Orange Book product · Generic (ANDA)
CYCLOSPORINE
CYCLOSPORINE
At a glance
Sep 15, 2025
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2025
9 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOSPORINE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB1
Application
ANDA 219049
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CYCLOSPORINE
- 2023VEVYEBrand (NDA)
NDA 217469 · HARROW EYE
- 2021VERKAZIABrand (NDA)
NDA 214965 · HARROW EYE
- 2018CEQUABrand (NDA)
NDA 210913 · SUN PHARM
- 2002RESTASISBrand (NDA)
NDA 050790 · ABBVIE
- 1995NEORALBrand (NDA)
NDA 050715 · NOVARTIS
- 1995NEORALBrand (NDA)
NDA 050716 · NOVARTIS
- 1990SANDIMMUNEBrand (NDA)
NDA 050625 · NOVARTIS
- 1983SANDIMMUNEBrand (NDA)
NDA 050573 · NOVARTIS
- 1983SANDIMMUNEBrand (NDA)
NDA 050574 · NOVARTIS
- 2026CYCLOSPORINEGeneric (ANDA)
ANDA 219288 · JIANGSU ANBISON
- 2026CYCLOSPORINEGeneric (ANDA)
ANDA 209064 · TWI PHARMS
- 2025CYCLOSPORINEGeneric (ANDA)
ANDA 211909 · AMNEAL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
