Orange Book product · Brand (NDA)
SANDIMMUNE
CYCLOSPORINE
At a glance
Nov 23, 1992
Approved
Brand (NDA)
Application
BX
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 23, 1992
34 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CYCLOSPORINE
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
BX
Application
NDA 050625
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 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
- 2025CYCLOSPORINEGeneric (ANDA)
ANDA 219049 · QILU
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.
