FDA — authorised 29 October 1999
- Application: ANDA065004
- Marketing authorisation holder: HIKMA
- Local brand name: CYCLOSPORINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CYCLOSPORINE in United States
FDA authorised CYCLOSPORINE on 29 October 1999
Marketing authorisations
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 23 December 2002
- Application: NDA050790
- Marketing authorisation holder: ABBVIE
- Local brand name: RESTASIS MULTIDOSE
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 7 October 2003
- Application: ANDA065151
- Marketing authorisation holder: PADAGIS US
- Local brand name: CYCLOSPORINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 September 2004
- Application: ANDA065133
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: CYCLOSPORINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 5 January 2005
- Application: ANDA065167
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CYCLOSPORINE
- Indication: SOLUTION — 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 29 March 2005
- Application: ANDA065110
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — 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 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
- Local brand name: VERKAZIA
- Indication: EMULSION — OPHTHALMIC
- 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 15 September 2025
- Application: ANDA219049
- Marketing authorisation holder: QILU
- Local brand name: CYCLOSPORINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 November 2025
- Application: ANDA211909
- Marketing authorisation holder: AMNEAL
- 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
CYCLOSPORINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CYCLOSPORINE approved in United States?
Yes. FDA authorised it on 29 October 1999; FDA authorised it on 13 January 2000; FDA authorised it on 3 March 2000.
Who is the marketing authorisation holder for CYCLOSPORINE in United States?
HIKMA holds the US marketing authorisation.