX
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 March 2005
- Application: ANDA065078
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CYCLOSPORINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 July 2019
- Application: ANDA210721
- Marketing authorisation holder: APOTEX
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 February 2022
- Application: ANDA205894
- Marketing authorisation holder: MYLAN
- Local brand name: CYCLOSPORINE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 2 August 2022
- Application: ANDA216046
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 January 2023
- Application: ANDA207606
- Marketing authorisation holder: APOTEX
- Local brand name: CYCLOSPORINE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 21 May 2024
- Application: ANDA209811
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: CYCLOSPORINE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 21 January 2026
- Application: ANDA209064
- Marketing authorisation holder: TWI PHARMS
- Local brand name: CYCLOSPORINE
- Indication: EMULSION — OPHTHALMIC
- 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 Oncology approved in United States
Frequently asked questions
Is Sandimmune approved in United States?
Yes. FDA authorised it on 14 November 1983; FDA authorised it on 14 November 1983; FDA authorised it on 14 November 1983.
Who is the marketing authorisation holder for Sandimmune in United States?
NOVARTIS holds the US marketing authorisation.