Orange Book product · Generic (ANDA)
CYCLOSPORINE
CYCLOSPORINE
At a glance
Dec 14, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 2023
2 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOSPORINE
Strength
0.05%
Dosage form
EMULSION
Route
OPHTHALMIC
TE code
AB
Application
ANDA 203880
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.
